Plaque Inflammation and Dysfunctional HDL in AIM-HIGH "HDL Proteomics"

Completed

Phase N/A Results N/A

Update History

15 Apr '17
Trial name was updated.
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Plaque Inflammation and Dysfunctional HDL in AIM-HIGH
The description was updated.
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CHD is the leading cause of death in the United States. Preliminary research has shown that CHD is associated with oxidative and inflammatory changes in high-density lipoprotein (HDL) cholesterol, which is considered the "good" cholesterol. The inflammatory changes can impair HDL cholesterol's normal function, which is to remove excess cholesterol from the arteries and thereby slow the build-up of atherosclerotic plaque. Statins are cholesterol-lowering medications that are used to treat people with CHD. Taking niacin, a type of B vitamin, in combination with statins may stabilize atherosclerotic plaques better than statins alone, but more research is needed to examine how niacin may do this. By improving the ability of HDL cholesterol to repair inflammatory damage to atherosclerotic plaques, niacin may assist in preventing the inflammation that leads to plaque breakdown. The AIM-HIGH study (NCT00120289) is examining the use of niacin plus statins in people with vascular disease. Participants in the AIM-HIGH study are randomly assigned to receive either niacin plus simvastatin, which is a type of statin medication, or simvastatin alone. The purpose of this substudy is to determine whether niacin in combination with statins reduces atherosclerotic plaque inflammation and dysfunctional HDL cholesterol more than statins alone. The substudy will enroll participants who are participating in the AIM-HIGH study. At the AIM-HIGH baseline and Year 2 study visits, study researchers for this substudy will collect an additional blood sample from participants to examine the changes in HDL oxidation levels and protein composition at both time points. Study researchers will also analyze participants' MRI scans to examine changes in plaque inflammation during the study period; these MRI scans will be completed as part of another AIM-HIGH substudy, conducted by Dr. Xue-Qiao Zhao. There will be no additional study procedures or visits for participants in this substudy.
Old
CHD is the leading cause of death in the United States. Preliminary research has shown that CHD is associated with oxidative and inflammatory changes in high-density lipoprotein (HDL) cholesterol, which is considered the "good" cholesterol. The inflammatory changes can impair HDL cholesterol's normal function, which is to remove excess cholesterol from the arteries and thereby slow the build-up of atherosclerotic plaque. Statins are cholesterol-lowering medications that are used to treat people with CHD. Taking niacin, a type of B vitamin, in combination with statins may stabilize atherosclerotic plaques better than statins alone, but more research is needed to examine how niacin may do this. By improving the ability of HDL cholesterol to repair inflammatory damage to atherosclerotic plaques, niacin may assist in preventing the inflammation that leads to plaque breakdown. The AIM-HIGH study (NCT00120289) is examining the use of niacin plus statins in people with vascular disease. Participants in the AIM-HIGH study are randomly assigned to receive either niacin plus simvastain, which is a type of statin medication, or simvastain alone. The purpose of this substudy is to determine whether niacin in combination with statins reduces atherosclerotic plaque inflammation and dysfunctional HDL cholesterol more than statins alone. The substudy will enroll participants who are participating in the AIM-HIGH study. At the AIM-HIGH baseline and Year 2 study visits, study researchers for this substudy will collect an additional blood sample from participants to examine the changes in HDL oxidation levels and protein composition at both time points. Study researchers will also analyze participants' MRI scans to examine changes in plaque inflammation during the study period; these MRI scans will be completed as part of another AIM-HIGH substudy, conducted by Dr. Xue-Qiao Zhao. There will be no additional study procedures or visits for participants in this substudy.
The gender criteria for eligibility was updated to "All."
28 Feb '12
A location was updated in Birmingham.
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The overall status was removed for Cardiovascular Associates.
A location was updated in Phoenix.
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The overall status was removed for Cardiovascular Consultants.
A location was updated in Long Beach.
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The overall status was removed for Long Beach VA Medical Center.
A location was updated in Newark.
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The overall status was removed for Christiana Care Health Services.
A location was updated in Baltimore.
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The overall status was removed for University of Maryland.
A location was updated in Minneapolis.
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The overall status was removed for HealthPartners Riverside Clinic.
A location was updated in Minneapolis.
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The overall status was removed for University of Minnesota.
A location was updated in Rochester.
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The overall status was removed for Mayo Clinic.
A location was updated in Durham.
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The overall status was removed for Duke University.
A location was updated in Greensboro.
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The overall status was removed for Wake Forest University, Geriatrics.
A location was updated in Winston-Salem.
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The overall status was removed for Wake Forest University, Cardiology.
A location was updated in Winston-Salem.
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The overall status was removed for Wake Forest University, Endocrinology.
A location was updated in Cleveland.
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The overall status was removed for St. Vincent Charity Hospital.
A location was updated in Portland.
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The overall status was removed for Portland VA Medical Center.
A location was updated in Philadelphia.
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The overall status was removed for Pennsylvania Cardiology Associates.
A location was updated in Philadelphia.
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The overall status was removed for Cardiology Consultants of Philadelphia.
A location was updated in Philadelphia.
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The overall status was removed for Philadelphia VA Medical Center.
A location was updated in Houston.
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The overall status was removed for Baylor College of Medicine.
A location was updated in Houston.
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The overall status was removed for Kelsey Research Foundation.
A location was updated in Houston.
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The overall status was removed for Methodist Hospital.
A location was updated in Richmond.
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The overall status was removed for McGuire VA Medical Center.
A location was updated in Seattle.
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The overall status was removed for University of Washington.
A location was updated in Seattle.
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The overall status was removed for Harborview Medical Center.
A location was updated in Seattle.
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The overall status was removed for Puget Sound VA Medical Center, Seattle Campus.
A location was updated in Calgary.
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The overall status was removed for University of Calgary.
A location was updated in Calgary.
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The overall status was removed for Heart Health Institute.
A location was updated in Vancouver.
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The overall status was removed for Vancouver General Hospital.
A location was updated in London.
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The overall status was removed for University of Western Ontario.
A location was updated in Toronto.
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The overall status was removed for St. Michael's Health Centre.