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Stroke Hyperglycemia Insulin Network Effort (SHINE) Trial

This study is currently recruiting participants. (see Contacts and Locations)
Verified March 2014 by University of Virginia
Sponsor:
Collaborators:
Neurological Emergencies Treatment Trials Network (NETT)
Medical University of South Carolina
Medical Automation Systems, an Alere Company
Information provided by (Responsible Party):
Karen C. Johnston, University of Virginia
ClinicalTrials.gov Identifier:
NCT01369069
First received: June 6, 2011
Last updated: March 18, 2014
Last verified: March 2014
  Purpose

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.


Condition Intervention Phase
Acute Ischemic Stroke
Diabetes
Hyperglycemia
Drug: IV insulin to maintain target glucose concentration of 80-130 mg/dL
Drug: Standard Care control - sliding scale insulin to keep glucose less than 180 mg/dL
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Stroke Hyperglycemia Insulin Network Effort (SHINE) Trial

Resource links provided by NLM:


Further study details as provided by University of Virginia:

Primary Outcome Measures:
  • modified Rankin Scale Score [ Time Frame: 3 months ] [ Designated as safety issue: No ]
    a 3 month (post stroke) modified Rankin scale score is the primary efficacy outcome measure.

  • Hypoglycemia [ Time Frame: 72 hours ] [ Designated as safety issue: Yes ]
    Severe hypoglycemia (blood glucose < 40mg/dL) is the primary safety outcome and will be measured during the 72 hour treatment period


Estimated Enrollment: 1400
Study Start Date: April 2012
Estimated Study Completion Date: July 2018
Estimated Primary Completion Date: October 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: IV insulin drip with target glucose 80 mg/dL - 130 mg/dL
The intervention arm will have a targeted glucose concentration of 80-130 mg/dL. IV insulin drip will be titrated to keep glucose concentration in this range.
Drug: IV insulin to maintain target glucose concentration of 80-130 mg/dL
Intervention is to keep glucose concentration 80-130 mg/dL for up to 72 hours after randomization. IV insulin drip will be used to maintain glucose target.
Active Comparator: Sub Q insulin to keep glucose less than 180 mg/dL
This standard care arm will get sub q insulin sliding scale to keep glucose concentration less than 180 mg/dL
Drug: Standard Care control - sliding scale insulin to keep glucose less than 180 mg/dL
Sliding scale sub q insulin given will be given up to 4 times per day based on glucose concentration. It will be given only if glucose concentration greater than or equal to 180 mg/dL.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01369069

Contacts
Contact: Karen C Johnston, MD, MSc 434-924-5323 kj4v@virginia.edu
Contact: Amy C Fansler, MPH 434-982-6027 acf7h@virginia.edu

  Hide Study Locations
Locations
United States, Arizona
University of Arizona Recruiting
Tucson, Arizona, United States, 85724
Contact: Kendra Drake, MD       kdrake@neurology.arizona.edu   
Contact: Steve Triponey       striponey@aemrc.arizona.edu   
Principal Investigator: Kendra Drake         
United States, California
Long Beach Memorial Medical Center Recruiting
Long Beach, California, United States, 90806
Contact: Nima Ramezan, MD       nramezan@gmail.com   
Contact: Angie West       AWest@memorialcare.org   
Principal Investigator: Nema Ramezan, MD         
Ronald Regan Medical Center Recruiting
Los Angeles, California, United States, 90095
Contact: Sidney Starkman, MD       starkman@ucla.edu   
Contact: Ileana Grunberg       igrunberg@mednet.ucla.edu   
Principal Investigator: Sidney Starkman, MD         
California Pacific Medical Center - Davies Campus Recruiting
San Francisco, California, United States, 94114
Contact: Nobl Barazangi, MD       BarazaN@sutterhealth.org   
Contact: Katie Ponting       pontink@cpmcri.org   
Principal Investigator: Nobl Barazangi         
California Pacific Medical Center-Pacific Campus Recruiting
San Francisco, California, United States, 94114
Contact: Nobl Barazangi       BarazaN@sutterhealth.org   
Contact: Katie Ponting       pontink@cpmcri.org   
Principal Investigator: Nobl Barazangi, MD         
San Francisco General Hospital Recruiting
San Francisco, California, United States, 94110
Contact: Claude Hemphill, MD       chemphill@sfgh.ucsf.edu   
Contact: Michele Meeker       MeekerM@neurosurg.ucsf.edu   
Principal Investigator: Claude Hemphill, MD         
UCSF Medical Center Recruiting
San Francisco, California, United States, 94117
Contact: Wade Smith, MD       smithw@neurology.ucsf.edu   
Contact: Jun Lauder       lauderi@sfgh.ucsf.edu   
Principal Investigator: Wade Smith, MD         
Stanford University Medical Center Recruiting
Stanford, California, United States, 94305
Contact: Karen Hirsch, MD       khirsch@stanford.edu   
Contact: Rosen Mann       rosen.mann@stanford.edu   
Principal Investigator: Karen Hirsch, MD         
United States, Florida
Mayo Clinic Jacksonville Recruiting
Jacksonville, Florida, United States, 32224
Contact: Kevin M Barrett, MD       Barrett.kevin@mayo.edu   
Contact: Sothear Luke       luke.sothear@mayo.edu   
Principal Investigator: Kevin Barrett, MD         
United States, Georgia
Emory University Hospital Recruiting
Atlanta, Georgia, United States, 30322
Contact: Vishal Patel, MD       vishal.patel@emory.edu   
Contact: Alex Hall       alex.hall@emory.edu   
Principal Investigator: Vishal Patel, MD         
Grady Memorial Hospital Recruiting
Atlanta, Georgia, United States, 30322
Contact: Vishal Patel, MD       vishal.patel@emory.edu   
Contact: Alex Hall       alex.hall@emory.edu   
Principal Investigator: Vishal Patel, MD         
Georgia Regents University Recruiting
Augusta, Georgia, United States, 30912
Contact: Askiel Bruno, MD, MS       abruno@gru.edu   
Contact: Sneha Jacob       SJACOB@gru.edu   
Principal Investigator: Askiel Bruno, MD         
United States, Illinois
OSF Saint Francis Medical Center Recruiting
Peoria, Illinois, United States, 61637
Contact: Deepak Nair, MD       Deepak.Nair@osfhealthcare.org   
Contact: Judith Beck       judith.m.beck@osfhealthcare.org   
Principal Investigator: Deepak Nair, MD         
United States, Kansas
University of Kansas Medical Center Recruiting
Kansas City, Kansas, United States, 66160
Contact: Michael Abraham, MD       MABRAHAM@kumc.edu   
Contact: Shannon Gifford       sgifford@kumc.edu   
Principal Investigator: Michael Abraham, MD         
United States, Kentucky
University of Kentucky Recruiting
Lexington, Kentucky, United States, 40506
Contact: Roger L Humphries, MD       roger.humphries@uky.edu   
Contact: Linda Dechtenberg       ldech3@email.uky.edu   
Principal Investigator: Roger L Humphries, MD         
United States, Maryland
University of Maryland Medical Center Recruiting
Baltimore, Maryland, United States, 21201
Contact: Marcella Wozniak, MD, PhD       MWozniak@som.umaryland.edu   
Contact: Charlene Aldridge       CALDRICH@smail.umaryland.edu   
Principal Investigator: Marcella Wozniak, MD         
United States, Massachusetts
Massachusetts General Hospital Recruiting
Boston, Massachusetts, United States, 02114
Contact: Chris Anderson, MD       cdanderson@partners.org   
Contact: Eric Riklin       eriklin@partners.org   
Principal Investigator: Chris Anderson, MD         
United States, Michigan
University of Michigan Recruiting
Ann Arbor, Michigan, United States, 48109
Contact: Jeffrey Fletcher, MD       jeffletc@med.umich.edu   
Contact: Allie Kade       akade@med.umich.edu   
Principal Investigator: Jeffrey Fletcher, MD         
Detroit Receiving Hospital Recruiting
Detroit, Michigan, United States, 48201
Contact: Gregory Norris, MD       gnorris@med.wayne.edu   
Contact: Valerie Mika       vmika@med.wayne.edu   
Principal Investigator: Gregory Norris, MD         
Henry Ford Health System Recruiting
Detroit, Michigan, United States, 48202
Contact: Chris Lewandowski, MD       clewand1@hfhs.org   
Contact: Anne Marie Lundell       ALUNDEL1@hfhs.org   
Principal Investigator: Chris Lewandowski, MD         
Sinai-Grace Hospital Recruiting
Detroit, Michigan, United States, 48235
Contact: Benjamin Atkinson, MD       pdbhatta@med.wayne.edu   
Contact: Valerie Mika       vmika@med.wayne.edu   
Principal Investigator: Robert Welch, MD         
William Beaumont Hospital-Royal Oak Recruiting
Royal Oak, Michigan, United States, 48073
Contact: Robert Swor, MD       raswor@beaumont.edu   
Contact: Megan Hausler       Megan.Hausler@beaumont.edu   
Principal Investigator: Robert Swor, DO         
William Beaumont Hospital-Troy Recruiting
Troy, Michigan, United States, 48085
Contact: Aveh Bastani, MD       ABastani@beaumont.edu   
Contact: Kristen Palomba       Kristen.Palomba@beaumont.edu   
Principal Investigator: Aveh Bastani, MD         
United States, Minnesota
Hennepin County Medical Center Recruiting
Minneapolis, Minnesota, United States, 55415
Contact: Mustapha Ezzeddine, MD       ezzeddin@umn.edu   
Contact: Julie Scherber       JScherber@yahoo.com   
Principal Investigator: Mustapha Ezzeddine, MD         
University of Minnesota Medical Center, Fairview Recruiting
Minneapolis, Minnesota, United States, 55455
Contact: Mustapha Ezzeddine, MD       ezzeddin@umn.edu   
Contact: Julie Scherber       JScherber@yahoo.com   
Principal Investigator: Mustapha Ezzeddine, MD         
United States, New Jersey
Hackensack University Medical Center Recruiting
Hackensack, New Jersey, United States, 07601
Contact: Joseph Feldman, MD       JFeldman@HackensackUMC.org   
Contact: Gordon Huie       GHuie@HackensackUMC.org   
Principal Investigator: Joseph Feldman, MD         
United States, New York
Lincoln Medical and Mental Health Center Recruiting
Bronx, New York, United States, 10451
Contact: Ragu Loganathan, MD       raghu.loganathan@nychhc.orgte.edu   
Contact: Colette Nyajure       Colette.Nyajure@nychhc.org   
Principal Investigator: Ragu Loganathan, MD         
SUNY Downstate University Hospital of Brooklyn Recruiting
Brooklyn, New York, United States, 11203
Contact: Ethan Brandler, MD       ethan.brandler@downstate.edu   
Contact: Sarah Zelonis       sarah.zelonis@downstate.edu   
Principal Investigator: Ethan Brandler, MD         
Kings County Hospital Recruiting
Brooklyn, New York, United States, 11203
Contact: Jennifer Martindale, MD       martindale.jen@gmail.com   
Contact: Sarah Zelonis       sarah.zelonis@downstate.edu   
Principal Investigator: Jennifer Martindale, MD         
Kaleida Stroke Center, SUNY Buffalo Recruiting
Buffalo, New York, United States, 14210
Contact: Marilou Ching, MD       marilouching@aol.com   
Contact: Anne Marie Crumlish       ac35@buffalo.edu   
Principal Investigator: Marilou Ching, MD         
Weill Cornell Medical Center Active, not recruiting
New York, New York, United States, 10065
Columbia University Medical Center Recruiting
New York, New York, United States, 10032
Contact: Jan Claassen, MD       jc1439@nyp.org   
Contact: Cristina Falo       maf9135@nyp.org   
Principal Investigator: Jan Claassen, MD         
Maimonides Medical Center Recruiting
New York, New York, United States, 11219
Contact: Steven Rudolf, MD       srudolph@maimonidesmed.org   
Contact: Holly Morhaim       hmorhaim@maimonidesmed.org   
Principal Investigator: Steven Rudolf, MD         
United States, Ohio
Summa Akron City Hospital Recruiting
Akron, Ohio, United States, 44307
Contact: Susana Bowling, MD       smbowling@gmail.com   
Contact: Rachelle Scharsu       scharsur@summahealth.org   
Principal Investigator: Susana Bowling, MD         
University of Cincinnati Recruiting
Cincinnati, Ohio, United States, 45221
Contact: Opeolu Adeoye, MD       adeoyeo@ucmail.uc.edu   
Contact: Irene Ewing       ewingi@ucmail.uc.edu   
Principal Investigator: Opeolu Adeoye, MD         
Wexner Medical Center Recruiting
Columbus, Ohio, United States, 43210
Contact: Michel Torbey, MD       Michel.Torbey@osumc.edu   
Contact: April Spangler       April.Spangler@osumc.edu   
Principal Investigator: Michel Torbey, MD         
United States, Pennsylvania
Abington Memorial Hospital Recruiting
Abington, Pennsylvania, United States, 19001
Contact: David Weisman, MD       dcweisman@gmail.com   
Contact: Ally Blue Schaller       ablueschaller@gmail.com   
Principal Investigator: David Weisman, MD         
Penn State Hershey Medical Center Recruiting
Hershey, Pennsylvania, United States, 17033
Contact: Kerstin Bettermann, MD       kbettermann@hmc.psu.edu   
Contact: Deborah Hoffman       dhoffman1@hmc.psu.edu   
Principal Investigator: Kerstin Bettermann, MD         
Temple University Hospital Recruiting
Philadelphia, Pennsylvania, United States, 19140
Contact: Nina Gentile, MD       ngentile@temple.edu   
Contact: Brent Freeman       freemanb@temple.edu   
Principal Investigator: Nina Gentile, MD         
Jefferson Hospital Recruiting
Philadelphia, Pennsylvania, United States, 19102
Contact: Jacqueline Urtecho, MD       Jacqueline.Urtecho@jefferson.edu   
Contact: Amanda Salvatore       amanda.salvatore@jefferson.edu   
Principal Investigator: Jacqueline Urtecho, MD         
Hospital of the University of Pennsylvania Recruiting
Philadelphia, Pennsylvania, United States, 19104
Contact: Brett Cucchiara, MD       brett.cucchiara@uphs.upenn.edu   
Contact: Melissa Kruszewski       ssa.kruszewski@uphs.upenn.edu   
Principal Investigator: Brett Cucchiara, MD         
UPMC - Mercy Recruiting
Pittsburgh, Pennsylvania, United States, 15219
Contact: Lori Shutter, MD       shutterla@upmc.edu   
Contact: Sara Vandruff       vandruffsm@upmc.edu   
Principal Investigator: Lori Shutter, MD         
UPMC Presbyterian Recruiting
Pittsburgh, Pennsylvania, United States, 15213
Contact: Lori Shutter, MD       shutterla@upmc.edu   
Contact: Sara DiFiore       vandruffsm@upmc.edu   
Principal Investigator: Clifton Callaway, MD         
United States, Tennessee
Vanderbilt University Medical Center Recruiting
Nashville, Tennessee, United States, 37232
Contact: Howard Kirschner, MD       howard.kirshner@Vanderbilt.Edu   
Contact: Diane Brown       diane.brown@Vanderbilt.Edu   
Principal Investigator: Howard Kirshner, MD         
United States, Texas
University Medical Center Brackenridge, Austin, TX Recruiting
Austin, Texas, United States, 78701
Contact: Steven Warach, MD       SWarach@seton.org   
Contact: Heidi Tyler       HTyler@seton.org   
Principal Investigator: Steven Warach, MD         
Seton Medical Center Recruiting
Austin, Texas, United States, 78705
Contact: Steven Warach, MD       SWarach@seton.org   
Contact: Heidi Tyler       HTyler@seton.org   
Principal Investigator: Steven Warach, MD         
UT Southwestern Recruiting
Dallas, Texas, United States, 75390
Contact: Christiana Hall, MD, MS       Christiana.Hall@utsouthwestern.edu   
Contact: Katrina van de Bruinhorst       Katrina.vandebruinhorst@utsouthwestern.edu   
Principal Investigator: Christiana Hall, MD, MS         
Valley Baptist Medical Center Recruiting
Harlingen, Texas, United States, 78552
Contact: Ameer Hasaan, MD       ameerh@aol.com   
Contact: Oliver Sanchez       olive.sanchez@valleybaptist.net   
Principal Investigator: Ameer Hassan, MD         
Memorial Herman Hospital Recruiting
Houston, Texas, United States, 77030
Contact: Elizabeth Jones, MD       elizabeth.b.jones@uth.tmc.edu   
Contact: Misty Ottman       misty.ottman@uth.tmc.edu   
Principal Investigator: Elizabeth Jones, MD         
Baylor College of Medicine Recruiting
Houston, Texas, United States, 77030
Contact: Jose Suarez, MD       jisuarez@bcm.edu   
Contact: Eusebia Calvillo       eusebiac@bcm.edu   
Principal Investigator: Jose I Suarez, MD         
United States, Utah
University of Utah Recruiting
Salt Lake City, Utah, United States, 84132
Contact: Jana Wold, MD       jana.wold@hsc.utah.edu   
Contact: Suyi Niu       SUYI.NIU@hsc.utah.edu   
Principal Investigator: Jana Wold, MD         
United States, Virginia
University of Virginia Recruiting
Charlottesville, Virginia, United States, 22908
Contact: Karen C Johnston, MD, MSc       kj4v@virginia.edu   
Contact: Amy C Fansler, MPH       acf7h@virginia.edu   
Principal Investigator: Karen C Johnston, MD, MSc         
Virginia Commonwealth University Active, not recruiting
Richmond, Virginia, United States, 23298
United States, Washington
Harborview Medical Center Recruiting
Seattle, Washington, United States, 98104
Contact: David Tirschwell, MD       tirsch@uw.edu   
Contact: Glenn Schubert       gbs61@u.washington.edu   
Principal Investigator: David Tirschwell, MD         
United States, West Virginia
West Virginia University Recruiting
Morgantown, West Virginia, United States, 26506
Contact: Todd Crocco, MD       tcrocco@hsc.wvu.edu   
Contact: Jay Sherman       shermanj@wvuhealthcare.com   
Principal Investigator: Todd Crocco, MD         
United States, Wisconsin
Froedtert Memorial Hospital Recruiting
Milwaukee, Wisconsin, United States, 53226
Contact: John Lynch, MD       jlynch@mcw.edu   
Contact: Samantha Gauger       sgauger@mcw.edu   
Principal Investigator: John Lynch, MD         
Sponsors and Collaborators
University of Virginia
Neurological Emergencies Treatment Trials Network (NETT)
Medical University of South Carolina
Medical Automation Systems, an Alere Company
Investigators
Study Chair: Karen C Johnston, MD, MSc University of Virginia
Principal Investigator: Christiana Hall, MD, MS UT Southwestern
Principal Investigator: Askiel Bruno, MD, MS Georgia Regents University
Principal Investigator: Valerie Durkalski, PhD Medical University of South Carolina
Principal Investigator: William Barsan, MD University of Michigan
  More Information

Additional Information:
No publications provided by University of Virginia

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Karen C. Johnston, Principal Investigator, University of Virginia
ClinicalTrials.gov Identifier: NCT01369069     History of Changes
Other Study ID Numbers: 15959, U01NS069498
Study First Received: June 6, 2011
Last Updated: March 18, 2014
Health Authority: United States: Federal Government
United States: Institutional Review Board

Keywords provided by University of Virginia:
stroke
diabetes
hyperglycemia

Additional relevant MeSH terms:
Cerebral Infarction
Hyperglycemia
Stroke
Brain Diseases
Brain Infarction
Brain Ischemia
Cardiovascular Diseases
Central Nervous System Diseases
Cerebrovascular Disorders
Glucose Metabolism Disorders
Metabolic Diseases
Nervous System Diseases
Vascular Diseases
Insulin
Insulin, Globin Zinc
Hypoglycemic Agents
Pharmacologic Actions
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on November 25, 2014