Stroke Hyperglycemia Insulin Network Effort (SHINE) Trial "SHINE"

Recruiting

Phase 3 Results N/A

Update History

22 Sep '16
A location was updated in Tucson.
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The overall status was updated to "Active, not recruiting" at University of Arizona.
A location was updated in Tuscon.
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The overall status was updated to "Active, not recruiting" at University of Arizona Medical Center - South Campus.
A location was updated in San Francisco.
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The overall status was updated to "Active, not recruiting" at California Pacific Medical Center - Davies Campus.
A location was updated in San Francisco.
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The overall status was updated to "Active, not recruiting" at UCSF Medical Center.
A location was updated in Atlanta.
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The overall status was updated to "Active, not recruiting" at Emory University Hospital - Midtown.
A location was updated in Peoria.
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The overall status was updated to "Active, not recruiting" at OSF Saint Francis Medical Center.
A location was updated in Royal Oak.
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The overall status was updated to "Active, not recruiting" at William Beaumont Hospital-Royal Oak.
A location was updated in Troy.
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The overall status was updated to "Active, not recruiting" at William Beaumont Hospital-Troy.
A location was updated in New York.
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The overall status was updated to "Active, not recruiting" at Maimonides Medical Center.
A location was updated in Nashville.
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The overall status was updated to "Active, not recruiting" at St. Thomas Neuroscience Research Institute.
A location was updated in Nashville.
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The overall status was updated to "Active, not recruiting" at Vanderbilt University Medical Center.
A location was updated in Austin.
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The overall status was updated to "Active, not recruiting" at University Medical Center Brackenridge, Austin, TX.
26 Apr '16
The Summary of Purpose was updated.
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The Stroke Hyperglycemia Insulin Network Effort (SHINE) Trial is a multicenter, randomized, controlled clinical trial of 1400 patients that will include approximately 60 enrolling sites. The study hypotheses are that treatment of hyperglycemic acute ischemic stroke patients with targeted glucose concentration (80mg/dL - 130 mg/dL) will be safe and result in improved 3 month outcome after stroke. Eligible subjects must be within 12 hours of stroke symptom onset and have diabetes and glucose concentrations of over 110 mg/dL on initial evaluation. The enrolling sites will include the Neurological Emergencies Treatment Trials (NETT) sites as well as non NETT sites from all over the United States. The study will evaluate the safety and efficacy of targeted glucose control (treatment group - IV insulin with target 80-130 mg/dl) verses control therapy of sub q insulin plus basal insulin with target glucose less than 180 mg/ dL. The primary outcome will be functional outcome at 3 months as measured by the modified Rankin Scale (mRS) Score. The primary safety outcome will be severe hypoglycemia defined as <40 mg/dL. Enrollment will occur over 3.5 - 4 years.
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The Stroke Hyperglycemia Insulin Network Effort (SHINE) Trial is a multicenter, randomized, controlled clinical trial of 1400 patients that will include approximately 60 enrolling sites. The study hypotheses are that treatment of hyperglycemic acute ischemic stroke patients with targeted glucose concentration (80mg/dL - 130 mg/dL) will be safe and result in improved 3 month outcome after stroke. Eligible subjects must be within 12 hours of stroke symptom onset and have diabetes and glucose concentrations of over 110 mg/dL on initial evaluation. The enrolling sites will include the Neurological Emergencies Treatment Trials (NETT) sites as well as non NETT sites from all over the United States. The study will evaluate the safety and efficacy of targeted glucose control (treatment group - IV insulin with target 80-130 mg/dl) verses control therapy of sub q insulin plus basal insulin with target glucose less than 180 mg/ dL. The primary outcome will be functional outcome at 3 months as measured by the modified Rankin Scale (mRS) Score. The primary safety outcome will be severe hypoglycemia defined as <40 mg/dL. Enrollment will occur over 3.5 - 4 years.
The eligibility criteria were updated.
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Inclusion Criteria: 1. Age 18 years or older 2. Clinical diagnosis of ischemic stroke defined as acute neurological deficit occurring in one or more cerebral vascular territories. Neuroimaging must be done to exclude intracranial hemorrhage (ICH). 3. Protocol treatment must begin within 12 hours after stroke symptom onset and is recommended, but not required, to begin within 3 hours after hospital arrival. If time of symptom onset is unclear or patient is awakening with stroke symptoms, the time of onset will be the time the patient was last known to be normal. 4. Known history of type 2 diabetes mellitus and glucose >110 mg/dL OR admission blood glucose ≥150 mg/dL in those w/o known diabetes mellitus 5. Baseline NIHSS score of 3-22 6. Pre-stroke modified Rankin Scale score = 0 for patients with an NIHSS score of 3-7. Pre-stroke modified Rankin Scale score = 0 or 1 for patients with an NIHSS score of 8-22. 7. Able to provide a valid informed consent to be in the study (self or their authorized legally accepted representative). The approved consent form must be signed and dated in accordance with federal and institutional guidelines. Exclusion Criteria: 1. Known history of type 1 diabetes mellitus 2. Substantial pre-existing neurological or psychiatric illness that would confound the neurological assessment or other outcome assessment 3. Having received experimental therapy for the enrollment stroke. IV tPA (up to 4.5 hrs) or IA tPA are allowed as are IA therapies including use of FDA cleared devices. Non FDA cleared devices are considered experimental and are excluded. 4. Pregnant or breast-feeding at the time of study entry 5. Other serious conditions that make the patient unlikely to survive 90 days 6. Inability to follow the protocol or return for the 90 day follow up 7. Renal dialysis (including hemo or peritoneal dialysis)
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Inclusion Criteria: 1. Age 18 years or older 2. Clinical diagnosis of ischemic stroke defined as acute neurological deficit occurring in one or more cerebral vascular territories. Neuroimaging must be done to exclude intracranial hemorrhage (ICH). 3. Protocol treatment must begin within 12 hours after stroke symptom onset and is recommended, but not required, to begin within 3 hours after hospital arrival. If time of symptom onset is unclear or patient is awakening with stroke symptoms, the time of onset will be the time the patient was last known to be normal. 4. Known history of type 2 diabetes mellitus and glucose >110 mg/dL OR admission blood glucose ≥150 mg/dL in those w/o known diabetes mellitus 5. Baseline NIHSS score of 3-22 6. Pre-stroke modified Rankin Scale score = 0 for patients with an NIHSS score of 3-7. Pre-stroke modified Rankin Scale score = 0 or 1 for patients with an NIHSS score of 8-22. 7. Able to provide a valid informed consent to be in the study (self or their authorized legally accepted representative). The approved consent form must be signed and dated in accordance with federal and institutional guidelines. Exclusion Criteria: 1. Known history of type 1 diabetes mellitus 2. Substantial pre-existing neurological or psychiatric illness that would confound the neurological assessment or other outcome assessment 3. Having received experimental therapy for the enrollment stroke. IV tPA (up to 4.5 hrs) or IA tPA are allowed as are IA therapies including use of FDA cleared devices. Non FDA cleared devices are considered experimental and are excluded. 4. Pregnant or breast-feeding at the time of study entry 5. Other serious conditions that make the patient unlikely to survive 90 days 6. Inability to follow the protocol or return for the 90 day follow up 7. Renal dialysis (including hemo or peritoneal dialysis)
A location was updated in San Francisco.
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The overall status was updated to "Active, not recruiting" at California Pacific Medical Center-Pacific Campus.
A location was updated in Baltimore.
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The overall status was updated to "Active, not recruiting" at University of Maryland Medical Center.
A location was updated in Detroit.
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The overall status was updated to "Active, not recruiting" at Henry Ford Health System.
A location was updated in Hackensack.
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The overall status was updated to "Active, not recruiting" at Hackensack University Medical Center.
A location was updated in Hershey.
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The overall status was updated to "Active, not recruiting" at Penn State Hershey Medical Center.
A location was updated in Austin.
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The overall status was updated to "Active, not recruiting" at Seton Medical Center.
4 Dec '14
A location was updated in Philadelphia.
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The overall status was updated to "Active, not recruiting" at Jefferson Hospital.
20 Mar '14
A location was updated in Buffalo.
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The overall status was updated to "Recruiting" at Kaleida Stroke Center, SUNY Buffalo.
A location was updated in New York.
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The overall status was updated to "Active, not recruiting" at Weill Cornell Medical Center.
A location was updated in Richmond.
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The overall status was updated to "Active, not recruiting" at Virginia Commonwealth University.
5 Feb '14
A location was updated in Long Beach.
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The overall status was updated to "Recruiting" at Long Beach Memorial Medical Center.
A location was updated in Abington.
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The overall status was updated to "Recruiting" at Abington Memorial Hospital.
21 Nov '13
A location was updated in Detroit.
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The overall status was updated to "Recruiting" at Sinai-Grace Hospital.
14 Nov '13
A location was updated in Tucson.
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The overall status was updated to "Active, not recruiting" at University of Arizona.
8 Nov '13
A location was updated in Brooklyn.
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The overall status was updated to "Recruiting" at SUNY Downstate University Hospital of Brooklyn.
19 Oct '13
A location was updated in New York.
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The overall status was updated to "Active, not recruiting" at Maimonides Medical Center.
30 Aug '13
A location was updated in Bronx.
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The overall status was updated to "Recruiting" at Lincoln Medical and Mental Health Center.
12 Jul '13
A location was updated in San Francisco.
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The overall status was updated to "Active, not recruiting" at UCSF Medical Center.
20 Jun '13
A location was updated in Brooklyn.
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The overall status was updated to "Recruiting" at Kings County Hospital.
11 Jun '13
A location was updated in Pittsburgh.
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The overall status was updated to "Recruiting" at UPMC - Mercy.
1 May '13
A location was updated in Dallas.
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The overall status was updated to "Recruiting" at UT Southwestern.
29 Mar '13
A location was updated in Boston.
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The overall status was updated to "Recruiting" at Massachusetts General Hospital.
22 Mar '13
A location was updated in Troy.
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The overall status was updated to "Active, not recruiting" at William Beaumont Hospital-Troy.
A location was updated in Minneapolis.
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The overall status was updated to "Recruiting" at Hennepin County Medical Center.
22 Feb '13
A location was updated in Richmond.
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The overall status was updated to "Active, not recruiting" at Virginia Commonwealth University.
31 Jan '13
The eligibility criteria were updated.
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Inclusion Criteria: 1. Age 18 years or older 2. Clinical diagnosis of ischemic stroke defined as acute neurological deficit occurring in one or more cerebral vascular territories. Neuroimaging must be done to exclude intracranial hemorrhage (ICH). 3. Protocol treatment must begin within 12 hours after stroke symptom onset and is recommended, but not required, to begin within 3 hours after hospital arrival. If time of symptom onset is unclear or patient is awakening with stroke symptoms, the time of onset will be the time the patient was last known to be normal. 4. Known history of type 2 diabetes mellitus and glucose >110 mg/dL OR admission blood glucose ≥150 mg/dL in those w/o known diabetes mellitus 5. Baseline NIHSS score of 3-22 6. Pre-stroke modified Rankin Scale score = 0 for patients with an NIHSS score of 3-7. Pre-stroke modified Rankin Scale score = 0 or 1 for patients with an NIHSS score of 8-22. 7. Able to provide a valid informed consent to be in the study (self or their authorized legally accepted representative). The approved consent form must be signed and dated in accordance with federal and institutional guidelines. Exclusion Criteria: 1. Known history of type 1 diabetes mellitus 2. Substantial pre-existing neurological or psychiatric illness that would confound the neurological assessment or other outcome assessment 3. Having received experimental therapy for the enrollment stroke. IV tPA (up to 4.5 hrs) or IA tPA are allowed as are IA therapies including use of FDA cleared devices. Non FDA cleared devices are considered experimental and are excluded. 4. Pregnant or breast-feeding at the time of study entry 5. Other serious conditions that make the patient unlikely to survive 90 days 6. Inability to follow the protocol or return for the 90 day follow up 7. Renal dialysis (including hemo or peritoneal dialysis)
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Inclusion Criteria: 1. Age 18 years or older 2. Clinical diagnosis of ischemic stroke defined as acute neurological deficit occurring in one or more cerebral vascular territories. Neuroimaging must be done to exclude intracranial hemorrhage (ICH). 3. Protocol treatment must begin within 3 hours after hospital arrival and within 12 hours after stroke symptom onset. If time of symptom onset is unclear or patient is awakening with stroke symptoms, the time of onset will be the time last known to be well. 4. Known history of type 2 diabetes mellitus and glucose >110 mg/dL OR admission blood glucose ≥150 mg/dL in those w/o known diabetes mellitus 5. Baseline NIHSS score of 3-22 6. Pre-stroke Modified Rankin Scale score = 0 7. Able to provide a valid informed consent to be in the study (self or their authorized legally accepted representative). The approved consent form must be signed and dated in accordance with federal and institutional guidelines. Exclusion Criteria: 1. Known history of type 1 diabetes mellitus 2. Substantial pre-existing neurological or psychiatric illness that would confound the neurological assessment or other outcome assessment 3. Having received experimental therapy for the enrollment stroke. IV tPA (up to 4.5 hrs) or IA tPA are allowed as are IA therapies including use of FDA cleared devices. Non FDA cleared devices are considered experimental and are excluded. 4. Pregnant or breast-feeding at the time of study entry 5. Other serious conditions that make the patient unlikely to survive 90 days 6. Inability to follow the protocol or return for the 90 day follow up 7. Renal dialysis (including hemo or peritoneal dialysis)
A location was updated in Detroit.
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The overall status was updated to "Active, not recruiting" at Henry Ford Health System.
A location was updated in Hackensack.
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The overall status was updated to "Active, not recruiting" at Hackensack University Medical Center.
10 Jan '13
A location was updated in Columbus.
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The overall status was updated to "Recruiting" at Wexner Medical Center.
A location was updated in Pittsburgh.
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The overall status was updated to "Recruiting" at UPMC Presbyterian.
7 Dec '12
A location was updated in Minneapolis.
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The overall status was updated to "Recruiting" at University of Minnesota Medical Center, Fairview.
28 Nov '12
A location was updated in Detroit.
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The overall status was updated to "Recruiting" at Detroit Receiving Hospital.
24 Nov '12
A location was updated in Houston.
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The overall status was updated to "Recruiting" at Baylor College of Medicine.
20 Nov '12
A location was updated in Seattle.
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The overall status was updated to "Recruiting" at Harborview Medical Center.
2 Oct '12
A location was updated in Stanford.
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The overall status was updated to "Recruiting" at Stanford University.
28 Aug '12
A location was updated in Royal Oak.
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The overall status was updated to "Active, not recruiting" at William Beaumont Hospital-Royal Oak.
3 Aug '12
A location was updated in New York.
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The overall status was updated to "Recruiting" at Columbia University Medical Center.
27 Jul '12
A location was updated in Philadelphia.
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The overall status was updated to "Recruiting" at University of Pennsylvania.
29 Jun '12
A location was updated in Philadelphia.
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The overall status was updated to "Recruiting" at Temple University.
12 Jun '12
A location was updated in Jacksonville.
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The overall status was updated to "Recruiting" at Mayo Jacksonville.
A location was updated in Hershey.
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The overall status was updated to "Recruiting" at Penn State.
2 Jun '12
A location was updated in Pittsburgh.
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The overall status was updated to "Recruiting" at Allegheny General Hospital.
26 May '12
A location was updated in San Francisco.
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The overall status was updated to "Recruiting" at San Francisco General Hospital.
A location was updated in Lexington.
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The overall status was updated to "Recruiting" at University of Kentucky.
16 May '12
A location was updated in Milwaukee.
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The overall status was updated to "Recruiting" at Froedtert Memorial Hospital.
2 May '12
A location was updated in Atlanta.
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The overall status was updated to "Recruiting" at Emory University.
A location was updated in Cincinnati.
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The overall status was updated to "Recruiting" at University of Cincinnati.
A location was updated in Houston.
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The overall status was updated to "Recruiting" at University of Texas Houston.
A location was updated in Morgantown.
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The overall status was updated to "Recruiting" at West Virginia University.
14 Apr '12
A location was updated in Baltimore.
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The overall status was updated to "Recruiting" at University of Maryland.
13 Apr '12
A location was updated in Augusta.
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The overall status was updated to "Recruiting" at Georgia Health Sciences University.
12 Apr '12
A location was updated in Salt Lake City.
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The overall status was updated to "Recruiting" at University of Utah.
22 Mar '12
The Summary of Purpose was updated.
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The Stroke Hyperglycemia Insulin Network Effort (SHINE) Trial is a multicenter, randomized, controlled clinical trial of 1400 patients that will include approximately 60 enrolling sites. The study hypotheses are that treatment of hyperglycemic acute ischemic stroke patients with targeted glucose concentration (80mg/dL - 130 mg/dL) will be safe and result in improved 3 month outcome after stroke. Eligible subjects must be within 12 hours of stroke symptom onset and have diabetes and glucose concentrations of over 110 mg/dL on initial evaluation. The enrolling sites will include the Neurological Emergencies Treatment Trials (NETT) sites as well as non NETT sites from all over the United States. The study will evaluate the safety and efficacy of targeted glucose control (treatment group - IV insulin with target 80-130 mg/dl) verses control therapy of sub q insulin plus basal insulin with target glucose less than 180 mg/ dL. The primary outcome will be functional outcome at 3 months as measured by the modified Rankin Scale (mRS) Score. The primary safety outcome will be severe hypoglycemia defined as <40 mg/dL. Enrollment will occur over 3.5 - 4 years.
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The Stroke, Hyperglycemia Insulin Network Effort (SHINE) Trial is a multicenter, randomized, controlled clinical trial of 1400 patients that will include over 50 enrolling sites. The study hypotheses are that treatment of hyperglycemic acute ischemic stroke patients with targeted glucose concentration (80mg/dL - 130 mg/dL) will be safe and result in improved 3 month outcome after stroke. Eligible subjects must be within 12 hours of stroke symptom onset and have diabetes and glucose concentrations of over 110 mg/dL on initial evaluation. The enrolling sites will include the Neurological Emergencies Treatment Trials (NETT) sites as well as non NETT sites from all over the United States. The study will evaluate the safety and efficacy of targeted glucose control (treatment group - IV insulin with target 80-130 mg/dl) verses control therapy of sub q insulin plus basal insulin with target glucose less than 180 mg/ dL. The primary outcome will be functional outcome at 3 months as measured by the modified Rankin Scale (mRS) Score. The primary safety outcome will be severe hypoglycemia defined as <40 mg/dL. Enrollment will occur over 3.5 - 4 years.
The eligibility criteria were updated.
New
Inclusion Criteria: 1. Age 18 years or older 2. Clinical diagnosis of ischemic stroke defined as acute neurological deficit occurring in one or more cerebral vascular territories. Neuroimaging must be done to exclude intracranial hemorrhage (ICH). 3. Protocol treatment must begin within 3 hours after hospital arrival and within 12 hours after stroke symptom onset. If time of symptom onset is unclear or patient is awakening with stroke symptoms, the time of onset will be the time last known to be well. 4. Known history of type 2 diabetes mellitus and glucose >110 mg/dL OR admission blood glucose ≥150 mg/dL in those w/o known diabetes mellitus 5. Baseline NIHSS score of 3-22 6. Pre-stroke Modified Rankin Scale score = 0 7. Able to provide a valid informed consent to be in the study (self or their authorized legally accepted representative). The approved consent form must be signed and dated in accordance with federal and institutional guidelines. Exclusion Criteria: 1. Known history of type 1 diabetes mellitus 2. Substantial pre-existing neurological or psychiatric illness that would confound the neurological assessment or other outcome assessment 3. Having received experimental therapy for the enrollment stroke. IV tPA (up to 4.5 hrs) or IA tPA are allowed as are IA therapies including use of FDA cleared devices. Non FDA cleared devices are considered experimental and are excluded. 4. Pregnant or breast-feeding at the time of study entry 5. Other serious conditions that make the patient unlikely to survive 90 days 6. Inability to follow the protocol or return for the 90 day follow up 7. Renal dialysis (including hemo or peritoneal dialysis)
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Inclusion Criteria: 1. Age 18 years or older 2. Clinical diagnosis of ischemic stroke defined as acute neurological deficit occurring in one or more cerebral vascular territories. Neuroimaging must be done to exclude intracranial hemorrhage (ICH). 3. Protocol treatment must begin within 3 hours after hospital arrival and within 12 hours after stroke symptom onset. If time of symptom onset is unclear or patient is awakening with stroke symptoms, the time of onset will be the time last known to be well. 4. Known history of type 2 diabetes mellitus and glucose >110 mg/dL OR admission blood glucose ≥150 mg/dL in those w/o known diabetes mellitus 5. Baseline NIHSS score of 3-22 6. Pre-stroke Modified Rankin Scale score = 0 7. Able to provide a valid informed consent to be in the study (self or their authorized legally accepted representative). The approved consent form must be signed and dated in accordance with federal and institutional guidelines. Exclusion Criteria: 1. Known history of type1 diabetes mellitus 2. Substantial pre-existing neurological or psychiatric illness that would confound the neurological assessment or other outcome assessment 3. Having received experimental therapy for the enrollment stroke. Though standard IV tPA or IA tPA are allowed, devices such as MERCI, Penumbra and other unproven interventions are excluded. 4. Pregnant or breast-feeding at the time of study entry 5. Other serious conditions that make the patient unlikely to survive 90 days 6. Inability to follow the protocol or return for the 90 day follow up 7. Renal dialysis
6 Oct '11
The eligibility criteria were updated.
New
Inclusion Criteria: 1. Age 18 years or older 2. Clinical diagnosis of ischemic stroke defined as acute neurological deficit occurring in one or more cerebral vascular territories. Neuroimaging must be done to exclude intracranial hemorrhage (ICH). 3. Protocol treatment must begin within 3 hours after hospital arrival and within 12 hours after stroke symptom onset. If time of symptom onset is unclear or patient is awakening with stroke symptoms, the time of onset will be the time last known to be well. 4. Known history of type 2 diabetes mellitus and glucose >110 mg/dL OR admission blood glucose ≥150 mg/dL in those w/o known diabetes mellitus 5. Baseline NIHSS score of 3-22 6. Pre-stroke Modified Rankin Scale score = 0 7. Able to provide a valid informed consent to be in the study (self or their authorized legally accepted representative). The approved consent form must be signed and dated in accordance with federal and institutional guidelines. Exclusion Criteria: 1. Known history of type1 diabetes mellitus 2. Substantial pre-existing neurological or psychiatric illness that would confound the neurological assessment or other outcome assessment 3. Having received experimental therapy for the enrollment stroke. Though standard IV tPA or IA tPA are allowed, devices such as MERCI, Penumbra and other unproven interventions are excluded. 4. Pregnant or breast-feeding at the time of study entry 5. Other serious conditions that make the patient unlikely to survive 90 days 6. Inability to follow the protocol or return for the 90 day follow up 7. Renal dialysis
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Inclusion Criteria: 1. Age 18 years or older 2. Clinical diagnosis of ischemic stroke defined as acute neurological deficit occurring in one or more cerebral vascular territories. Neuroimaging must be done to exclude intracranial hemorrhage (ICH). 3. Protocol treatment must begin within 3 hours after hospital arrival and within 12 hours after stroke symptom onset. If time of symptom onset is unclear or patient is awakening with stroke symptoms, the time of onset will be the time last known to be well. 4. Known history of type 2 diabetes mellitus and glucose >110 mg/dL OR admission blood glucose ?150 mg/dL in those w/o known diabetes mellitus 5. Baseline NIHSS score of 3-22 6. Pre-stroke Modified Rankin Scale score = 0 7. Able to provide a valid informed consent to be in the study (self or their authorized legally accepted representative). The approved consent form must be signed and dated in accordance with federal and institutional guidelines. Exclusion Criteria: 1. Known history of type1 diabetes mellitus 2. Substantial pre-existing neurological or psychiatric illness that would confound the neurological assessment or other outcome assessment 3. Having received experimental therapy for the enrollment stroke. Though standard IV tPA or IA tPA are allowed, devices such as MERCI, Penumbra and other unproven interventions are excluded. 4. Pregnant or breast-feeding at the time of study entry 5. Other serious conditions that make the patient unlikely to survive 90 days 6. Inability to follow the protocol or return for the 90 day follow up 7. Renal dialysis