Cardiovascular Inflammation Reduction Trial "CIRT"

Active, not recruiting

Phase 3 Results N/A

Update History

6 Apr '18
A location was updated in Birmingham.
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The overall status was removed for University of Alabama at Birmingham.
A location was updated in Fort Payne.
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The overall status was removed for Appalachian Research Associates.
A location was updated in Guntersville.
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The overall status was removed for Avant Research Associates, LLC.
A location was updated in Huntsville.
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The overall status was removed for Saadat Ansari MD LLC.
A location was updated in Mobile.
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The overall status was removed for University of South Alabama: Division of Clinical Research.
A location was updated in COttonwood.
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The overall status was removed for Heart Vascular of Northern Arizona.
A location was updated in Mesa.
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The overall status was removed for CardioVascular Associates of Mesa.
A location was updated in Phoenix.
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The overall status was removed for Arizona Arthritis & Rheumatology Research.
A location was updated in Scottsdale.
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The overall status was removed for Scottsdale Medical Imaging.
A location was updated in Scottsdale.
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The overall status was removed for The Heart Clinic.
A location was updated in Tucson.
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The overall status was removed for Pima Heart.
A location was updated in Tucson.
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The overall status was removed for Southern Arizona VA Health Care System.
A location was updated in Little Rock.
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The overall status was removed for Arkansas Cardiology.
A location was updated in Little Rock.
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The overall status was removed for Arkansas Heart Hospital.
A location was updated in Anaheim.
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The overall status was removed for Oracle Clinical Research, Inc..
A location was updated in Culver City.
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The overall status was removed for Medical Group of Culver City.
A location was updated in Fairfield.
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The overall status was removed for Touro University California- Solano County Affiliated Clinics.
A location was updated in Fresno.
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The overall status was removed for University Of California San Francisco.
A location was updated in Fresno.
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The overall status was removed for VACCHCS.
A location was updated in La Jolla.
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The overall status was removed for UCSD Sulpizio Cardiovascular Center.
A location was updated in La Jolla.
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The overall status was removed for University of California San Diego.
A location was updated in La Quinta.
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The overall status was removed for Desert Medical Care & Wellness.
A location was updated in Lancaster.
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The overall status was removed for Kumar Medical Corporation.
A location was updated in Loma Linda.
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The overall status was removed for Loma Linda University Health.
A location was updated in Loma Linda.
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The overall status was removed for VA Loma Linda Healthcare System.
A location was updated in Long Beach.
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The overall status was removed for Long Beach Center for Clinical Research.
A location was updated in Long Beach.
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The overall status was removed for Cardiovascular Innovation and Research.
A location was updated in Los Alamitos.
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The overall status was removed for Los Alamitos Cardiovascular.
A location was updated in Los Angeles.
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The overall status was removed for Faye Montegrande Md. Clinical Research.
A location was updated in Los Angeles.
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The overall status was removed for Eastside Clinical Research Associates.
A location was updated in Los Angeles.
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The overall status was removed for Salman Khan A. Medical Corporation.
A location was updated in Los Angeles.
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The overall status was removed for University of Southern California.
A location was updated in Los Angeles.
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The overall status was removed for West LA VA Medical Center.
A location was updated in Mather.
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The overall status was removed for VA Northern California Health Care.
A location was updated in Northridge.
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The overall status was removed for Valley Clinical Trials, Inc..
A location was updated in Orange.
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The overall status was removed for Orange County Heart Institute & Research.
A location was updated in Orange.
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The overall status was removed for University of CA Irvine Medical Center.
A location was updated in Oxnard.
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The overall status was removed for Diverse Research Solutions.
A location was updated in Pasadena.
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The overall status was removed for Huntington Memorial Hospital.
A location was updated in Salinas.
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The overall status was removed for Central Coast Cardiology.
A location was updated in San Diego.
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The overall status was removed for Richard G. Friedman, MD.
A location was updated in San Diego.
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The overall status was removed for Ritchken and First MDs.
A location was updated in San Diego.
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The overall status was removed for Foundation for Cardiovascular Medicine.
A location was updated in San Diego.
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The overall status was removed for San Diego Cardiac Center.
A location was updated in San Diego.
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The overall status was removed for Veterans Affairs San Diego Healthcare System.
A location was updated in San Francisco.
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The overall status was removed for UCSF at Zuckerberg SF General Hospital.
A location was updated in Santa Ana.
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The overall status was removed for Coastal Heart Medical Group, Inc..
A location was updated in Santa Maria.
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The overall status was removed for Comprehensive Cardiovascular Care.
A location was updated in Stockton.
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The overall status was removed for Pacific Heart and Vascular Medical Group.
A location was updated in Thousand Oaks.
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The overall status was removed for Manoj D. Aswani M.D..
A location was updated in Vallejo.
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The overall status was removed for Touro University California- Solano Public Health Affiliated Clinics.
A location was updated in Colorado Springs.
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The overall status was removed for Munni R. Selagamsetty, Md, Pc.
A location was updated in Denver.
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The overall status was removed for Vijay - Aurora Denver Cardiology.
A location was updated in Fort Collins.
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The overall status was removed for Colorado Health Medical Group Heart Center of the Rockies.
A location was updated in Fort Collins.
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The overall status was removed for Medical Center of the Rockies Research.
A location was updated in Parker.
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The overall status was removed for Unrein - Rocky Vista University Health Center.
A location was updated in Bridgeport.
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The overall status was removed for Connecticut Heart and Vascular Center.
A location was updated in Bridgeport.
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The overall status was removed for Bridgeport Hospital.
A location was updated in Newark.
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The overall status was removed for Cardiology Physicians/Red Clay Research.
A location was updated in Washington.
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The overall status was removed for Boisey Barnes MD, PC.
A location was updated in Washington.
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The overall status was removed for GWU Medical Faculty Associatin, Inc..
A location was updated in Aventura.
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The overall status was removed for Pianko - Aventura Research Center, LLC.
A location was updated in Boca Raton.
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The overall status was removed for North Ridge Heart Associates.
A location was updated in Clearwater.
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The overall status was removed for St. Francis Medical Institute.
A location was updated in Coral Gables.
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The overall status was removed for Gonzalez MD & Aswad MD Health Ser.
A location was updated in Cutler Bay.
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The overall status was removed for American Research Institute, Inc..
A location was updated in Daytona Beach.
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The overall status was removed for Daytona Heart Group.
A location was updated in Deland.
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The overall status was removed for Daytona Heart Group.
A location was updated in Delray Beach.
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The overall status was removed for Seidman Clinical Trials.
A location was updated in Delray Beach.
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The overall status was removed for Steven Cohen MD.
A location was updated in Doral.
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The overall status was removed for Infinite Clinical Research.
A location was updated in Doral.
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The overall status was removed for International Research Partners, LLC.
A location was updated in Doral.
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The overall status was removed for Medical Research Institute at Doral, Inc..
A location was updated in Eustis.
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The overall status was removed for Lake Internal Medicine Assocaties.
A location was updated in Fort Lauderdale.
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The overall status was removed for Invesclinic.
A location was updated in Fort Myers.
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The overall status was removed for Primary Care Associates.
A location was updated in Fort Myers.
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The overall status was removed for Lee Physician Group.
A location was updated in Gainesville.
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The overall status was removed for The Cardiac and Vascular Institute.
A location was updated in Gainesville.
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The overall status was removed for University of Florida.
A location was updated in Hialeah.
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The overall status was removed for Qway Research.
A location was updated in Hialeah.
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The overall status was removed for State of the Art Research.
A location was updated in Hialeah.
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The overall status was removed for Healing Touch C&C Research.
A location was updated in Hialeah.
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The overall status was removed for Luzmed Clinical Research Institute.
A location was updated in Hialeah.
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The overall status was removed for Viviana Perez MD Research & Cosmetics.
A location was updated in Hialeah.
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The overall status was removed for Elite Cardiac Research Center LLC.
A location was updated in Hialeah.
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The overall status was removed for Nova Clinical Research Clinic.
A location was updated in Hialeah.
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The overall status was removed for Best Quality Research, Inc..
A location was updated in Hollywood.
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The overall status was removed for South Florida Research Solutions, LLC.
A location was updated in Homestead.
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The overall status was removed for John Gutleber Medical Research Office.
A location was updated in Jupiter.
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The overall status was removed for Cardiovascular Medical Associates of Palm Beach.
A location was updated in Kissimmee.
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The overall status was removed for Hope Clinical Research.
A location was updated in Kissimmee.
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The overall status was removed for SIH Research, LLC.
A location was updated in Miami Lakes.
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The overall status was removed for Lakes Research, LLC.
A location was updated in Miami Lakes.
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The overall status was removed for Veritas Research Corp..
A location was updated in Miami Springs.
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The overall status was removed for Ocean Blue Medical Research Center.
A location was updated in Miami.
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The overall status was removed for Medical Research Center of Florida.
A location was updated in Miami.
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The overall status was removed for LG Diagnostics, Inc..
A location was updated in Miami.
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The overall status was removed for St. Paul Medical Research Center, Inc..
A location was updated in Miami.
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The overall status was removed for Team Medical Research.
A location was updated in Miami.
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The overall status was removed for Paradise Clinical Research, LLC.
A location was updated in Miami.
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The overall status was removed for GAD Research Center.
A location was updated in Miami.
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The overall status was removed for Innovation Research Institute, Inc..
A location was updated in Miami.
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The overall status was removed for Sanitas Research.
A location was updated in Miami.
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The overall status was removed for Segui - Med Care Research.
A location was updated in Miami.
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The overall status was removed for South Florida Research Group, LLC.
A location was updated in Miami.
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The overall status was removed for Vista Health Research, LLC.
A location was updated in Miami.
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The overall status was removed for D De La Vega MD Research Group.
A location was updated in Naples.
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The overall status was removed for Southwest Florida Research, LLC.
A location was updated in Orlando.
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The overall status was removed for Orlando Healthy Heart Institute.
A location was updated in Palm Beach Gardens.
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The overall status was removed for Palm Beach Gardens Research Center, LLC.
A location was updated in Pembroke Pines.
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The overall status was removed for Broward Research Center.
A location was updated in Pembroke Pines.
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The overall status was removed for Pioneer Clinical Research.
A location was updated in Pembroke Pines.
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The overall status was removed for Sandoval - Broward Research Center.
A location was updated in Saint Petersburg.
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The overall status was removed for Bay Area Heart Center: 49th Street.
A location was updated in Saint Petersburg.
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The overall status was removed for Bay Area Heart Center: 7th Avenue.
A location was updated in Sweetwater.
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The overall status was removed for Lenus Research & Medical Group.
A location was updated in Tamarac.
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The overall status was removed for DBC Research.
A location was updated in Weeki Wachee.
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The overall status was removed for Asclepes Research Centers.
A location was updated in Wesley Chapel.
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The overall status was removed for Gupta - Premier Heart and Vascular Center.
A location was updated in Athens.
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The overall status was removed for Athens Regional Medical Center.
A location was updated in Atlanta.
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The overall status was removed for Atlanta Veterans Affairs Medical Center.
A location was updated in Atlanta.
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The overall status was removed for Laureate Medical Group at Northside.
A location was updated in Atlanta.
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The overall status was removed for Synergy Therapeutic Partners.
A location was updated in Atlanta.
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The overall status was removed for Northside Hospital.
A location was updated in Cumming.
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The overall status was removed for Atlanta Heart Specialists, LLC.
A location was updated in Dalton.
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The overall status was removed for Heart and Rhythm Specialists.
A location was updated in Dunwoody.
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The overall status was removed for Albert F. Johary MD, PC.
A location was updated in Riverdale.
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The overall status was removed for Infinite Clinical Trials.
A location was updated in Smyrna.
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The overall status was removed for Atlanta Vanguard Medical Associates.
A location was updated in Suwanee.
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The overall status was removed for Herman Clinical Research, LLC.
A location was updated in Tucker.
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The overall status was removed for Atlanta Heart Specialists, LLC.
A location was updated in Vidalia.
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The overall status was removed for Cardiology Associates of Vidalia, P.C..
A location was updated in Honolulu.
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The overall status was removed for VA Pacific Islands Health Care System.
A location was updated in Boise.
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The overall status was removed for St. Luke's Idaho Cardiology Associates.
A location was updated in Idaho Falls.
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The overall status was removed for Clinical Research Prime.
A location was updated in Arlington Heights.
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The overall status was removed for Northwest Heart Clinical Research.
A location was updated in Chicago.
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The overall status was removed for University of Chicago Medical Center.
A location was updated in Chicago.
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The overall status was removed for Advocate Med Group-Heart & Vascular Of Illinois.
A location was updated in Normal.
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The overall status was removed for Illinois Heart & Lung Research Center, Sc.
A location was updated in North Chicago.
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The overall status was removed for Captain James A. Lovell Federal Health.
A location was updated in Olympia Fields.
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The overall status was removed for Specialty Physicians of Illinois, LLC.
A location was updated in Rock Island.
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The overall status was removed for Advanced CardioVascular Consultants.
A location was updated in Dyer.
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The overall status was removed for Cardiospecialists, LTD.
A location was updated in Evansville.
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The overall status was removed for Martin - Martin Family Practice and Research.
A location was updated in Indianapolis.
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The overall status was removed for Krannert Institute Of Cardiology.
A location was updated in Indianapolis.
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The overall status was removed for Community Hospital South.
A location was updated in Indianapolis.
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The overall status was removed for Indiana Heart Physicians.
A location was updated in Muncie.
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The overall status was removed for Medical Consultants, Pc.
A location was updated in West Des Moines.
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The overall status was removed for Iowa Heart Center.
A location was updated in Overland Park.
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The overall status was removed for Stahl - Midwest Heart & Vascular Specialists.
A location was updated in Wichita.
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The overall status was removed for Professional Research Network of KS.
A location was updated in Wichita.
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The overall status was removed for Robert J. Dole VAMC.
A location was updated in Lexington.
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The overall status was removed for University of Kentucky.
A location was updated in Louisville.
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The overall status was removed for Robley Rex VAMC.
A location was updated in Louisville.
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The overall status was removed for Stoddard - University of Louisville.
A location was updated in Louisville.
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The overall status was removed for Bays - L-MARC Research Center.
A location was updated in Owensboro.
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The overall status was removed for Research Integrity LLC.
A location was updated in Covington.
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The overall status was removed for Dorothy H. Banish, MD, APMC Study Group.
A location was updated in Crowley.
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The overall status was removed for Avant Research Associates, LLC.
A location was updated in Hammond.
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The overall status was removed for North Oaks Cardiology.
A location was updated in Marrero.
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The overall status was removed for American Clinical Research, LLC.
A location was updated in Natchitoches.
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The overall status was removed for Otis Barnum D.O.P.C..
A location was updated in New Orleans.
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The overall status was removed for Tulane University Office of Health Research.
A location was updated in Shreveport.
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The overall status was removed for Veterans Affairs Medical Center Shreveport.
A location was updated in Auburn.
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The overall status was removed for Maine Research Associates.
A location was updated in Bangor.
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The overall status was removed for Paul A. Shapero, M.D..
A location was updated in Biddeford.
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The overall status was removed for Southern Maine Health Care.
A location was updated in Portland.
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The overall status was removed for InterMed, PA.
A location was updated in South Portland.
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The overall status was removed for Maine Medical Partners Maine Health Cardiology.
A location was updated in Westbrook.
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The overall status was removed for Maine Centers for Healthcare.
A location was updated in Baltimore.
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The overall status was removed for Sinai Center for Thrombosis Research.
A location was updated in Charlotte Hall.
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The overall status was removed for St. Mary's Medical Center.
A location was updated in Clinton.
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The overall status was removed for Calvert Memorial Hospital.
A location was updated in Prince Frederick.
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The overall status was removed for Shah Associates, MD, LLC.
A location was updated in Salisbury.
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The overall status was removed for Peninsula Cardiology Associates.
A location was updated in Towson.
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The overall status was removed for IRC Clinics.
A location was updated in Boston.
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The overall status was removed for Brigham and Women's Hospital.
A location was updated in Boston.
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The overall status was removed for St. Elizabeth's Medical Center.
A location was updated in Boston.
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The overall status was removed for MGH Cardiology.
A location was updated in Boston.
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The overall status was removed for Joslin Diabetes Center.
A location was updated in Burlington.
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The overall status was removed for Lahey Hospital and Medical Center.
A location was updated in Chelsea.
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The overall status was removed for Massachusetts General Hospital - Chelsea Health Care Center.
A location was updated in Haverhill.
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The overall status was removed for Pentucket Medical Associates, Inc..
A location was updated in Leeds.
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The overall status was removed for VA Central Western Massachusetts Healthca.
A location was updated in Milton.
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The overall status was removed for South Shore Internal Medicine.
A location was updated in Peabody.
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The overall status was removed for Lahey Medical Center.
A location was updated in Salem.
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The overall status was removed for North Shore Cardiovascular Associates.
A location was updated in Worcester.
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The overall status was removed for Reliant Medical Group.
A location was updated in Alpena.
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The overall status was removed for Endeavor Medical Research.
A location was updated in Detroit.
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The overall status was removed for John D. Dingell Veterans Affairs Medical Center.
A location was updated in Detroit.
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The overall status was removed for Trace Research Group at Wayne State University.
A location was updated in Detroit.
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The overall status was removed for Henry Ford Hospital.
A location was updated in Flint.
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The overall status was removed for Flint Clinical Research.
A location was updated in Flint.
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The overall status was removed for Apex Medical Research MI, Inc..
A location was updated in Garden City.
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The overall status was removed for Garden City Hospital.
A location was updated in Grand Blanc.
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The overall status was removed for Genesys Regional Medical Center.
A location was updated in Hamtramck.
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The overall status was removed for National Clinical LLC.
A location was updated in Rochester Hills.
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The overall status was removed for Academic Cardiology Associates PC.
A location was updated in Royal Oak.
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The overall status was removed for Beaumont Health Center.
A location was updated in Saginaw.
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The overall status was removed for Covenant Medical Center, INC..
A location was updated in Saginaw.
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The overall status was removed for Mid-Michigan Heart & Vascular Center.
A location was updated in Saint Cloud.
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The overall status was removed for Centra Care Heart & Vascular Center at St. Cloud Hospital.
A location was updated in Saint Paul.
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The overall status was removed for United Heart and Vascular Clinic.
A location was updated in Gulfport.
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The overall status was removed for Gulfside Clinical Research, LLC.
A location was updated in Jackson.
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The overall status was removed for University of MS Medical Center.
A location was updated in Port Gibson.
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The overall status was removed for David M. Headley M.D. PA Planters Clinic.
A location was updated in Southaven.
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The overall status was removed for Stern Cardiovascular Foundation, Inc..
A location was updated in Bridgeton.
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The overall status was removed for Center for Advanced Medicine and Research LLC.
A location was updated in Columbia.
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The overall status was removed for Clinical Research Center University of Missouri.
A location was updated in Festus.
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The overall status was removed for Quantum Research LLC.
A location was updated in Independence.
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The overall status was removed for Midwest Cardiology Associates.
A location was updated in Joplin.
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The overall status was removed for Freeman Health System.
A location was updated in Kansas City.
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The overall status was removed for VA Medical Center Kansas City.
A location was updated in Osage Beach.
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The overall status was removed for Lake Regional Cardiovascular Institute.
A location was updated in Saint Louis.
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The overall status was removed for VA St. Louis Health Care System (VASTLHCS).
A location was updated in Saint Louis.
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The overall status was removed for SLUCare Cardiology.
A location was updated in Saint Louis.
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The overall status was removed for Washington University.
A location was updated in Saint Louis.
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The overall status was removed for Clinical Investigators LLC.
A location was updated in Saint Louis.
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The overall status was removed for Consult and Research Associates.
A location was updated in Saint Peters.
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The overall status was removed for Center for Advanced Medicine and Research.
A location was updated in Springfield.
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The overall status was removed for CoxHealth: Wheeler Heart & Vascular Center.
A location was updated in Springfield.
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The overall status was removed for Mercy Medical Research Institute.
A location was updated in Great Falls.
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The overall status was removed for Great Falls Clinic Clinical Research Deptartment.
A location was updated in Missoula.
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The overall status was removed for Cone - Montana Medical Research.
A location was updated in La Vista.
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The overall status was removed for Barrett Clinic, P.C..
A location was updated in Omaha.
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The overall status was removed for Heart Consultants.
A location was updated in Omaha.
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The overall status was removed for Alegent Creighton Health.
A location was updated in Omaha.
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The overall status was removed for University of Nebraska Medical Center.
A location was updated in Las Vegas.
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The overall status was removed for Internal Medicine Clinic.
A location was updated in Las Vegas.
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The overall status was removed for Red Rock Clinical Research, LLC.
A location was updated in Reno.
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The overall status was removed for Sierra Nevada Health Care System.
A location was updated in Reno.
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The overall status was removed for Renown Inst for Heart & Vasc Health.
A location was updated in Nashua.
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The overall status was removed for Lahey Cardiology.
A location was updated in Flanders.
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The overall status was removed for Family Health at Mount Olive.
A location was updated in Hillsborough.
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The overall status was removed for Cardiocare.
A location was updated in Linden.
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The overall status was removed for New Jersey Heart.
A location was updated in Neptune.
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The overall status was removed for Jersey Shore University Medical Center.
A location was updated in New Brunswick.
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The overall status was removed for Cardiovascular Institute.
A location was updated in North Bergen.
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The overall status was removed for Palisade Medical Center.
A location was updated in Ridgewood.
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The overall status was removed for The Valley Hospital.
A location was updated in Robbinsville.
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The overall status was removed for Mercer Bucks Cardiology.
A location was updated in Somerset.
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The overall status was removed for Cardio Metabolic Institute.
A location was updated in Teaneck.
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The overall status was removed for Holy Name Medical Center, Inc..
A location was updated in Wayne.
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The overall status was removed for Total Cardiology Care, LLC.
A location was updated in Westwood.
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The overall status was removed for Westwood Cardiology Associates.
A location was updated in Albuquerque.
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The overall status was removed for Presbyterian Heart Group.
A location was updated in Albany.
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The overall status was removed for Albany Medical College.
A location was updated in Albany.
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The overall status was removed for Albany Stratton VA Medical Center.
A location was updated in Bronx.
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The overall status was removed for Novel Research of New York, LLC.
A location was updated in Bronx.
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The overall status was removed for Montefiore Medical Center.
A location was updated in Brooklyn.
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The overall status was removed for Brown - SUNY Downstate Medical Center.
A location was updated in Buffalo.
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The overall status was removed for Buffalo Heart Group.
A location was updated in Cooperstown.
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The overall status was removed for Bassett Healthcare Network.
A location was updated in Cortlandt Manor.
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The overall status was removed for NYU Hudson Valley Cardiology.
A location was updated in Flushing.
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The overall status was removed for NYHQ.
A location was updated in Jamaica.
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The overall status was removed for Jamaica Hospital Medical Center.
A location was updated in Mineola.
New
The overall status was removed for Long Island Heart Associates.
A location was updated in Mineola.
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The overall status was removed for Winthrop University Hospital.
A location was updated in New Hyde Park.
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The overall status was removed for Long Island Jewish Medical Center.
A location was updated in New Hyde Park.
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The overall status was removed for Queens Long Island Medical Group.
A location was updated in New York.
New
The overall status was removed for Chinatown Cardiology, PC.
A location was updated in New York.
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The overall status was removed for Weill Cornell Medical College and NY Presbyterian.
A location was updated in New York.
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The overall status was removed for Mount Sinai School of Medicine.
A location was updated in North Massapequa.
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The overall status was removed for DiGiovanna Institute for Medical Education and Research.
A location was updated in Plattsburgh.
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The overall status was removed for Champlain Valley Physician Hospital.
A location was updated in Schenectady.
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The overall status was removed for Cardiology Associates of Schenectady.
A location was updated in Asheville.
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The overall status was removed for Clinical Study Center of Asheville.
A location was updated in Charlotte.
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The overall status was removed for Metrolina Internal Medicine.
A location was updated in Charlotte.
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The overall status was removed for Gaffney Health Services.
A location was updated in Charlotte.
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The overall status was removed for Carolinas Research Center.
A location was updated in Elizabeth City.
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The overall status was removed for Eastern Carolina Cardiovascular, PA.
A location was updated in Greenville.
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The overall status was removed for Eastern Cardiology.
A location was updated in Lenoir.
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The overall status was removed for Northside Clinical Research.
A location was updated in Mooresville.
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The overall status was removed for Lake Shore Clinical Research, LLC..
A location was updated in Morehead City.
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The overall status was removed for Carteret Medical Group.
A location was updated in Morganton.
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The overall status was removed for Cardiology Associates of Carolinas, PA.
A location was updated in New Bern.
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The overall status was removed for Eastern Nephrology Associates, PLLC.
A location was updated in Rocky Mount.
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The overall status was removed for Boice Willis Clinic.
A location was updated in Sanford.
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The overall status was removed for Sanford Cardiology.
A location was updated in Wilson.
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The overall status was removed for Natalie A. Doyle, MD, PA.
A location was updated in Grand Forks.
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The overall status was removed for Altru Health System Rehab Center.
A location was updated in Akron.
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The overall status was removed for Akron General Medical Center.
A location was updated in Athens.
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The overall status was removed for Ohio University Heritage College of Osteopathic Medicine.
A location was updated in Canton.
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The overall status was removed for Diabetes and Endocrinology Associates of Stark Cit.
A location was updated in Cincinnati.
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The overall status was removed for The Lindner Research Center.
A location was updated in Cleveland.
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The overall status was removed for Cleveland Clinic.
A location was updated in Columbus.
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The overall status was removed for Optimed Research, LTD.
A location was updated in Dayton.
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The overall status was removed for Dayton Heart Center.
A location was updated in Dayton.
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The overall status was removed for Dayton Veteran Affairs Medical Center.
A location was updated in Lancaster.
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The overall status was removed for Colonnade Medical Group.
A location was updated in Middletown.
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The overall status was removed for Middletown Cardiovascular Associates.
A location was updated in Toledo.
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The overall status was removed for Comprehensive Heart Care, Inc..
A location was updated in Westerville.
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The overall status was removed for Mount Carmel Clinical Cardiovascular Care.
A location was updated in Westlake.
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The overall status was removed for Premier Physicians.
A location was updated in Wooster.
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The overall status was removed for Wooster Heart Group.
A location was updated in Lindsay.
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The overall status was removed for Unity Clinical Research.
A location was updated in Oklahoma City.
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The overall status was removed for Cor Clinical Research, Llc.
A location was updated in Oklahoma City.
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The overall status was removed for Thadani - VA Medical Center Oklahoma City, OK.
A location was updated in Oklahoma City.
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The overall status was removed for Today Clinical Research.
A location was updated in Oklahoma City.
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The overall status was removed for Cardiovascular Health Clinic.
A location was updated in Tulsa.
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The overall status was removed for Oklahoma State University Center for Health Sciences.
A location was updated in Corvallis.
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The overall status was removed for Samaritan Health Services.
A location was updated in Medford.
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The overall status was removed for Southern Oregon Cardiology, LLC.
A location was updated in Portland.
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The overall status was removed for Oregon Health & Science University.
A location was updated in Abington.
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The overall status was removed for Center for Clinical Res. Abington Health.
A location was updated in Bethlehem.
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The overall status was removed for St. Luke's University Hospital.
A location was updated in Bristol.
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The overall status was removed for Renu-Ca Research Institute, Lower Bucks Hospital.
A location was updated in Broomall.
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The overall status was removed for Main Line Health Center, Broomall.
A location was updated in Camp Hill.
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The overall status was removed for Spirit Physician Services, Inc.
A location was updated in Chambersburg.
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The overall status was removed for The Chambersburg Hospital.
A location was updated in Doylestown.
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The overall status was removed for Central Bucks Cardiology.
A location was updated in Duncansville.
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The overall status was removed for Altoona Center for Clinical Research.
A location was updated in Ephrata.
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The overall status was removed for Heart Specialists of Lancaster County.
A location was updated in Erie.
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The overall status was removed for Saint Vincent Consultants in Cardiovascular Diseases, LLC.
A location was updated in Feasterville.
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The overall status was removed for Feasterville Family Healthcare Center.
A location was updated in Glen Mills.
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The overall status was removed for Christiana Care Health System.
A location was updated in Harrisburg.
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The overall status was removed for Pinnacle Health Cardiovascular Institute.
A location was updated in Lansdowne.
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The overall status was removed for George Isajiw, MD.
A location was updated in Morrisville.
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The overall status was removed for Bucks County Clinical Research.
A location was updated in Philadelphia.
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The overall status was removed for Drexel University College of Medicine.
A location was updated in Philadelphia.
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The overall status was removed for Hospital of the University of Pennsylvania.
A location was updated in Sellersville.
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The overall status was removed for Lehigh Valley Health Services.
A location was updated in Uniontown.
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The overall status was removed for Pish Medical Associates, Inc..
A location was updated in Whitehall.
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The overall status was removed for Lehigh Valley Family Practice.
A location was updated in Wilkes-Barre.
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The overall status was removed for Wilkes-Barre VA Medical Center.
A location was updated in Cumberland.
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The overall status was removed for Partners in Clinical Research.
A location was updated in Lincoln.
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The overall status was removed for Ocean State Clinical Research Prtnr.
A location was updated in Pawtucket.
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The overall status was removed for Memorial Hospital of Rhode Island.
A location was updated in Providence.
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The overall status was removed for The Miriam Hospital.
A location was updated in Providence.
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The overall status was removed for Ocean State Research Institute, Inc.
A location was updated in Columbia.
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The overall status was removed for South Carolina Heart Center.
A location was updated in Columbia.
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The overall status was removed for Amistad Research Center, LLC.
A location was updated in Indian Land.
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The overall status was removed for Charlotte Hearts.
A location was updated in Irmo.
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The overall status was removed for Miller - SC Internal Medicine Associates.: Irmo.
A location was updated in Pawleys Island.
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The overall status was removed for Inlet Cardiopulmonary & Associates.
A location was updated in Spartanburg.
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The overall status was removed for Fusion Clinical Research of Spartanburg.
A location was updated in Spartanburg.
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The overall status was removed for Palmetto Research Center, LLC.
A location was updated in Chattanooga.
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The overall status was removed for New Phase Research & Development.
A location was updated in Fayetteville.
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The overall status was removed for Parkway Medical Group.
A location was updated in Germantown.
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The overall status was removed for Stern Cardiovascular Foundation, Inc..
A location was updated in Jackson.
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The overall status was removed for Kore Cardiovascular Research Institutue.
A location was updated in Knoxville.
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The overall status was removed for New Phase Research & Development.
A location was updated in Knoxville.
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The overall status was removed for Cardiovascular Research of Knoxville.
A location was updated in Memphis.
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The overall status was removed for Ramanathan - VAMC Memphis.
A location was updated in Nashville.
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The overall status was removed for Clinical Research Center Meharry Medical College.
A location was updated in Austin.
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The overall status was removed for Avant Research Associates LLC.
A location was updated in Austin.
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The overall status was removed for Texas Heart and Vascular Research, LLC.
A location was updated in Beaumont.
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The overall status was removed for Southeast TX Clinical Research Center.
A location was updated in Big Spring.
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The overall status was removed for Cornerstone Family Medicine.
A location was updated in Carrollton.
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The overall status was removed for IMD Medical Center.
A location was updated in Carrollton.
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The overall status was removed for Texas Health Physicians Group.
A location was updated in Dallas.
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The overall status was removed for Cardiovascular Research Institute Of Dallas.
A location was updated in Dallas.
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The overall status was removed for North Texas Health Center.
A location was updated in Dallas.
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The overall status was removed for The Heart Center of Dallas.
A location was updated in DeSoto.
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The overall status was removed for Global Medical Research.
A location was updated in Fort Worth.
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The overall status was removed for The Medical Group of Texas.
A location was updated in Fort Worth.
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The overall status was removed for Texas Health Physicians Group.
A location was updated in Haltom City.
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The overall status was removed for T&R Clinic, P.A..
A location was updated in Houston.
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The overall status was removed for Michele P. Sartori, MD.
A location was updated in Katy.
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The overall status was removed for Grand Medical Care.
A location was updated in Killeen.
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The overall status was removed for Team Research Of Central Texas.
A location was updated in Kingwood.
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The overall status was removed for Houston Heart and Vascular Associates.
A location was updated in Marshall.
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The overall status was removed for Grace Research, LLC.
A location was updated in McAllen.
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The overall status was removed for Valley Heart Consultants.
A location was updated in Mineral Wells.
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The overall status was removed for Heart Center, Palo Pinto General Hospital.
A location was updated in Mission.
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The overall status was removed for Valley Central Research Inc.
A location was updated in North Richland Hills.
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The overall status was removed for North Hills Medical Research, Inc.
A location was updated in Palestine.
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The overall status was removed for Grace Research, LLC.
A location was updated in Port Arthur.
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The overall status was removed for Avant Research Associates, LLC.
A location was updated in San Antonio.
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The overall status was removed for Santoscoy - Health Texas Research Institute.
A location was updated in San Antonio.
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The overall status was removed for Element Research Group.
A location was updated in San Antonio.
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The overall status was removed for Schnitzler Cardiovascular Consultants.
A location was updated in San Antonio.
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The overall status was removed for San Antonio Endovascular & Heart Institute.
A location was updated in Sugar Land.
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The overall status was removed for Acacia Medical Research Institute.
A location was updated in Sugar Land.
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The overall status was removed for Health Plus Clinical Research.
A location was updated in Tomball.
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The overall status was removed for Lone Star Heart and Vascular Center.
A location was updated in Tomball.
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The overall status was removed for Northwest Houston Clinical Research.
A location was updated in Waco.
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The overall status was removed for Hillcrest Family Health Center.
A location was updated in Layton.
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The overall status was removed for Utah Cardiology, P.C..
A location was updated in Salt Lake City.
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The overall status was removed for Utah Diabetes Center.
A location was updated in White River Junction.
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The overall status was removed for VA Medical Center, White River Junction.
A location was updated in Burke.
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The overall status was removed for Burke Internal Medicine & Research.
A location was updated in Falls Church.
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The overall status was removed for Seven Corners Medical Research Center.
A location was updated in Hampton.
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The overall status was removed for Hampton Family Practice Research.
A location was updated in Hampton.
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The overall status was removed for Tidewater Physicians Multispecialty Group.
A location was updated in Manassas.
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The overall status was removed for Virginia Cardiovascular Associates.
A location was updated in Manassas.
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The overall status was removed for Manassas Clinical Research Center.
A location was updated in Mechanicsville.
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The overall status was removed for Tucker Cardiology Associates, P.C..
A location was updated in Newport News.
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The overall status was removed for TPMG Clinical Research.
A location was updated in Norfolk.
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The overall status was removed for Sentara Norfolk General Hospital.
A location was updated in Roanoke.
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The overall status was removed for Roanoke Heart Institute PLC.
A location was updated in Woodbridge.
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The overall status was removed for Cardinal Internal Medicine Associates.
A location was updated in Yorktown.
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The overall status was removed for Tidewater Physicians Multispecialty Group.
A location was updated in Port Orchard.
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The overall status was removed for Frandsen Family Medicine DBA Sound Medi.
A location was updated in Spokane.
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The overall status was removed for Premier Clinical Research.
A location was updated in Spokane.
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The overall status was removed for Kootenai Heart Clinics, LLC.
A location was updated in Spokane.
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The overall status was removed for Northside Internal Medicine.
A location was updated in Vancouver.
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The overall status was removed for Northwest Medical Associates, P.S..
A location was updated in Green Bay.
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The overall status was removed for Cardiology Associates of Bellin Health.
A location was updated in Madison.
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The overall status was removed for Dean Foundation.
A location was updated in Madison.
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The overall status was removed for University Of Wisconsin.
A location was updated in Marshfield.
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The overall status was removed for Marshfield Clinic.
A location was updated in Milwaukee.
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The overall status was removed for Columbia St. Mary's.
A location was updated in Milwaukee.
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The overall status was removed for Aurora St. Luke's Medical Center.
A location was updated in North Vancouver.
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The overall status was removed for The Medical Arts Health Research Group.
A location was updated in Penticton.
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The overall status was removed for The Medical Arts Health Research Group.
A location was updated in Winnipeg.
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The overall status was removed for Winnipeg Clinic.
A location was updated in Brampton.
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The overall status was removed for Bramalea Medical Centre.
A location was updated in Brampton.
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The overall status was removed for Brampton Research Associates.
A location was updated in Burlington.
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The overall status was removed for Philippe R Beaudry Medicine Professional Corporation.
A location was updated in Cambridge.
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The overall status was removed for Vizel Cardiac Research.
A location was updated in Chatham.
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The overall status was removed for Dr. Linda Sinnaeve's Office.
A location was updated in Cornwall.
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The overall status was removed for Scisco Clinical Research.
A location was updated in Guelph.
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The overall status was removed for Dr. Peter Spadafora Health Center.
A location was updated in Hamilton.
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The overall status was removed for John Stimac, MD.
A location was updated in Hamilton.
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The overall status was removed for KMH Cardiology & Diagnostics: Hamilton.
A location was updated in Hamilton.
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The overall status was removed for Dr. William Liang.
A location was updated in Hawkesbury.
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The overall status was removed for Source Unique Clinic.
A location was updated in Kitchener.
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The overall status was removed for Dr. Ronald Fowlis.
A location was updated in London.
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The overall status was removed for University Hospital.
A location was updated in Mississauga.
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The overall status was removed for Malton Medical Research.
A location was updated in Mississauga.
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The overall status was removed for KMH Cardiology & Diagnostics: Mississauga.
A location was updated in Mississauga.
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The overall status was removed for Sewa Ram Singal Medicine Professional Corporation.
A location was updated in Newmarket.
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The overall status was removed for Newmarket Cardiology Research Group.
A location was updated in Newmarket.
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The overall status was removed for Newmarket Cardiology Research Group.
A location was updated in Niagra Falls.
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The overall status was removed for Portage Medical Centre.
A location was updated in North York.
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The overall status was removed for Humber River Regional Hospital.
A location was updated in Oshawa.
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The overall status was removed for Bakbak Medicine Professional Corporation.
A location was updated in Oshawa.
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The overall status was removed for Dr. James Y. Cha.
A location was updated in Ottawa.
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The overall status was removed for University Of Ottawa Heart Institute.
A location was updated in Peterborough.
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The overall status was removed for Kawartha Cardiology Clinical Trials.
A location was updated in Pickering.
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The overall status was removed for Steeple Hill Medical Centre.
A location was updated in Sarnia.
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The overall status was removed for Sarnia Institute of Clinical Research.
A location was updated in Scarborough.
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The overall status was removed for Scarborough Cardiology Research.
A location was updated in Scarborough.
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The overall status was removed for Scarborough General Hospital Cardiology Research Associates.
A location was updated in Scarborough.
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The overall status was removed for Milliken Medical Centre.
A location was updated in Smith Falls.
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The overall status was removed for Canadian Centre for Research on Diabetes.
A location was updated in St. Catharines.
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The overall status was removed for Lake Shore Cardiology.
A location was updated in St. Thomas.
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The overall status was removed for Sardar Medical Clinic.
A location was updated in Sudbury.
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The overall status was removed for G.S. Cardiac Lab Medicine Professional Corp.
A location was updated in Sudbury.
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The overall status was removed for Dr. R. Labonte Professional Med Corp.
A location was updated in Sudbury.
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The overall status was removed for Dr. G. Garrioch, Independent Practice.
A location was updated in Thedford.
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The overall status was removed for Dr. Laurence Gibbs Medicine Professional Corp..
A location was updated in Tillsonburg.
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The overall status was removed for Tillsonburg Medical Centre.
A location was updated in Toronto.
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The overall status was removed for Humber River Hospital.
A location was updated in Toronto.
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The overall status was removed for Sunnybrook Health Sciences Centre.
A location was updated in Toronto.
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The overall status was removed for St. Michael's Hospital.
A location was updated in Toronto.
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The overall status was removed for Mount Sinai Hospital.
A location was updated in Toronto.
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The overall status was removed for Toronto General Hospital.
A location was updated in Toronto.
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The overall status was removed for Weston Road Medical Clinic.
A location was updated in Whitby.
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The overall status was removed for Dr. Nigel Jagan Medicine Professional Corporation.
A location was updated in Windsor.
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The overall status was removed for Dr. Nwadiaro Medicine Professional Corp.
A location was updated in Brossard.
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The overall status was removed for Viacar Recherche Clinique Inc..
A location was updated in Chicoutimi.
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The overall status was removed for Ecogene-21.
A location was updated in Chicoutimi.
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The overall status was removed for Q&T Research Chicoutimi.
A location was updated in Greenfield Park.
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The overall status was removed for Viacar Recherche Clinique Inc..
A location was updated in Montreal.
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The overall status was removed for CHUM Hotel-Dieu.
A location was updated in Quebec City.
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The overall status was removed for Iucpq.
A location was updated in Québec.
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The overall status was removed for ALPHA Recherche Clinique.
A location was updated in Saint-Jean-sur-Richelieu.
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The overall status was removed for CardioVasc HR.
A location was updated in Saint-Lambert.
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The overall status was removed for ViaCar Recherche Clinique Inc.
A location was updated in St. Lambert.
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The overall status was removed for Viacar Recherche Clinique.
A location was updated in Terrebonne.
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The overall status was removed for Hopital Pierre-Le Gardeur.
A location was updated in Quebec.
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The overall status was removed for Recherche Clinique Sigma, Inc..
A location was updated in Bayamón.
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The overall status was removed for Instituto Sanacoop.
A location was updated in Caguas.
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The overall status was removed for San Juan Bautista School of Medicine.
A location was updated in Canovanas.
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The overall status was removed for Norma S. Severino-Pacheco, MD.
A location was updated in Ponce.
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The overall status was removed for Cardiometabolic Research Center.
A location was updated in San Juan.
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The overall status was removed for Miguel Sosa-Padilla, MD.
A location was updated in Toa Baja.
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The overall status was removed for Yolanda Sierra Quinones, MD.
14 Mar '18
A location was updated in Culver City.
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The overall status was updated to "Withdrawn" at Matin - Landmark Clinical Trials, LLC.
A location was updated in San Jose.
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The overall status was updated to "Withdrawn" at Center for Cardiovascular Care.
A location was updated in Cromwell.
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The overall status was updated to "Withdrawn" at Montano - Supreme Clinical Research.
A location was updated in New Britain.
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The overall status was updated to "Withdrawn" at Hospital of Central Connecticut.
A location was updated in Miami.
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The overall status was updated to "Withdrawn" at Policlinica Little Havana.
A location was updated in Miami.
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The overall status was updated to "Withdrawn" at Shelton Medical Services, Inc..
A location was updated in Miami.
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The overall status was updated to "Withdrawn" at Liberty Bell Group, Inc..
A location was updated in Owensboro.
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The overall status was updated to "Withdrawn" at Martin - Health Quest Medical.
A location was updated in Fall River.
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The overall status was updated to "Withdrawn" at NECCR Prima Care Research, LLC.
A location was updated in Missouri City.
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The overall status was updated to "Withdrawn" at Asha Kohli, MD.
A location was updated in Langhorne.
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The overall status was updated to "Withdrawn" at St. Mary Medical Center.
A location was updated in Walterboro.
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The overall status was updated to "Withdrawn" at SC Internal Medicine Associates: Walterboro.
A location was updated in Houston.
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The overall status was updated to "Withdrawn" at Amcare Clinical Research, Inc..
A location was updated in Burlington.
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The overall status was updated to "Withdrawn" at Aviva Clinical Trial Group, Inc.
25 Aug '17
A location was updated in Coral Gables.
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The overall status was removed for Gonzalez MD & Aswad MD Health Ser.
A location was updated in Cutler Bay.
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The overall status was removed for American Research Institute, Inc..
A location was updated in Doral.
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The overall status was removed for Infinite Clinical Research.
A location was updated in Hialeah.
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The overall status was removed for Qway Research.
A location was updated in Hialeah.
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The overall status was removed for State of the Art Research.
A location was updated in Hialeah.
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The overall status was removed for Nova Clinical Research Clinic.
A location was updated in Miami Lakes.
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The overall status was removed for Veritas Research Corp..
A location was updated in Miami Springs.
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The overall status was removed for Ocean Blue Medical Research Center.
A location was updated in Miami.
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The overall status was removed for LG Diagnostics, Inc..
A location was updated in Miami.
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The overall status was removed for Team Medical Research.
A location was updated in Miami.
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The overall status was removed for GAD Research Center.
A location was updated in Miami.
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The overall status was removed for Sanitas Research.
A location was updated in Miami.
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The overall status was removed for Segui - Med Care Research.
A location was updated in Miami.
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The overall status was removed for D De La Vega MD Research Group.
A location was updated in Pembroke Pines.
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The overall status was removed for Broward Research Center.
A location was updated in Pembroke Pines.
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The overall status was removed for Sandoval - Broward Research Center.
A location was updated in Sweetwater.
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The overall status was removed for Lenus Research & Medical Group.
14 Jul '17
The Summary of Purpose was updated.
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The Cardiovascular Inflammation Reduction Trial (CIRT) is a randomized clinical trial investigating whether taking low-dose methotrexate reduces heart attacks, strokes, or death in people with type 2 diabetes or metabolic syndrome that have had a heart attack or multiple coronary blockages. This trial is funded by the National Heart, Lung, and Blood Institute (NHLBI)/National Institutes of Health (NIH).
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The Cardiovascular Inflammation Reduction Trial (CIRT) is a randomized clinical trial investigating whether taking low-dose methotrexate reduces heart attacks, strokes, or death in people with type 2 diabetes or metabolic syndrome that have had a heart attack or multiple coronary blockages. This trial is funded by the National Heart, Lung, and Blood Institute (NHLBI)/National Institutes of Health (NIH).
The description was updated.
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While inflammation contributes crucially to atherothrombosis, it is unknown whether inhibition of inflammation per se will lower vascular event rates. The primary aim of the Cardiovascular Inflammation Reduction Trial (CIRT) is to directly test the inflammatory hypothesis of atherothrombosis by evaluating whether or not low-dose methotrexate (LDM) will reduce rates of myocardial infarction, stroke, and cardiovascular death among stable coronary artery disease patients with type 2 diabetes or metabolic syndrome, conditions associated with an enhanced pro-inflammatory response. CIRT is a randomized, double-blind, placebo-controlled, multi-center, event-driven trial that will randomize 7,000 men and women from the United States and Canada. Following a five- to six-week open-label run-in (maximum 8 weeks), eligible participants who have either suffered documented myocardial infarction in the past or have angiographically demonstrated multivessel coronary artery disease in the past will be randomly allocated over a three to four year period to usual care plus placebo or usual care plus LDM. The target methotrexate dose among those allocated to active therapy is 15 to 20 mg po per week, a dose within the range of that commonly used for the treatment of rheumatoid arthritis. All study participants will additionally receive 1.0 mg oral folate to be taken daily six days per week. LDM complications will be minimized through education programs for all investigators and coordinators, through enhanced communication with study participants, by limiting enrollment to those with no evidence of malignancy, hepatitis, renal dysfunction, chronic infection, pulmonary disease, or other risk factors for toxicity; by conducting an initial 5- to 6-week active-therapy run-in (maximum 8 weeks) designed to eliminate individuals who are either intolerant of or unable to adhere to treatment before randomization; and through regular monitoring of liver function and hematologic indices using a centralized methodology designed to ensure participant safety, allow for dose adjustments while maintaining the study blind, and provide an efficient method to address issues of compliance and follow-up on a cost-effective centralized basis. The primary trial endpoint is the rate of myocardial infarction, stroke, or cardiovascular death. Secondary and tertiary endpoints include all-cause mortality, coronary revascularization, incident congestive heart failure, incident peripheral artery disease, incident venous thrombosis, clinically significant aortic stenosis, incident atrial fibrillation, incident diabetes among those with metabolic syndrome but not diabetes at study entry, and hemoglobin A1c (HbA1c) control among those with diabetes at study entry. The trial is event driven such that in the absence of extreme effects, the trial will conclude after accrual of at least 530 primary endpoints, an effect estimated to provide 90 percent power to detect a 25 percent relative risk reduction. The potential clinical impact of CIRT is broad as it has sufficient power to directly address core issues in the inflammatory hypothesis of atherothrombosis, and thus, if successful, will open major new directions for cardiovascular treatment.
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While inflammation contributes crucially to atherothrombosis, it is unknown whether inhibition of inflammation per se will lower vascular event rates. The primary aim of the Cardiovascular Inflammation Reduction Trial (CIRT) is to directly test the inflammatory hypothesis of atherothrombosis by evaluating whether or not low-dose methotrexate (LDM) will reduce rates of myocardial infarction, stroke, and cardiovascular death among stable coronary artery disease patients with type 2 diabetes or metabolic syndrome, conditions associated with an enhanced pro-inflammatory response. CIRT is a randomized, double-blind, placebo-controlled, multi-center, event-driven trial that will randomize 7,000 men and women from the United States and Canada. Following a five- to six-week open-label run-in (maximum 8 weeks), eligible participants who have either suffered documented myocardial infarction in the past or have angiographically demonstrated multivessel coronary artery disease in the past will be randomly allocated over a three to four year period to usual care plus placebo or usual care plus LDM. The target methotrexate dose among those allocated to active therapy is 15 to 20 mg po per week, a dose within the range of that commonly used for the treatment of rheumatoid arthritis. All study participants will additionally receive 1.0 mg oral folate to be taken daily six days per week. LDM complications will be minimized through education programs for all investigators and coordinators, through enhanced communication with study participants, by limiting enrollment to those with no evidence of malignancy, hepatitis, renal dysfunction, chronic infection, pulmonary disease, or other risk factors for toxicity; by conducting an initial 5- to 6-week active-therapy run-in (maximum 8 weeks) designed to eliminate individuals who are either intolerant of or unable to adhere to treatment before randomization; and through regular monitoring of liver function and hematologic indices using a centralized methodology designed to ensure participant safety, allow for dose adjustments while maintaining the study blind, and provide an efficient method to address issues of compliance and follow-up on a cost-effective centralized basis. The primary trial endpoint is the rate of myocardial infarction, stroke, or cardiovascular death. Secondary and tertiary endpoints include all-cause mortality, coronary revascularization, incident congestive heart failure, incident peripheral artery disease, incident venous thrombosis, clinically significant aortic stenosis, incident atrial fibrillation, incident diabetes among those with metabolic syndrome but not diabetes at study entry, and hemoglobin A1c (HbA1c) control among those with diabetes at study entry. The trial is event driven such that in the absence of extreme effects, the trial will conclude after accrual of at least 530 primary endpoints, an effect estimated to provide 90 percent power to detect a 25 percent relative risk reduction. The potential clinical impact of CIRT is broad as it has sufficient power to directly address core issues in the inflammatory hypothesis of atherothrombosis, and thus, if successful, will open major new directions for cardiovascular treatment.
The gender criteria for eligibility was updated to "All."
The eligibility criteria were updated.
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Inclusion Criteria: - Age ≥ 18 years at screening - Documented past history of myocardial infarction OR past evidence of multivessel coronary artery disease by angiography. - To qualify on the basis of past history of myocardial infarction, the event must be documented either by hospital records or by evidence on current ECG of Q waves in two contiguous leads and/or an imaging test demonstrating wall motion abnormality or scar. The patient must also have completed any planned coronary revascularization procedures associated with the qualifying event, and be clinically stable for at least 60 days prior to screening. - To qualify on the basis of multivessel coronary disease, there must be past angiographic evidence of atherosclerosis in at least 2 major epicardial vessels defined either as the presence of a stent, a coronary bypass graft, or an angiographic lesion of 60% or greater. Left main coronary artery disease that has been revascularized with a stent or bypass graft will qualify as multivessel disease, as will the presence of a 50% or greater isolated left main stenosis. The patient must also have completed any planned coronary revascularization procedures associated with the qualifying event, and be clinically stable for at least 60 days prior to screening. - History of type 2 diabetes or metabolic syndrome at time of study enrollment - Willingness to participate as evidenced by signing the study informed consent Exclusion Criteria: - Prior history of chronic infectious disease, tuberculosis, or severe fungal disease; chronic hepatitis B or C infection; renal insufficiency; interstitial pneumonitis, bronchiectasis, or pulmonary fibrosis; known chronic pericardial effusion, pleural effusion, or ascites; chronic liver disease; myeloproliferative disorders in the past 5 years; non-basal cell malignancy or treated lymphoproliferative disease within the past 5 years; known HIV positive; life expectancy of < 3 years; - Chronic inflammatory condition such as lupus or rheumatoid arthritis, ulcerative colitis or Crohn's disease - White blood cell count < 3,500/ul, hematocrit < 32 percent, or platelet count < 75,000/ul - Liver transaminase levels (AST or ALT) >upper limit of normal (ULN) or albumin < the lower limit of normal (LLN); - Creatinine clearance < 40 ml/min as estimated with the Cockroft-Gault equation; - History of alcohol abuse or unwillingness to limit alcohol consumption to less than 4 drinks per week - Women of child bearing potential, even if they are currently using contraception, and women intending to breastfeed. - Men who plan to father children during the study period or who are unwilling to use effective forms of contraception. - Requirement for use of drugs that alter folate metabolism (trimethoprim/sulfamethoxazol) or reduce tubular excretion (probenecid) or known allergies to antibiotics making avoidance of trimethoprim impossible; - Current indication for methotrexate therapy; - Chronic use of oral steroid therapy or other immunosuppressive or biologic response modifiers. Eligible study participants will be encouraged to have up to date pneumococcal and influenza vaccinations as recommended based on their age and underlying medical conditions. - Chest X-ray evidence in the past 12 months of interstitial pneumonitis, bronchiectasis, or pulmonary fibrosis. For participants who do not have a chest X-ray in the prior 12 months, a chest X-ray will be obtained at baseline as part of the study protocol. - New York Heart Association Class IV congestive heart failure.
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Inclusion Criteria: - Age ≥ 18 years at screening - Documented past history of myocardial infarction OR past evidence of multivessel coronary artery disease by angiography. - To qualify on the basis of past history of myocardial infarction, the event must be documented either by hospital records or by evidence on current ECG of Q waves in two contiguous leads and/or an imaging test demonstrating wall motion abnormality or scar. The patient must also have completed any planned coronary revascularization procedures associated with the qualifying event, and be clinically stable for at least 60 days prior to screening. - To qualify on the basis of multivessel coronary disease, there must be past angiographic evidence of atherosclerosis in at least 2 major epicardial vessels defined either as the presence of a stent, a coronary bypass graft, or an angiographic lesion of 60% or greater. Left main coronary artery disease that has been revascularized with a stent or bypass graft will qualify as multivessel disease, as will the presence of a 50% or greater isolated left main stenosis. The patient must also have completed any planned coronary revascularization procedures associated with the qualifying event, and be clinically stable for at least 60 days prior to screening. - History of type 2 diabetes or metabolic syndrome at time of study enrollment - Willingness to participate as evidenced by signing the study informed consent Exclusion Criteria: - Prior history of chronic infectious disease, tuberculosis, or severe fungal disease; chronic hepatitis B or C infection; renal insufficiency; interstitial pneumonitis, bronchiectasis, or pulmonary fibrosis; known chronic pericardial effusion, pleural effusion, or ascites; chronic liver disease; myeloproliferative disorders in the past 5 years; non-basal cell malignancy or treated lymphoproliferative disease within the past 5 years; known HIV positive; life expectancy of < 3 years; - Chronic inflammatory condition such as lupus or rheumatoid arthritis, ulcerative colitis or Crohn's disease - White blood cell count < 3,500/ul, hematocrit < 32 percent, or platelet count < 75,000/ul - Liver transaminase levels (AST or ALT) >upper limit of normal (ULN) or albumin < the lower limit of normal (LLN); - Creatinine clearance < 40 ml/min as estimated with the Cockroft-Gault equation; - History of alcohol abuse or unwillingness to limit alcohol consumption to less than 4 drinks per week - Women of child bearing potential, even if they are currently using contraception, and women intending to breastfeed. - Men who plan to father children during the study period or who are unwilling to use effective forms of contraception. - Requirement for use of drugs that alter folate metabolism (trimethoprim/sulfamethoxazol) or reduce tubular excretion (probenecid) or known allergies to antibiotics making avoidance of trimethoprim impossible; - Current indication for methotrexate therapy; - Chronic use of oral steroid therapy or other immunosuppressive or biologic response modifiers. Eligible study participants will be encouraged to have up to date pneumococcal and influenza vaccinations as recommended based on their age and underlying medical conditions. - Chest X-ray evidence in the past 12 months of interstitial pneumonitis, bronchiectasis, or pulmonary fibrosis. For participants who do not have a chest X-ray in the prior 12 months, a chest X-ray will be obtained at baseline as part of the study protocol. - New York Heart Association Class IV congestive heart failure.
A location was updated in Birmingham.
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The overall status was updated to "Withdrawn" at University of Alabama Birmingham.
A location was updated in Phoenix.
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The overall status was updated to "Withdrawn" at Maricopa Integrated Health System.
A location was updated in Hot Springs.
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The overall status was updated to "Withdrawn" at Michael A. Frais, Cardiologist, P.A..
A location was updated in Monterey.
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The overall status was updated to "Withdrawn" at Central Coast Cardiology.
A location was updated in Moreno Valley.
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The overall status was updated to "Withdrawn" at Spectrum Clinical Research Institute, Inc..
A location was updated in Hialeah.
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The overall status was updated to "Withdrawn" at Diaz - Max. Rehabilitation Center, Inc..
A location was updated in Jacksonville.
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The overall status was updated to "Withdrawn" at Baptist Heart Specialists.
A location was updated in Miami Lakes.
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The overall status was updated to "Withdrawn" at Espinosa - Miami Lakes Research Inc..
A location was updated in Miami.
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The overall status was updated to "Withdrawn" at Gonzalez - Lone Star Research Center.
A location was updated in Miami.
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The overall status was updated to "Withdrawn" at Bioclinical Research Alliance Inc..
A location was updated in Miami.
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The overall status was updated to "Withdrawn" at Garcia - Abel & Buchheim PR, Inc..
A location was updated in Miami.
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The overall status was updated to "Withdrawn" at Cardiovascular Research Center of South Florida.
A location was updated in Tamarac.
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The overall status was updated to "Withdrawn" at Better Care Med of Tamarac.
A location was updated in Virginia Gardens.
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The overall status was updated to "Withdrawn" at Almonte -Virginia Gardens Research.
A location was updated in Conyers.
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The overall status was updated to "Withdrawn" at Rockdale Medical Research Associates.
A location was updated in Valparaiso.
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The overall status was updated to "Withdrawn" at Northwest Indiana Cardiovascular Physicians.
A location was updated in Kansas City.
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The overall status was updated to "Withdrawn" at Saint Luke's Lipid & Diabetes Research.
A location was updated in Lake Success.
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The overall status was updated to "Withdrawn" at ProHealth Care Associates.
A location was updated in Enola.
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The overall status was updated to "Withdrawn" at Gadani Associates.
A location was updated in Channelview.
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The overall status was updated to "Withdrawn" at Willits - Aztec Clinical Research, Inc..
A location was updated in Irving.
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The overall status was updated to "Withdrawn" at Healthcare Associates of Irving.
A location was updated in Pasadena.
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The overall status was updated to "Withdrawn" at Med-Olam Clinical Research, Llc.
A location was updated in Huntington.
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The overall status was updated to "Withdrawn" at Marshall Cardiology.
A location was updated in Toronto.
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The overall status was updated to "Withdrawn" at Women's College Hospital.
25 May '16
A location was updated in Bakersfield.
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The overall status was updated to "Withdrawn" at Central Cardiology Medical Clinic.
A location was updated in Imperial.
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The overall status was updated to "Withdrawn" at Sun Valley Research Center.
A location was updated in Lomita.
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The overall status was updated to "Withdrawn" at Torrance Clinical Research Inc.
A location was updated in Rancho Mirage.
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The overall status was updated to "Withdrawn" at Eisenhower Desert Cardiology Center.
A location was updated in Celebration.
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The overall status was updated to "Withdrawn" at Florida Lung, Asthma and Sleep Specialists.
A location was updated in Fort Myers.
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The overall status was updated to "Withdrawn" at Golden Medical Research, LLC.
A location was updated in Hollywood.
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The overall status was updated to "Withdrawn" at Medical Research Center of Florida.
A location was updated in Miami.
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The overall status was updated to "Withdrawn" at Infinity Research Solutions Inc.
A location was updated in Miami.
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The overall status was updated to "Withdrawn" at A.M. Medical Center & Research.
A location was updated in New Smyma Beach.
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The overall status was updated to "Withdrawn" at Edgewater Medical Research, Inc..
A location was updated in Plantation.
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The overall status was updated to "Withdrawn" at Nova Clinical Research Collaborative.
A location was updated in Plantation.
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The overall status was updated to "Withdrawn" at NOVA Clinical Research Collaborative.
A location was updated in Zephyrhills.
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The overall status was updated to "Withdrawn" at Premier Heart and Vascular Center.
A location was updated in Aurora.
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The overall status was updated to "Withdrawn" at Fox Valley Clinical Research Center.
A location was updated in Peoria.
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The overall status was updated to "Withdrawn" at Unity Point Health CVD Services.
A location was updated in Bossier City.
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The overall status was updated to "Withdrawn" at Grace Research, LLC.
A location was updated in Zachary.
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The overall status was updated to "Withdrawn" at Southern Clinical Research.
A location was updated in Hagerstown.
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The overall status was updated to "Withdrawn" at Hagerstown Heart.
A location was updated in Takoma Park.
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The overall status was updated to "Withdrawn" at Washington Adventist Hospital.
A location was updated in Kansas City.
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The overall status was updated to "Withdrawn" at Truman Medical Center.
A location was updated in Las Vegas.
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The overall status was updated to "Withdrawn" at Accent Clinical Trials.
A location was updated in New York.
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The overall status was updated to "Withdrawn" at Axis Clinical Trials.
A location was updated in New York.
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The overall status was updated to "Withdrawn" at Columbia University Medical Center.
A location was updated in Columbia.
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The overall status was updated to "Withdrawn" at SleepMed of South Carolina.
A location was updated in Dallas.
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The overall status was updated to "Withdrawn" at Dallas Va Medical Center.
A location was updated in Houston.
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The overall status was updated to "Withdrawn" at Cardiology Consultants of Houston.
A location was updated in San Antonio.
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The overall status was updated to "Withdrawn" at Cardiac Research Associates.
A location was updated in San Antonio.
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The overall status was updated to "Withdrawn" at Cardiac Research Associates.
A location was updated in Kelowna.
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The overall status was updated to "Withdrawn" at The Medical Arts Health Research Group.
A location was updated in Fort Erie.
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The overall status was updated to "Withdrawn" at C & L Research.
A location was updated in Hawkesbury.
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The overall status was updated to "Withdrawn" at Source Unique Clinic.
A location was updated in Kitchener.
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The overall status was updated to "Withdrawn" at KMH Cardiology & Diagnostics: Kitchener.
A location was updated in Thornbury.
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The overall status was updated to "Withdrawn" at Blue Mountain Corn Health Center.
17 Nov '15
The description was updated.
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While inflammation contributes crucially to atherothrombosis, it is unknown whether inhibition of inflammation per se will lower vascular event rates. The primary aim of the Cardiovascular Inflammation Reduction Trial (CIRT) is to directly test the inflammatory hypothesis of atherothrombosis by evaluating whether or not low-dose methotrexate (LDM) will reduce rates of myocardial infarction, stroke, and cardiovascular death among stable coronary artery disease patients with type 2 diabetes or metabolic syndrome, conditions associated with an enhanced pro-inflammatory response. CIRT is a randomized, double-blind, placebo-controlled, multi-center, event-driven trial that will randomize 7,000 men and women from the United States and Canada. Following a five- to six-week open-label run-in (maximum 8 weeks), eligible participants who have either suffered documented myocardial infarction in the past or have angiographically demonstrated multivessel coronary artery disease in the past will be randomly allocated over a three to four year period to usual care plus placebo or usual care plus LDM. The target methotrexate dose among those allocated to active therapy is 15 to 20 mg po per week, a dose within the range of that commonly used for the treatment of rheumatoid arthritis. All study participants will additionally receive 1.0 mg oral folate to be taken daily six days per week. LDM complications will be minimized through education programs for all investigators and coordinators, through enhanced communication with study participants, by limiting enrollment to those with no evidence of malignancy, hepatitis, renal dysfunction, chronic infection, pulmonary disease, or other risk factors for toxicity; by conducting an initial 5- to 6-week active-therapy run-in (maximum 8 weeks) designed to eliminate individuals who are either intolerant of or unable to adhere to treatment before randomization; and through regular monitoring of liver function and hematologic indices using a centralized methodology designed to ensure participant safety, allow for dose adjustments while maintaining the study blind, and provide an efficient method to address issues of compliance and follow-up on a cost-effective centralized basis. The primary trial endpoint is the rate of myocardial infarction, stroke, or cardiovascular death. Secondary and tertiary endpoints include all-cause mortality, coronary revascularization, incident congestive heart failure, incident peripheral artery disease, incident venous thrombosis, clinically significant aortic stenosis, incident atrial fibrillation, incident diabetes among those with metabolic syndrome but not diabetes at study entry, and hemoglobin A1c (HbA1c) control among those with diabetes at study entry. The trial is event driven such that in the absence of extreme effects, the trial will conclude after accrual of at least 530 primary endpoints, an effect estimated to provide 90 percent power to detect a 25 percent relative risk reduction. The potential clinical impact of CIRT is broad as it has sufficient power to directly address core issues in the inflammatory hypothesis of atherothrombosis, and thus, if successful, will open major new directions for cardiovascular treatment.
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While inflammation contributes crucially to atherothrombosis, it is unknown whether inhibition of inflammation per se will lower vascular event rates. The primary aim of the Cardiovascular Inflammation Reduction Trial (CIRT) is to directly test the inflammatory hypothesis of atherothrombosis by evaluating whether or not low-dose methotrexate (LDM) will reduce rates of myocardial infarction, stroke, and cardiovascular death among stable coronary artery disease patients with type 2 diabetes or metabolic syndrome, conditions associated with an enhanced pro-inflammatory response. CIRT is a randomized, double-blind, placebo-controlled, multi-center, event-driven trial that will randomize 7,000 men and women from the United States and Canada. Following a five- to six-week open-label run-in (maximum 8 weeks), eligible participants who have either suffered documented myocardial infarction in the past or have angiographically demonstrated multivessel coronary artery disease in the past will be randomly allocated over a three to four year period to usual care plus placebo or usual care plus LDM. The target methotrexate dose among those allocated to active therapy is 15 to 20 mg po per week, a dose within the range of that commonly used for the treatment of rheumatoid arthritis. All study participants will additionally receive 1.0 mg oral folate to be taken daily six days per week. LDM complications will be minimized through education programs for all investigators and coordinators, through enhanced communication with study participants, by limiting enrollment to those with no evidence of malignancy, hepatitis, renal dysfunction, chronic infection, pulmonary disease, or other risk factors for toxicity; by conducting an initial 5- to 6-week active-therapy run-in (maximum 8 weeks) designed to eliminate individuals who are either intolerant of or unable to adhere to treatment before randomization; and through regular monitoring of liver function and hematologic indices using a centralized methodology designed to ensure participant safety, allow for dose adjustments while maintaining the study blind, and provide an efficient method to address issues of compliance and follow-up on a cost-effective centralized basis. The primary trial endpoint is the rate of myocardial infarction, stroke, or cardiovascular death. Secondary and tertiary endpoints include all-cause mortality, coronary revascularization, incident congestive heart failure, incident peripheral artery disease, incident venous thrombosis, clinically significant aortic stenosis, incident atrial fibrillation, incident diabetes among those with metabolic syndrome but not diabetes at study entry, and hemoglobin A1c (HbA1c) control among those with diabetes at study entry. The trial is event driven such that in the absence of extreme effects, the trial will conclude after accrual of at least 530 primary endpoints, an effect estimated to provide 90 percent power to detect a 25 percent relative risk reduction. The potential clinical impact of CIRT is broad as it has sufficient power to directly address core issues in the inflammatory hypothesis of atherothrombosis, and thus, if successful, will open major new directions for cardiovascular treatment.
The eligibility criteria were updated.
New
Inclusion Criteria: - Age ≥ 18 years at screening - Documented past history of myocardial infarction OR past evidence of multivessel coronary artery disease by angiography. - To qualify on the basis of past history of myocardial infarction, the event must be documented either by hospital records or by evidence on current ECG of Q waves in two contiguous leads and/or an imaging test demonstrating wall motion abnormality or scar. The patient must also have completed any planned coronary revascularization procedures associated with the qualifying event, and be clinically stable for at least 60 days prior to screening. - To qualify on the basis of multivessel coronary disease, there must be past angiographic evidence of atherosclerosis in at least 2 major epicardial vessels defined either as the presence of a stent, a coronary bypass graft, or an angiographic lesion of 60% or greater. Left main coronary artery disease that has been revascularized with a stent or bypass graft will qualify as multivessel disease, as will the presence of a 50% or greater isolated left main stenosis. The patient must also have completed any planned coronary revascularization procedures associated with the qualifying event, and be clinically stable for at least 60 days prior to screening. - History of type 2 diabetes or metabolic syndrome at time of study enrollment - Willingness to participate as evidenced by signing the study informed consent Exclusion Criteria: - Prior history of chronic infectious disease, tuberculosis, or severe fungal disease; chronic hepatitis B or C infection; renal insufficiency; interstitial pneumonitis, bronchiectasis, or pulmonary fibrosis; known chronic pericardial effusion, pleural effusion, or ascites; chronic liver disease; myeloproliferative disorders in the past 5 years; non-basal cell malignancy or treated lymphoproliferative disease within the past 5 years; known HIV positive; life expectancy of < 3 years; - Chronic inflammatory condition such as lupus or rheumatoid arthritis, ulcerative colitis or Crohn's disease - White blood cell count < 3,500/ul, hematocrit < 32 percent, or platelet count < 75,000/ul - Liver transaminase levels (AST or ALT) >upper limit of normal (ULN) or albumin < the lower limit of normal (LLN); - Creatinine clearance < 40 ml/min as estimated with the Cockroft-Gault equation; - History of alcohol abuse or unwillingness to limit alcohol consumption to less than 4 drinks per week - Women of child bearing potential, even if they are currently using contraception, and women intending to breastfeed. - Men who plan to father children during the study period or who are unwilling to use effective forms of contraception. - Requirement for use of drugs that alter folate metabolism (trimethoprim/sulfamethoxazol) or reduce tubular excretion (probenecid) or known allergies to antibiotics making avoidance of trimethoprim impossible; - Current indication for methotrexate therapy; - Chronic use of oral steroid therapy or other immunosuppressive or biologic response modifiers. Eligible study participants will be encouraged to have up to date pneumococcal and influenza vaccinations as recommended based on their age and underlying medical conditions. - Chest X-ray evidence in the past 12 months of interstitial pneumonitis, bronchiectasis, or pulmonary fibrosis. For participants who do not have a chest X-ray in the prior 12 months, a chest X-ray will be obtained at baseline as part of the study protocol. - New York Heart Association Class IV congestive heart failure.
Old
Inclusion Criteria: - Age ≥ 18 years at screening - Documented past history of myocardial infarction OR past evidence of multivessel coronary artery disease by angiography. - To qualify on the basis of past history of myocardial infarction, the event must be documented either by hospital records or by evidence on current ECG of Q waves in two contiguous leads and/or an imaging test demonstrating wall motion abnormality or scar. The patient must also have completed any planned coronary revascularization procedures associated with the qualifying event, and be clinically stable for at least 60 days prior to screening. - To qualify on the basis of multivessel coronary disease, there must be past angiographic evidence of atherosclerosis in at least 2 major epicardial vessels defined either as the presence of a stent, a coronary bypass graft, or an angiographic lesion of 60% or greater. Left main coronary artery disease that has been revascularized with a stent or bypass graft will qualify as multivessel disease, as will the presence of a 50% or greater isolated left main stenosis. The patient must also have completed any planned coronary revascularization procedures associated with the qualifying event, and be clinically stable for at least 60 days prior to screening. - History of type 2 diabetes or metabolic syndrome at time of study enrollment - Willingness to participate as evidenced by signing the study informed consent Exclusion Criteria: - Prior history of chronic infectious disease, tuberculosis, or severe fungal disease; chronic hepatitis B or C infection; renal insufficiency; interstitial pneumonitis, bronchiectasis, or pulmonary fibrosis; known chronic pericardial effusion, pleural effusion, or ascites; chronic liver disease; myeloproliferative disorders in the past 5 years; non-basal cell malignancy or treated lymphoproliferative disease within the past 5 years; known HIV positive; life expectancy of < 3 years; - Chronic inflammatory condition such as lupus or rheumatoid arthritis, ulcerative colitis or Crohn's disease - White blood cell count < 3,500/ul, hematocrit < 32 percent, or platelet count < 75,000/ul - Liver transaminase levels (AST or ALT) >upper limit of normal (ULN) or albumin < the lower limit of normal (LLN); - Creatinine clearance < 40 ml/min as estimated with the Cockroft-Gault equation; - History of alcohol abuse or unwillingness to limit alcohol consumption to less than 4 drinks per week - Women of child bearing potential, even if they are currently using contraception, and women intending to breastfeed. - Men who plan to father children during the study period or who are unwilling to use effective forms of contraception. - Requirement for use of drugs that alter folate metabolism (trimethoprim/sulfamethoxazol) or reduce tubular excretion (probenecid) or known allergies to antibiotics making avoidance of trimethoprim impossible; - Current indication for methotrexate therapy; - Chronic use of oral steroid therapy or other immunosuppressive or biologic response modifiers. Eligible study participants will be encouraged to have up to date pneumococcal and influenza vaccinations as recommended based on their age and underlying medical conditions. - Chest X-ray evidence in the past 12 months of interstitial pneumonitis, bronchiectasis, or pulmonary fibrosis. For participants who do not have a chest X-ray in the prior 12 months, a chest X-ray will be obtained at baseline as part of the study protocol. - New York Heart Association Class IV congestive heart failure.
A location was updated in Tucson.
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The overall status was updated to "Withdrawn" at U of Arizona Medical Center South Campus.
A location was updated in Tucson.
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The overall status was updated to "Withdrawn" at University of Arizona Sarver Heart Center.
A location was updated in Beverly Hills.
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The overall status was updated to "Withdrawn" at Ram Dandillaya MD, Inc..
A location was updated in Los Angeles.
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The overall status was updated to "Withdrawn" at Anthony Mills M.D., Inc..
A location was updated in Los Angeles.
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The overall status was updated to "Withdrawn" at Shervin Eshaghian M.D., Inc. (Beverly Hills Cardiology).
A location was updated in Pismo Beach.
New
The overall status was updated to "Withdrawn" at Arroya Medical Group.
A location was updated in Doral.
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The overall status was updated to "Withdrawn" at Continental Research Corp.
A location was updated in Kissimmee.
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The overall status was updated to "Withdrawn" at Hope Medical Research.
A location was updated in Port Charlotte.
New
The overall status was updated to "Withdrawn" at Cardiology Associates.
A location was updated in Elizabethtown.
New
The overall status was updated to "Withdrawn" at Krishnan Challappa M.D. PSC.
A location was updated in Mt. Sterling.
New
The overall status was updated to "Withdrawn" at Paul McLaughlin MD.
A location was updated in Annapolis.
New
The overall status was updated to "Withdrawn" at Cardiac Consultants, LLC.
A location was updated in Baltimore.
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The overall status was updated to "Withdrawn" at Sinai Hospital of Baltimore.
A location was updated in Hattiesburg.
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The overall status was updated to "Withdrawn" at Hattiesburg Clinic.
A location was updated in Brooklyn.
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The overall status was updated to "Withdrawn" at R.K. Medical Center.
A location was updated in New York.
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The overall status was updated to "Withdrawn" at Associate In Internal Medicine Practice.
A location was updated in Pinehurst.
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The overall status was updated to "Withdrawn" at Pinehurst Medical Clinic, Inc..
A location was updated in Springfield.
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The overall status was updated to "Withdrawn" at Apex Medical Research, Inc..
A location was updated in Yardley.
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The overall status was updated to "Withdrawn" at Jeffry A. Lindenbaum DO, PC.
A location was updated in Irmo.
New
The overall status was updated to "Withdrawn" at SC Internal Medicine Associates: Irmo.
A location was updated in Manning.
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The overall status was updated to "Withdrawn" at Marva D. Williams M.D..
A location was updated in Plano.
New
The overall status was updated to "Withdrawn" at Medical Clinic of North Texas.
A location was updated in Stuart.
New
The overall status was updated to "Withdrawn" at Patrick County Family Practice, PC.
A location was updated in Bolton.
New
The overall status was updated to "Withdrawn" at Goodfellow Medical Centre.
A location was updated in Brampton.
New
The overall status was updated to "Withdrawn" at Wexford Medical Clinic.
A location was updated in Markham.
New
The overall status was updated to "Withdrawn" at Seva Cardiac Centre.
A location was updated in Mississauga.
New
The overall status was updated to "Withdrawn" at Dixie Medical Group.
A location was updated in Windsor.
New
The overall status was updated to "Withdrawn" at Windsor Cardiac Centre.
A location was updated in Saint-Lambert.
New
The overall status was updated to "Withdrawn" at Neufort Inc..
6 Jun '15
A location was updated in Los Angeles.
New
The overall status was updated to "Withdrawn" at Axis Clinical Trials.
A location was updated in Los Angeles.
New
The overall status was updated to "Withdrawn" at Axis Clinical Trials.
A location was updated in National City.
New
The overall status was updated to "Withdrawn" at Albert Sharf, MD.
A location was updated in Wildomar.
New
The overall status was updated to "Withdrawn" at Shiva Heart Center.
A location was updated in Miami.
New
The overall status was updated to "Withdrawn" at Life Spring Research Foundation.
A location was updated in Boise.
New
The overall status was updated to "Withdrawn" at Saint Alphonsus Regional Medical Center.
A location was updated in Hollywood.
New
The overall status was updated to "Withdrawn" at Phillip J. Bean Medical Center.
A location was updated in Pikesville.
New
The overall status was updated to "Withdrawn" at Woodholme Cardiovascular Associates.
A location was updated in Detroit.
New
The overall status was updated to "Withdrawn" at Harris & Associates, PC.
A location was updated in Jersey City.
New
The overall status was updated to "Withdrawn" at Total Cardiology Care, LLC.
A location was updated in Toms River.
New
The overall status was updated to "Withdrawn" at Shore Health Group.
A location was updated in Manhasset.
New
The overall status was updated to "Withdrawn" at Long Island Cardiovascular Consultants.
A location was updated in Washington.
New
The overall status was updated to "Withdrawn" at The Washington Hospital- Cardiovascular Consultants.
A location was updated in West Reading.
New
The overall status was updated to "Withdrawn" at Reading Hospital.
A location was updated in Houston.
New
The overall status was updated to "Withdrawn" at Baylor College of Medicine.
A location was updated in Live Oak.
New
The overall status was updated to "Withdrawn" at Methodist Hospital San Antonio TX.
A location was updated in Southlake.
New
The overall status was updated to "Withdrawn" at Southlake Clinical Trials.
A location was updated in Oshawa.
New
The overall status was updated to "Withdrawn" at King Street Medical Clinic.
A location was updated in Toronto.
New
The overall status was updated to "Withdrawn" at Barbara Erdelyi Medicine Prof Corp.
A location was updated in Mont Royal.
New
The overall status was updated to "Withdrawn" at L'enjeu Medical Center.
A location was updated in Rio Grande.
New
The overall status was updated to "Withdrawn" at Denis Ruiz-Serrano, MD.
25 Nov '14
The description was updated.
New
While inflammation contributes crucially to atherothrombosis, it is unknown whether inhibition of inflammation per se will lower vascular event rates. The primary aim of the Cardiovascular Inflammation Reduction Trial (CIRT) is to directly test the inflammatory hypothesis of atherothrombosis by evaluating whether or not low-dose methotrexate (LDM) will reduce rates of myocardial infarction, stroke, and cardiovascular death among stable coronary artery disease patients with type 2 diabetes or metabolic syndrome, conditions associated with an enhanced pro-inflammatory response. CIRT is a randomized, double-blind, placebo-controlled, multi-center, event-driven trial that will randomize 7,000 men and women from the United States and Canada. Following a five- to six-week open-label run-in (maximum 8 weeks), eligible participants who have either suffered documented myocardial infarction in the past or have angiographically demonstrated multivessel coronary artery disease in the past will be randomly allocated over a three to four year period to usual care plus placebo or usual care plus LDM. The target methotrexate dose among those allocated to active therapy is 15 to 20 mg po per week, a dose within the range of that commonly used for the treatment of rheumatoid arthritis. All study participants will additionally receive 1.0 mg oral folate to be taken daily six days per week. LDM complications will be minimized through education programs for all investigators and coordinators, through enhanced communication with study participants, by limiting enrollment to those with no evidence of malignancy, hepatitis, renal dysfunction, chronic infection, pulmonary disease, or other risk factors for toxicity; by conducting an initial 5- to 6-week active-therapy run-in (maximum 8 weeks) designed to eliminate individuals who are either intolerant of or unable to adhere to treatment before randomization; and through regular monitoring of liver function and hematologic indices using a centralized methodology designed to ensure participant safety, allow for dose adjustments while maintaining the study blind, and provide an efficient method to address issues of compliance and follow-up on a cost-effective centralized basis. The primary trial endpoint is the rate of myocardial infarction, stroke, or cardiovascular death. Secondary and tertiary endpoints include all-cause mortality, coronary revascularization, incident congestive heart failure, incident peripheral artery disease, incident venous thrombosis, clinically significant aortic stenosis, incident atrial fibrillation, incident diabetes among those with metabolic syndrome but not diabetes at study entry, and hemoglobin A1c (HbA1c) control among those with diabetes at study entry. The trial is event driven such that in the absence of extreme effects, the trial will conclude after accrual of at least 530 primary endpoints, an effect estimated to provide 90 percent power to detect a 25 percent relative risk reduction. The potential clinical impact of CIRT is broad as it has sufficient power to directly address core issues in the inflammatory hypothesis of atherothrombosis, and thus, if successful, will open major new directions for cardiovascular treatment.
Old
While inflammation contributes crucially to atherothrombosis, it is unknown whether inhibition of inflammation per se will lower vascular event rates. The primary aim of the Cardiovascular Inflammation Reduction Trial (CIRT) is to directly test the inflammatory hypothesis of atherothrombosis by evaluating whether or not low-dose methotrexate (LDM) will reduce rates of myocardial infarction, stroke, and cardiovascular death among stable coronary artery disease patients with type 2 diabetes or metabolic syndrome, conditions associated with an enhanced pro-inflammatory response. CIRT is a randomized, double-blind, placebo-controlled, multi-center, event-driven trial that will randomize 7,000 men and women from the United States and Canada. Following a five- to six-week open-label run-in (maximum 8 weeks), eligible participants who have either suffered documented myocardial infarction in the past 5 years or have angiographically demonstrated multivessel coronary artery disease in the past five years will be randomly allocated over a three to four year period to usual care plus placebo or usual care plus LDM. The target methotrexate dose among those allocated to active therapy is 15 to 20 mg po per week, a dose within the range of that commonly used for the treatment of rheumatoid arthritis. All study participants will additionally receive 1.0 mg oral folate to be taken daily six days per week. LDM complications will be minimized through education programs for all investigators and coordinators, through enhanced communication with study participants, by limiting enrollment to those with no evidence of malignancy, hepatitis, renal dysfunction, chronic infection, pulmonary disease, or other risk factors for toxicity; by conducting an initial 5- to 6-week active-therapy run-in (maximum 8 weeks) designed to eliminate individuals who are either intolerant of or unable to adhere to treatment before randomization; and through regular monitoring of liver function and hematologic indices using a centralized methodology designed to ensure participant safety, allow for dose adjustments while maintaining the study blind, and provide an efficient method to address issues of compliance and follow-up on a cost-effective centralized basis. The primary trial endpoint is the rate of myocardial infarction, stroke, or cardiovascular death. Secondary and tertiary endpoints include all-cause mortality, coronary revascularization, incident congestive heart failure, incident peripheral artery disease, incident venous thrombosis, clinically significant aortic stenosis, incident atrial fibrillation, incident diabetes among those with metabolic syndrome but not diabetes at study entry, and hemoglobin A1c (HbA1c) control among those with diabetes at study entry. The trial is event driven such that in the absence of extreme effects, the trial will conclude after accrual of at least 530 primary endpoints, an effect estimated to provide 90 percent power to detect a 25 percent relative risk reduction. The potential clinical impact of CIRT is broad as it has sufficient power to directly address core issues in the inflammatory hypothesis of atherothrombosis, and thus, if successful, will open major new directions for cardiovascular treatment.
The eligibility criteria were updated.
New
Inclusion Criteria: - Age ≥ 18 years at screening - Documented past history of myocardial infarction OR past evidence of multivessel coronary artery disease by angiography. - To qualify on the basis of past history of myocardial infarction, the event must be documented either by hospital records or by evidence on current ECG of Q waves in two contiguous leads and/or an imaging test demonstrating wall motion abnormality or scar. The patient must also have completed any planned coronary revascularization procedures associated with the qualifying event, and be clinically stable for at least 60 days prior to screening. - To qualify on the basis of multivessel coronary disease, there must be past angiographic evidence of atherosclerosis in at least 2 major epicardial vessels defined either as the presence of a stent, a coronary bypass graft, or an angiographic lesion of 60% or greater. Left main coronary artery disease that has been revascularized with a stent or bypass graft will qualify as multivessel disease, as will the presence of a 50% or greater isolated left main stenosis. The patient must also have completed any planned coronary revascularization procedures associated with the qualifying event, and be clinically stable for at least 60 days prior to screening. - History of type 2 diabetes or metabolic syndrome at time of study enrollment - Willingness to participate as evidenced by signing the study informed consent Exclusion Criteria: - Prior history of chronic infectious disease, tuberculosis, or severe fungal disease; chronic hepatitis B or C infection; renal insufficiency; interstitial pneumonitis, bronchiectasis, or pulmonary fibrosis; known chronic pericardial effusion, pleural effusion, or ascites; chronic liver disease; myeloproliferative disorders in the past 5 years; non-basal cell malignancy or treated lymphoproliferative disease within the past 5 years; known HIV positive; life expectancy of < 3 years; - Chronic inflammatory condition such as lupus or rheumatoid arthritis, ulcerative colitis or Crohn's disease - White blood cell count < 3,500/ul, hematocrit < 32 percent, or platelet count < 75,000/ul - Liver transaminase levels (AST or ALT) >upper limit of normal (ULN) or albumin < the lower limit of normal (LLN); - Creatinine clearance < 40 ml/min as estimated with the Cockroft-Gault equation; - History of alcohol abuse or unwillingness to limit alcohol consumption to less than 4 drinks per week - Women of child bearing potential, even if they are currently using contraception, and women intending to breastfeed. - Men who plan to father children during the study period or who are unwilling to use effective forms of contraception. - Requirement for use of drugs that alter folate metabolism (trimethoprim/sulfamethoxazol) or reduce tubular excretion (probenecid) or known allergies to antibiotics making avoidance of trimethoprim impossible; - Current indication for methotrexate therapy; - Chronic use of oral steroid therapy or other immunosuppressive or biologic response modifiers. Eligible study participants will be encouraged to have up to date pneumococcal and influenza vaccinations as recommended based on their age and underlying medical conditions. - Chest X-ray evidence in the past 12 months of interstitial pneumonitis, bronchiectasis, or pulmonary fibrosis. For participants who do not have a chest X-ray in the prior 12 months, a chest X-ray will be obtained at baseline as part of the study protocol. - New York Heart Association Class IV congestive heart failure.
Old
Inclusion Criteria: - Age ≥ 18 years at screening - Documented myocardial infarction within the past five years OR evidence of multivessel coronary artery disease by angiography in the past 5 years. - To qualify on the basis of a myocardial infarction in the past 5 years, the event must be documented either by hospital records or by evidence on current ECG of Q waves in two contiguous leads and/or an imaging test demonstrating wall motion abnormality or scar. The patient must also have completed any planned coronary revascularization procedures associated with the qualifying event, and be clinically stable for at least 60 days prior to screening. - To qualify on the basis of multivessel coronary disease, there must be angiographic evidence within the past 5 years of atherosclerosis in at least 2 major epicardial vessels defined either as the presence of a stent, a coronary bypass graft, or an angiographic lesion of 60% or greater. Left main coronary artery disease that has been revascularized with a stent or bypass graft will qualify as multivessel disease, as will the presence of a 50% or greater isolated left main stenosis. The patient must also have completed any planned coronary revascularization procedures associated with the qualifying event, and be clinically stable for at least 60 days prior to screening. - History of type 2 diabetes or metabolic syndrome at time of study enrollment - Willingness to participate as evidenced by signing the study informed consent Exclusion Criteria: - Prior history of chronic infectious disease, tuberculosis, or severe fungal disease; chronic hepatitis B or C infection; renal insufficiency; interstitial pneumonitis, bronchiectasis, or pulmonary fibrosis; known chronic pericardial effusion, pleural effusion, or ascites; chronic liver disease; myeloproliferative disorders in the past 5 years; non-basal cell malignancy or treated lymphoproliferative disease within the past 5 years; known HIV positive; life expectancy of < 3 years; - Chronic inflammatory condition such as lupus or rheumatoid arthritis, ulcerative colitis or Crohn's disease - White blood cell count < 3,500/ul, hematocrit < 32 percent, or platelet count < 75,000/ul - Liver transaminase levels (AST or ALT) >upper limit of normal (ULN) or albumin < the lower limit of normal (LLN); - Creatinine clearance < 40 ml/min as estimated with the Cockroft-Gault equation; - History of alcohol abuse or unwillingness to limit alcohol consumption to less than 4 drinks per week - Women of child bearing potential, even if they are currently using contraception, and women intending to breastfeed. - Men who plan to father children during the study period or who are unwilling to use effective forms of contraception. - Requirement for use of drugs that alter folate metabolism (trimethoprim/sulfamethoxazol) or reduce tubular excretion (probenecid) or known allergies to antibiotics making avoidance of trimethoprim impossible; - Current indication for methotrexate therapy; - Chronic use of oral steroid therapy or other immunosuppressive or biologic response modifiers. Eligible study participants will be encouraged to have up to date pneumococcal and influenza vaccinations as recommended based on their age and underlying medical conditions. - Chest X-ray evidence in the past 12 months of interstitial pneumonitis, bronchiectasis, or pulmonary fibrosis. For participants who do not have a chest X-ray in the prior 12 months, a chest X-ray will be obtained at baseline as part of the study protocol. - New York Heart Association Class IV congestive heart failure.
14 Nov '13
The Summary of Purpose was updated.
New
The Cardiovascular Inflammation Reduction Trial (CIRT) is a randomized clinical trial investigating whether taking low-dose methotrexate reduces heart attacks, strokes, or death in people with type 2 diabetes or metabolic syndrome that have had a heart attack or multiple coronary blockages. This trial is funded by the National Heart, Lung, and Blood Institute (NHLBI)/National Institutes of Health (NIH).
Old
The Cardiovascular Inflammation Reduction Trial (CIRT) is a randomized clinical trial investigating whether taking low-dose methotrexate reduces heart attacks, strokes, or death in people with type 2 diabetes or metabolic syndrome that have had a heart attack. This trial is funded by the National Heart, Lung, and Blood Institute (NHLBI)/National Institutes of Health (NIH).
The description was updated.
New
While inflammation contributes crucially to atherothrombosis, it is unknown whether inhibition of inflammation per se will lower vascular event rates. The primary aim of the Cardiovascular Inflammation Reduction Trial (CIRT) is to directly test the inflammatory hypothesis of atherothrombosis by evaluating whether or not low-dose methotrexate (LDM) will reduce rates of myocardial infarction, stroke, and cardiovascular death among stable coronary artery disease patients with type 2 diabetes or metabolic syndrome, conditions associated with an enhanced pro-inflammatory response. CIRT is a randomized, double-blind, placebo-controlled, multi-center, event-driven trial that will randomize 7,000 men and women from the United States and Canada. Following a five- to six-week open-label run-in (maximum 8 weeks), eligible participants who have either suffered documented myocardial infarction in the past 5 years or have angiographically demonstrated multivessel coronary artery disease in the past five years will be randomly allocated over a three to four year period to usual care plus placebo or usual care plus LDM. The target methotrexate dose among those allocated to active therapy is 15 to 20 mg po per week, a dose within the range of that commonly used for the treatment of rheumatoid arthritis. All study participants will additionally receive 1.0 mg oral folate to be taken daily six days per week. LDM complications will be minimized through education programs for all investigators and coordinators, through enhanced communication with study participants, by limiting enrollment to those with no evidence of malignancy, hepatitis, renal dysfunction, chronic infection, pulmonary disease, or other risk factors for toxicity; by conducting an initial 5- to 6-week active-therapy run-in (maximum 8 weeks) designed to eliminate individuals who are either intolerant of or unable to adhere to treatment before randomization; and through regular monitoring of liver function and hematologic indices using a centralized methodology designed to ensure participant safety, allow for dose adjustments while maintaining the study blind, and provide an efficient method to address issues of compliance and follow-up on a cost-effective centralized basis. The primary trial endpoint is the rate of myocardial infarction, stroke, or cardiovascular death. Secondary and tertiary endpoints include all-cause mortality, coronary revascularization, incident congestive heart failure, incident peripheral artery disease, incident venous thrombosis, clinically significant aortic stenosis, incident atrial fibrillation, incident diabetes among those with metabolic syndrome but not diabetes at study entry, and hemoglobin A1c (HbA1c) control among those with diabetes at study entry. The trial is event driven such that in the absence of extreme effects, the trial will conclude after accrual of at least 530 primary endpoints, an effect estimated to provide 90 percent power to detect a 25 percent relative risk reduction. The potential clinical impact of CIRT is broad as it has sufficient power to directly address core issues in the inflammatory hypothesis of atherothrombosis, and thus, if successful, will open major new directions for cardiovascular treatment.
Old
While inflammation contributes crucially to atherothrombosis, it is unknown whether inhibition of inflammation per se will lower vascular event rates. The primary aim of the Cardiovascular Inflammation Reduction Trial (CIRT) is to directly test the inflammatory hypothesis of atherothrombosis by evaluating whether or not low-dose methotrexate (LDM) will reduce rates of recurrent myocardial infarction, stroke, and cardiovascular death among stable post-myocardial infarction patients with type 2 diabetes or metabolic syndrome, conditions associated with an enhanced pro-inflammatory response. CIRT is a randomized, double-blind, placebo-controlled, multi-center, event-driven trial that will randomize 7,000 men and women from the United States and Canada. Following a five- to six-week open-label run-in (maximum 8 weeks), eligible participants who have suffered documented myocardial infarction in the past five years will be randomly allocated over a three to four year period to usual care plus placebo or usual care plus LDM. The target methotrexate dose among those allocated to active therapy is 15 to 20 mg po per week, a dose within the range of that commonly used for the treatment of rheumatoid arthritis. All study participants will additionally receive 1.0 mg oral folate to be taken daily six days per week. LDM complications will be minimized through education programs for all investigators and coordinators, through enhanced communication with study participants, by limiting enrollment to those with no evidence of malignancy, hepatitis, renal dysfunction, chronic infection, pulmonary disease, or other risk factors for toxicity; by conducting an initial 5- to 6-week active-therapy run-in (maximum 8 weeks) designed to eliminate individuals who are either intolerant of or unable to adhere to treatment before randomization; and through regular monitoring of liver function and hematologic indices using a centralized methodology designed to ensure participant safety, allow for dose adjustments while maintaining the study blind, and provide an efficient method to address issues of compliance and follow-up on a cost-effective centralized basis. The primary trial endpoint is the rate of recurrent myocardial infarction, stroke, or cardiovascular death. Secondary and tertiary endpoints include all-cause mortality, coronary revascularization, incident congestive heart failure, incident peripheral artery disease, incident venous thrombosis, clinically significant aortic stenosis, incident atrial fibrillation, incident diabetes among those with metabolic syndrome but not diabetes at study entry, and hemoglobin A1c (HbA1c) control among those with diabetes at study entry. The trial is event driven such that in the absence of extreme effects, the trial will conclude after accrual of at least 530 primary endpoints, an effect estimated to provide 90 percent power to detect a 25 percent relative risk reduction. The potential clinical impact of CIRT is broad as it has sufficient power to directly address core issues in the inflammatory hypothesis of atherothrombosis, and thus, if successful, will open major new directions for cardiovascular treatment.
The eligibility criteria were updated.
New
Inclusion Criteria: - Age ≥ 18 years at screening - Documented myocardial infarction within the past five years OR evidence of multivessel coronary artery disease by angiography in the past 5 years. - To qualify on the basis of a myocardial infarction in the past 5 years, the event must be documented either by hospital records or by evidence on current ECG of Q waves in two contiguous leads and/or an imaging test demonstrating wall motion abnormality or scar. The patient must also have completed any planned coronary revascularization procedures associated with the qualifying event, and be clinically stable for at least 60 days prior to screening. - To qualify on the basis of multivessel coronary disease, there must be angiographic evidence within the past 5 years of atherosclerosis in at least 2 major epicardial vessels defined either as the presence of a stent, a coronary bypass graft, or an angiographic lesion of 60% or greater. Left main coronary artery disease that has been revascularized with a stent or bypass graft will qualify as multivessel disease, as will the presence of a 50% or greater isolated left main stenosis. The patient must also have completed any planned coronary revascularization procedures associated with the qualifying event, and be clinically stable for at least 60 days prior to screening. - History of type 2 diabetes or metabolic syndrome at time of study enrollment - Willingness to participate as evidenced by signing the study informed consent Exclusion Criteria: - Prior history of chronic infectious disease, tuberculosis, or severe fungal disease; chronic hepatitis B or C infection; renal insufficiency; interstitial pneumonitis, bronchiectasis, or pulmonary fibrosis; known chronic pericardial effusion, pleural effusion, or ascites; chronic liver disease; myeloproliferative disorders in the past 5 years; non-basal cell malignancy or treated lymphoproliferative disease within the past 5 years; known HIV positive; life expectancy of < 3 years; - Chronic inflammatory condition such as lupus or rheumatoid arthritis, ulcerative colitis or Crohn's disease - White blood cell count < 3,500/ul, hematocrit < 32 percent, or platelet count < 75,000/ul - Liver transaminase levels (AST or ALT) >upper limit of normal (ULN) or albumin < the lower limit of normal (LLN); - Creatinine clearance < 40 ml/min as estimated with the Cockroft-Gault equation; - History of alcohol abuse or unwillingness to limit alcohol consumption to less than 4 drinks per week - Women of child bearing potential, even if they are currently using contraception, and women intending to breastfeed. - Men who plan to father children during the study period or who are unwilling to use effective forms of contraception. - Requirement for use of drugs that alter folate metabolism (trimethoprim/sulfamethoxazol) or reduce tubular excretion (probenecid) or known allergies to antibiotics making avoidance of trimethoprim impossible; - Current indication for methotrexate therapy; - Chronic use of oral steroid therapy or other immunosuppressive or biologic response modifiers. Eligible study participants will be encouraged to have up to date pneumococcal and influenza vaccinations as recommended based on their age and underlying medical conditions. - Chest X-ray evidence in the past 12 months of interstitial pneumonitis, bronchiectasis, or pulmonary fibrosis. For participants who do not have a chest X-ray in the prior 12 months, a chest X-ray will be obtained at baseline as part of the study protocol. - New York Heart Association Class IV congestive heart failure.
Old
Inclusion Criteria: - Age ≥ 18 years at screening - Documented myocardial infarction within the past five years, completed any planned coronary revascularization procedures associated with the qualifying event, and have been clinically stable for at least 60 days prior to screening; the qualifying prior myocardial infarction must be documented either by hospital records or by evidence on current ECG of Q waves in two contiguous leads and/or an imaging test demonstrating wall motion abnormality or scar - History of type 2 diabetes or metabolic syndrome at time of study enrollment - Willingness to participate as evidenced by signing the study informed consent Exclusion Criteria: - Prior history of chronic infectious disease, tuberculosis, or severe fungal disease; chronic hepatitis B or C infection; renal insufficiency; interstitial pneumonitis, bronchiectasis, or pulmonary fibrosis; known chronic pericardial effusion, pleural effusion, or ascites; chronic liver disease; myeloproliferative disorders in the past 5 years; non-basal cell malignancy or treated lymphoproliferative disease within the past 5 years; known HIV positive; life expectancy of < 3 years; - Chronic inflammatory condition such as lupus or rheumatoid arthritis, ulcerative colitis or Crohn's disease - White blood cell count < 4,000/ul, hematocrit < 32 percent, or platelet count < 75,000/ul - Liver transaminase levels (AST or ALT) >upper limit of normal (ULN) or albumin < the lower limit of normal (LLN); - Creatinine clearance < 40 ml/min as estimated with the Cockroft-Gault equation; - History of alcohol abuse or unwillingness to limit alcohol consumption to less than 4 drinks per week - Women of child bearing potential, even if they are currently using contraception, and women intending to breastfeed. - Men who plan to father children during the study period or who are unwilling to use effective forms of contraception. - Requirement for use of drugs that alter folate metabolism (trimethoprim/sulfamethoxazol) or reduce tubular excretion (probenecid) or known allergies to antibiotics making avoidance of trimethoprim impossible; - Current indication for methotrexate therapy; - Chronic use of oral steroid therapy or other immunosuppressive or biologic response modifiers. Eligible study participants will be encouraged to have up to date pneumococcal and influenza vaccinations as recommended based on their age and underlying medical conditions. - Chest X-ray evidence in the past 12 months of interstitial pneumonitis, bronchiectasis, or pulmonary fibrosis. For participants who do not have a chest X-ray in the prior 12 months, a chest X-ray will be obtained at baseline as part of the study protocol. - New York Heart Association Class IV congestive heart failure.
6 Apr '13
The description was updated.
New
While inflammation contributes crucially to atherothrombosis, it is unknown whether inhibition of inflammation per se will lower vascular event rates. The primary aim of the Cardiovascular Inflammation Reduction Trial (CIRT) is to directly test the inflammatory hypothesis of atherothrombosis by evaluating whether or not low-dose methotrexate (LDM) will reduce rates of recurrent myocardial infarction, stroke, and cardiovascular death among stable post-myocardial infarction patients with type 2 diabetes or metabolic syndrome, conditions associated with an enhanced pro-inflammatory response. CIRT is a randomized, double-blind, placebo-controlled, multi-center, event-driven trial that will randomize 7,000 men and women from the United States and Canada. Following a five- to six-week open-label run-in (maximum 8 weeks), eligible participants who have suffered documented myocardial infarction in the past five years will be randomly allocated over a three to four year period to usual care plus placebo or usual care plus LDM. The target methotrexate dose among those allocated to active therapy is 15 to 20 mg po per week, a dose within the range of that commonly used for the treatment of rheumatoid arthritis. All study participants will additionally receive 1.0 mg oral folate to be taken daily six days per week. LDM complications will be minimized through education programs for all investigators and coordinators, through enhanced communication with study participants, by limiting enrollment to those with no evidence of malignancy, hepatitis, renal dysfunction, chronic infection, pulmonary disease, or other risk factors for toxicity; by conducting an initial 5- to 6-week active-therapy run-in (maximum 8 weeks) designed to eliminate individuals who are either intolerant of or unable to adhere to treatment before randomization; and through regular monitoring of liver function and hematologic indices using a centralized methodology designed to ensure participant safety, allow for dose adjustments while maintaining the study blind, and provide an efficient method to address issues of compliance and follow-up on a cost-effective centralized basis. The primary trial endpoint is the rate of recurrent myocardial infarction, stroke, or cardiovascular death. Secondary and tertiary endpoints include all-cause mortality, coronary revascularization, incident congestive heart failure, incident peripheral artery disease, incident venous thrombosis, clinically significant aortic stenosis, incident atrial fibrillation, incident diabetes among those with metabolic syndrome but not diabetes at study entry, and hemoglobin A1c (HbA1c) control among those with diabetes at study entry. The trial is event driven such that in the absence of extreme effects, the trial will conclude after accrual of at least 530 primary endpoints, an effect estimated to provide 90 percent power to detect a 25 percent relative risk reduction. The potential clinical impact of CIRT is broad as it has sufficient power to directly address core issues in the inflammatory hypothesis of atherothrombosis, and thus, if successful, will open major new directions for cardiovascular treatment.
Old
While inflammation contributes crucially to atherothrombosis, it is unknown whether inhibition of inflammation per se will lower vascular event rates. The primary aim of the Cardiovascular Inflammation Reduction Trial (CIRT) is to directly test the inflammatory hypothesis of atherothrombosis by evaluating whether or not low-dose methotrexate (LDM) will reduce rates of recurrent myocardial infarction, stroke, and cardiovascular death among stable post-myocardial infarction patients with type 2 diabetes or metabolic syndrome, conditions associated with an enhanced pro-inflammatory response. CIRT is a randomized, double-blind, placebo-controlled, multi-center, event-driven trial that will randomize 7,000 men and women from the United States and Canada. Following a five- to six-week open-label run-in, eligible participants who have suffered documented myocardial infarction in the past five years will be randomly allocated over a three to four year period to usual care plus placebo or usual care plus LDM. The target methotrexate dose among those allocated to active therapy is 15 to 20 mg po per week, a dose within the range of that commonly used for the treatment of rheumatoid arthritis. All study participants will additionally receive 1.0 mg oral folate to be taken daily six days per week. LDM complications will be minimized through education programs for all investigators and coordinators, through enhanced communication with study participants, by limiting enrollment to those with no evidence of malignancy, hepatitis, renal dysfunction, chronic infection, pulmonary disease, or other risk factors for toxicity; by conducting an initial 5- to 6-week active-therapy run-in designed to eliminate individuals who are either intolerant of or unable to adhere to treatment before randomization; and through regular monitoring of liver function and hematologic indices using a centralized methodology designed to ensure participant safety, allow for dose adjustments while maintaining the study blind, and provide an efficient method to address issues of compliance and follow-up on a cost-effective centralized basis. The primary trial endpoint is the rate of recurrent myocardial infarction, stroke, or cardiovascular death. Secondary endpoints include all-cause mortality, incident diabetes among those with metabolic syndrome at study entry; hemoglobin A1c (HbA1c) control among those with diabetes at study entry; incident venous thrombosis; incident congestive heart failure, and incident atrial fibrillation. The trial is event driven such that in the absence of extreme effects, the trial will conclude after accrual of at least 530 primary endpoints, an effect estimated to provide 90 percent power to detect a 25 percent relative risk reduction. The potential clinical impact of CIRT is broad as it has sufficient power to directly address core issues in the inflammatory hypothesis of atherothrombosis, and thus, if successful, will open major new directions for cardiovascular treatment.
The eligibility criteria were updated.
New
Inclusion Criteria: - Age ≥ 18 years at screening - Documented myocardial infarction within the past five years, completed any planned coronary revascularization procedures associated with the qualifying event, and have been clinically stable for at least 60 days prior to screening; the qualifying prior myocardial infarction must be documented either by hospital records or by evidence on current ECG of Q waves in two contiguous leads and/or an imaging test demonstrating wall motion abnormality or scar - History of type 2 diabetes or metabolic syndrome at time of study enrollment - Willingness to participate as evidenced by signing the study informed consent Exclusion Criteria: - Prior history of chronic infectious disease, tuberculosis, or severe fungal disease; chronic hepatitis B or C infection; renal insufficiency; interstitial pneumonitis, bronchiectasis, or pulmonary fibrosis; known chronic pericardial effusion, pleural effusion, or ascites; chronic liver disease; myeloproliferative disorders in the past 5 years; non-basal cell malignancy or treated lymphoproliferative disease within the past 5 years; known HIV positive; life expectancy of < 3 years; - Chronic inflammatory condition such as lupus or rheumatoid arthritis, ulcerative colitis or Crohn's disease - White blood cell count < 4,000/ul, hematocrit < 32 percent, or platelet count < 75,000/ul - Liver transaminase levels (AST or ALT) >upper limit of normal (ULN) or albumin < the lower limit of normal (LLN); - Creatinine clearance < 40 ml/min as estimated with the Cockroft-Gault equation; - History of alcohol abuse or unwillingness to limit alcohol consumption to less than 4 drinks per week - Women of child bearing potential, even if they are currently using contraception, and women intending to breastfeed. - Men who plan to father children during the study period or who are unwilling to use effective forms of contraception. - Requirement for use of drugs that alter folate metabolism (trimethoprim/sulfamethoxazol) or reduce tubular excretion (probenecid) or known allergies to antibiotics making avoidance of trimethoprim impossible; - Current indication for methotrexate therapy; - Chronic use of oral steroid therapy or other immunosuppressive or biologic response modifiers. Eligible study participants will be encouraged to have up to date pneumococcal and influenza vaccinations as recommended based on their age and underlying medical conditions. - Chest X-ray evidence in the past 12 months of interstitial pneumonitis, bronchiectasis, or pulmonary fibrosis. For participants who do not have a chest X-ray in the prior 12 months, a chest X-ray will be obtained at baseline as part of the study protocol. - New York Heart Association Class IV congestive heart failure.
Old
Inclusion Criteria: - Documented myocardial infarction within the past five years AND - Type 2 diabetes AND/OR metabolic syndrome - Completed any planned coronary revascularization procedures - Medically stable for at least 60 days prior to screening - Age ≥ 18 years at screening Exclusion Criteria: - Chronic liver disease - Chronic inflammatory condition such as lupus or rheumatoid arthritis, ulcerative colitis or Crohn's disease - Chronic infectious disease - Interstitial lung disease or pulmonary fibrosis - Myeloproliferative disease in past 5 years - HIV positive - Requirement for, or intolerance to, methotrexate or folate - History of non-basal cell malignancy or treatment for lymphoproliferative disease in past 5 yr - Requirement for use of drugs that alter folate metabolism - History of alcohol abuse or unwillingness to limit consumption to < 4 drinks per week - Women of childbearing potential (even if using oral contraceptive agents) or intention to breastfeed - Men who plan to father children during the study period or are unwilling to use contraception - Life expectancy < 3 years or unlikely to comply in judgment of investigator - Chronic use of oral or IV steroid therapy or other immunosuppressive or biologic response modifiers - History of hepatitis B or C - Chronic pericardial effusion, pleural effusion or ascites - New York Heart Association Class IV heart failure
16 Nov '12
The description was updated.
New
While inflammation contributes crucially to atherothrombosis, it is unknown whether inhibition of inflammation per se will lower vascular event rates. The primary aim of the Cardiovascular Inflammation Reduction Trial (CIRT) is to directly test the inflammatory hypothesis of atherothrombosis by evaluating whether or not low-dose methotrexate (LDM) will reduce rates of recurrent myocardial infarction, stroke, and cardiovascular death among stable post-myocardial infarction patients with type 2 diabetes or metabolic syndrome, conditions associated with an enhanced pro-inflammatory response. CIRT is a randomized, double-blind, placebo-controlled, multi-center, event-driven trial that will randomize 7,000 men and women from the United States and Canada. Following a five- to six-week open-label run-in, eligible participants who have suffered documented myocardial infarction in the past five years will be randomly allocated over a three to four year period to usual care plus placebo or usual care plus LDM. The target methotrexate dose among those allocated to active therapy is 15 to 20 mg po per week, a dose within the range of that commonly used for the treatment of rheumatoid arthritis. All study participants will additionally receive 1.0 mg oral folate to be taken daily six days per week. LDM complications will be minimized through education programs for all investigators and coordinators, through enhanced communication with study participants, by limiting enrollment to those with no evidence of malignancy, hepatitis, renal dysfunction, chronic infection, pulmonary disease, or other risk factors for toxicity; by conducting an initial 5- to 6-week active-therapy run-in designed to eliminate individuals who are either intolerant of or unable to adhere to treatment before randomization; and through regular monitoring of liver function and hematologic indices using a centralized methodology designed to ensure participant safety, allow for dose adjustments while maintaining the study blind, and provide an efficient method to address issues of compliance and follow-up on a cost-effective centralized basis. The primary trial endpoint is the rate of recurrent myocardial infarction, stroke, or cardiovascular death. Secondary endpoints include all-cause mortality, incident diabetes among those with metabolic syndrome at study entry; hemoglobin A1c (HbA1c) control among those with diabetes at study entry; incident venous thrombosis; incident congestive heart failure, and incident atrial fibrillation. The trial is event driven such that in the absence of extreme effects, the trial will conclude after accrual of at least 530 primary endpoints, an effect estimated to provide 90 percent power to detect a 25 percent relative risk reduction. The potential clinical impact of CIRT is broad as it has sufficient power to directly address core issues in the inflammatory hypothesis of atherothrombosis, and thus, if successful, will open major new directions for cardiovascular treatment.
Old
None.
The eligibility criteria were updated.
New
Inclusion Criteria: - Documented myocardial infarction within the past five years AND - Type 2 diabetes AND/OR metabolic syndrome - Completed any planned coronary revascularization procedures - Medically stable for at least 60 days prior to screening - Age ≥ 18 years at screening Exclusion Criteria: - Chronic liver disease - Chronic inflammatory condition such as lupus or rheumatoid arthritis, ulcerative colitis or Crohn's disease - Chronic infectious disease - Interstitial lung disease or pulmonary fibrosis - Myeloproliferative disease in past 5 years - HIV positive - Requirement for, or intolerance to, methotrexate or folate - History of non-basal cell malignancy or treatment for lymphoproliferative disease in past 5 yr - Requirement for use of drugs that alter folate metabolism - History of alcohol abuse or unwillingness to limit consumption to < 4 drinks per week - Women of childbearing potential (even if using oral contraceptive agents) or intention to breastfeed - Men who plan to father children during the study period or are unwilling to use contraception - Life expectancy < 3 years or unlikely to comply in judgment of investigator - Chronic use of oral or IV steroid therapy or other immunosuppressive or biologic response modifiers - History of hepatitis B or C - Chronic pericardial effusion, pleural effusion or ascites - New York Heart Association Class IV heart failure
Old
Inclusion Criteria: - Documented myocardial infarction within the past five years AND - Type 2 diabetes OR metabolic syndrome - Completed any planned coronary revascularization procedures - Medically stable for at least 60 days prior to screening - Age ≥ 18 years at screening Exclusion Criteria: - Chronic liver disease - Chronic inflammatory condition such as lupus or rheumatoid arthritis, ulcerative colitis or Crohn's disease - Chronic infectious disease - Chronic pulmonary disease, such as COPD/emphysema, interstitial lung disease or pulmonary fibrosis - Myeloproliferative disease in past 5 years - HIV positive - Requirement for, or intolerance to, methotrexate or folate - History of non-basal cell malignancy or treatment for lymphoproliferative disease in past 5 yr - Requirement for use of drugs that alter folate metabolism - History of alcohol abuse or unwillingness to limit consumption to ≤ 3 drinks per week - Woman of childbearing potential (even if using oral contraceptive agents) or intention to breastfeed - Men who plan to father children during the study period or are unwilling to use barrier methods of contraception - Life expectancy < 3 years or unlikely to comply in judgment of investigator - Chronic use of oral or IV steroid therapy or other immunosuppressive or biologic response modifiers (see drug list in Manual of Operations) - History of hepatitis B or C - Chronic pericardial effusion, pleural effusion or ascites - New York Heart Association Class IV heart failure
27 Jun '12
The Summary of Purpose was updated.
New
The Cardiovascular Inflammation Reduction Trial (CIRT) is a randomized clinical trial investigating whether taking low-dose methotrexate reduces heart attacks, strokes, or death in people with type 2 diabetes or metabolic syndrome that have had a heart attack. This trial is funded by the National Heart, Lung, and Blood Institute (NHLBI)/National Institutes of Health (NIH).
Old
The Cardiovascular Inflammation Reduction Trial (CIRT) is a randomized clinical trial investigating whether taking low-dose methotrexate reduces heart attacks, strokes, or death in people with type 2 diabetes or metabolic syndrome that have had a heart attack.
Trial was updated to "Phase 3."