Stroke Hyperglycemia Insulin Network Effort (SHINE) Trial



Status:Active, not recruiting
Conditions:Neurology, Diabetes
Therapuetic Areas:Endocrinology, Neurology
Healthy:No
Age Range:18 - Any
Updated:9/2/2018
Start Date:April 2012
End Date:December 2018

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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 randomized within 12 hours of stroke symptom onset and either have
type 2 diabetes and glucose concentrations of over 110 mg/dL or no history of diabetes and
glucose concentrations of 150 mg/dL or higher 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 5-7 years.


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. Randomization must be within 12 hours after stroke symptom onset and treatment 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)
We found this trial at
70
sites
1364 Clifton Rd NE
Atlanta, Georgia 30322
(404) 712-2000
Principal Investigator: Vishal Patel, MD
Emory University Hospital As the largest health care system in Georgia and the only health...
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185 Cambridge Street
Boston, Massachusetts 02114
617-724-5200
Principal Investigator: Chris Anderson, MD
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Boston, MA
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800 Washington St
Boston, Massachusetts 02111
(617) 636-5000
Tufts Medical Center Tufts Medical Center is an internationally-respected academic medical center – a teaching...
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Boston, MA
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6071 West Outer Drive
Detroit, Michigan 48235
Principal Investigator: Wazim Mohamed, MD
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Detroit, MI
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1200 Moursund Street
Houston, Texas 77030
(713) 798-4951
Principal Investigator: Chethan I Rao, MD
Baylor College of Medicine Baylor College of Medicine in Houston, the only private medical school...
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1500 Northwest 12th Avenue # 106
Miami, Florida 33136
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1211 Medical Center Dr
Nashville, Tennessee 37232
(615) 322-5000
Vanderbilt Univ Med Ctr Vanderbilt University Medical Center (VUMC) is a comprehensive healthcare facility dedicated...
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1 Gustave L Levy Pl # 271
New York, New York 10029
 (212) 241-6500
Mount Sinai Med Ctr Founded in 1852, The Mount Sinai Hospital is a 1,171-bed, tertiary-care...
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New York, NY
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3400 Spruce St
Philadelphia, Pennsylvania 19104
 (215) 662-4000
Principal Investigator: Brett Cucchiara, MD
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201 Presidents Circle
Salt Lake City, Utah 84108
801) 581-7200
Principal Investigator: Jana Wold, MD
University of Utah Research is a major component in the life of the U benefiting...
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1200 Old York Road
Abington, Pennsylvania 19001
(215) 481–2000
Principal Investigator: David Weisman, MD
Abington Memorial Hospital Abington Memorial Hospital (AMH) is a 665-bed, regional referral center and teaching...
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525 E Market St
Akron, Ohio 44304
(330) 375-3000
Principal Investigator: Susana Bowling, MD
Summa Akron City Hospital Summa Akron City Hospital was founded in 1892 to provide a...
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500 S State St
Ann Arbor, Michigan 48109
(734) 764-1817
Principal Investigator: Kyle Sheehan, MD
University of Michigan The University of Michigan was founded in 1817 as one of the...
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550 Peachtree St NE
Atlanta, Georgia 30308
(404) 686-4411
Emory University Hospital Midtown Emory University Hospital Midtown is a 511-bed community-based, acute care teaching...
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80 Jesse Hill Jr Dr SE
Atlanta, Georgia 30303
(404) 616-1000
Principal Investigator: Vishal Patel, MD
Grady Memorial Hospital Grady is an internationally recognized teaching hospital staffed exclusively by doctors from...
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Augusta, Georgia 30912
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Austin, Texas 78705
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Austin, Texas 78701
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22 S Greene St
Baltimore, Maryland 21201
(410) 328-8667
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Brooklyn, New York 11203
Principal Investigator: Susan Law, MD
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Brooklyn, New York 11203
Principal Investigator: Steven Levine, MD
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Buffalo, New York 14203
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Charlottesville, Virginia 22903
(434) 924-0311
Principal Investigator: Karen C Johnston, MD, MSc
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251 E Huron St
Chicago, Illinois 60611
(312) 926-2000
Principal Investigator: Shyam Prabhakaran, MD
Northwestern Memorial Hospital Northwestern Memorial is an academic medical center hospital where the patient comes...
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2600 Clifton Ave
Cincinnati, Ohio 45267
(513) 556-6000
Principal Investigator: Opeolu Adeoye, MD
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Columbus, Ohio 43210
Principal Investigator: Michel Torbey, MD
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Dallas, Texas 75390
Principal Investigator: Christiana Hall, MD, MS
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Dallas, Texas 75390
Principal Investigator: Christiana Hall, MD, MS
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1 Wyoming St,
Dayton, Ohio 45409
(937) 208-8000
Miami Valley Hospital Miami Valley Hospital (MVH) is passionate about providing the most recent medical...
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Detroit, Michigan 48202
Principal Investigator: Wazim MOHAMED, MD
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Detroit, Michigan 48202
Principal Investigator: Chris Lewandowski, MD
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Edison, New Jersey
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30 Prospect Ave
Hackensack, New Jersey 07601
(201) 996-2000
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Harlingen, Texas 78550
Principal Investigator: Ameer Hassan, MD
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Hershey, Pennsylvania 17033
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Houston, Texas 77030
Principal Investigator: Elizabeth Jones, MD
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200 Hawkins Dr,
Iowa City, Iowa 52242
866-452-8507
University of Iowa Hospitals and Clinics University of Iowa Hospitals and Clinics—recognized as one of...
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Jacksonville, Florida 32216
Principal Investigator: Kevin Barrett, MD
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3901 Rainbow Blvd
Kansas City, Kansas 66160
(913) 588-5000
University of Kansas Medical Center The University of Kansas Medical Center serves Kansas through excellence...
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Lexington, Kentucky
859) 257-9000
Principal Investigator: Roger L Humphries, MD
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Long Beach, California 90801
Principal Investigator: Nema Ramezan, MD
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Los Angeles, California 90095
Principal Investigator: Sidney Starkman, MD
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Milwaukee, Wisconsin
Principal Investigator: John Lynch, MD
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Minneapolis, Minnesota 55414
Principal Investigator: Michelle BIROS, MD
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2450 Riverside Ave
Minneapolis, Minnesota 55454
(612) 273-3000
Principal Investigator: Mustapha Ezzeddine, MD
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Morgantown, West Virginia 26506
(304) 293-0111
Principal Investigator: Todd Crocco, MD
West Virginia University West Virginia University, founded in 1867, has a long and rich history...
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Nashville, Tennessee 37205
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New York, New York 10065
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New York, New York 11219
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630 W 168th St
New York, New York
212-305-2862
Principal Investigator: Jan Claassen, MD
Columbia University Medical Center Situated on a 20-acre campus in Northern Manhattan and accounting for...
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Peoria, Illinois 61637
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3401 N Broad St
Philadelphia, Pennsylvania
(215) 707-2000
Principal Investigator: Nina Gentile, MD
Temple University Hospital On January 18, 1892 a three-story house at 3403 North Broad Street...
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111 S 11th St
Philadelphia, Pennsylvania 19107
(215) 955-6000
Thomas Jefferson University Hospital Our hospitals in Center City Philadelphia share a 13-acre campus with...
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Pittsburgh, Pennsylvania 15213
Principal Investigator: Clifton Callaway, MD
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Pittsburgh, Pennsylvania 15219
Principal Investigator: Lori Shutter, MD
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320 E North Ave
Pittsburgh, Pennsylvania 15212
(412) 359-3131
Allegheny General Hospital At Allegheny General Hospital, our physicians and healthcare staff have earned an...
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Richmond, Virginia 23298
(804) 828-0100
Virginia Commonwealth University Since our founding as a medical school in 1838, Virginia Commonwealth University...
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3601 W 13 Mile Rd
Royal Oak, Michigan 48073
(248) 898-5000
William Beaumont Hospital-Royal Oak The largest Beaumont Hospital is located at 3601 W Thirteen Mile...
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1001 Potrero Ave
San Francisco, California 94110
(415) 206-8000
San Francisco General Hospital San Francisco General Hospital and Trauma Center (SFGH) is an essential...
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San Francisco, California 94114
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San Francisco, California 94114
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San Francisco, California 94115
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325 9th Ave
Seattle, Washington 98104
(206) 744-3300
Harborview Medical Center Harborview Medical Center is the only designated Level 1 adult and pediatric...
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300 Pasteur Dr
Stanford, California 94305
(650) 723-4000
Principal Investigator: Karen Hirsch, MD
Stanford Univ Med Ctr The Medical Center is uniquely advantaged by its location on the...
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44201 Dequindre Rd
Troy, Michigan 48085
(248) 964-5000
William Beaumont Hospital, Troy Beaumont Hospital, Troy campus is a 458-bed community hospital with full...
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Tucson, Arizona 85721
(520) 621-2211
University of Arizona The University of Arizona is a premier, public research university. Established in...
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Tucson, Arizona 85713
Principal Investigator: Kendra Drake, MD
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Washington, District of Columbia
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York, Pennsylvania 17403
Principal Investigator: Brent Becker, MD
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