Stroke Hyperglycemia Insulin Network Effort (SHINE) Trial

Completed · Phase 3

Conditions studied: Acute Ischemic Stroke, Diabetes, Hyperglycemia

In brief

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.

Key facts

Study ID

NCT01369069

Run by

University of Virginia

People needed

1151

Starts

2012-04-01

Expected to finish

2018-11-19

Last updated by the study team

2019-12-23

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Age 18 years or older
• 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).
• 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.
• 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
• Baseline NIHSS score of 3-22
• 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.
• 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.

You may not qualify if…

• Known history of type 1 diabetes mellitus
• Substantial pre-existing neurological or psychiatric illness that would confound the neurological assessment or other outcome assessment
• 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.
• Pregnant or breast-feeding at the time of study entry
• Other serious conditions that make the patient unlikely to survive 90 days
• Inability to follow the protocol or return for the 90 day follow up
• Renal dialysis (including hemo or peritoneal dialysis)

Where it is running

• University of Arizona — Tucson, Arizona, United States
• Long Beach Memorial Medical Center — Long Beach, California, United States
• Ronald Regan Medical Center — Los Angeles, California, United States
• San Francisco General Hospital — San Francisco, California, United States
• California Pacific Medical Center - Davies Campus — San Francisco, California, United States
• California Pacific Medical Center-Pacific Campus — San Francisco, California, United States
• UCSF Medical Center — San Francisco, California, United States
• Stanford University Medical Center — Stanford, California, United States
• MedStar Washington Hospital Center — Washington D.C., District of Columbia, United States
• Mayo Clinic Jacksonville — Jacksonville, Florida, United States
• Jackson Memorial Hospital — Miami, Florida, United States
• Emory University Hospital - Midtown — Atlanta, Georgia, United States
• Emory University Hospital — Atlanta, Georgia, United States
• Grady Memorial Hospital — Atlanta, Georgia, United States
• Augusta University Medical Center — Augusta, Georgia, United States
• Northwestern Memorial Hospital — Chicago, Illinois, United States
• OSF Saint Francis Medical Center — Peoria, Illinois, United States
• University of Iowa Hospitals & Clinics — Iowa City, Iowa, United States
• University of Kansas Medical Center — Kansas City, Kansas, United States
• University of Kentucky — Lexington, Kentucky, United States
• University of Maryland Medical Center — Baltimore, Maryland, United States
• Tufts Medical Center — Boston, Massachusetts, United States
• Massachusetts General Hospital — Boston, Massachusetts, United States
• University of Michigan — Ann Arbor, Michigan, United States
• University of Arizona Medical Center - South Campus — Tucson, Arizona, United States

Full record on ClinicalTrials.gov

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