Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
271 participants
OBSERVATIONAL
2012-08-31
2019-01-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Hypothesis: The decrease in levels of markers of blood coagulation will be greater in patients treated with IV insulin to reduce BG than in patients treated with SQ Insulin as the standard fashion.
Hypothesis: The decrease in levels of markers of blood coagulation will be greater in patients with than without favorable (SHINE) outcome (defined as the baseline stroke severity adjusted measure of functional ability at 90 days after AIS).
Hypothesis: Hyperglycemia control modulates the relationship between blood coagulation levels and functional outcome in T2DM patients after stroke. Patients treated with IV Insulin for hyperglycemia control with favorable (SHINE) outcome will have greater decreases in blood coagulation levels than either IV Insulin-treated patients without favorable outcome or SQ Insulin-treated with or without favorable outcomes at 90 days after AIS.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
SMARTCap Stroke Study: A Field Deployable Blood Test for Stroke
NCT02308605
Effect of Natalizumab on Infarct Volume in Acute Ischemic Stroke
NCT01955707
Intravenous Thrombolysis Plus Hypothermia for Acute Treatment of Ischemic Stroke
NCT00283088
IMPROVE Stroke Care- Developing and Optimizing Regional Systems of Stroke Care
NCT04242784
Effects of Urinary Kallidinogenase in Acute Ischemic Stroke Patients With Abnormal Glucose Metabolism
NCT04020666
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
COHORT
PROSPECTIVE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
SHINE study subjects
Subjects enrolled in the SHINE trial who are not receiving intra-arterial therapy nor systemic anticoagulation; have no known moderate/severe hepatic insufficiency; have no known history of hypercoaguable or thrombotic condition; have INR =\<1.5 (if known) at baseline and provide informed consent (self or LAR) will be enrolled in the I-SPOT study.
Glycemic Control
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Glycemic Control
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Ability to give Informed Consent (self or LAR)
Exclusion Criteria
* Known moderate or severe hepatic insufficiency (as defined by INR\>1.5 if known or history of variceal bleeding or hepatic encephalopathy)
* Prior or concurrent thrombotic or hypercoagulable condition (Antiphospholipid antibody syndrome; Antithrombin III, Protein C or S deficiencies; Congenital or Inherited Factor deficiencies; sickle cell disease)
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
National Institute of Neurological Disorders and Stroke (NINDS)
NIH
Neurological Emergencies Treatment Trials Network (NETT)
NETWORK
University of Virginia
OTHER
University of Michigan
OTHER
Medical University of South Carolina
OTHER
Augusta University
OTHER
Temple University
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Nina T Gentile, M.D.
Role: PRINCIPAL_INVESTIGATOR
Temple University
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Banner University Medical Center
Tucson, Arizona, United States
Long Beach Memorial Hospital
Long Beach, California, United States
Ronald Regan Medical Center
Los Angeles, California, United States
San Francisco General Hospital
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
Emory University Hospital
Atlanta, Georgia, United States
Grady Memorial Hospital
Atlanta, Georgia, United States
Augusta University
Augusta, Georgia, United States
University of Iowa Hospitals & Clinics
Iowa City, Iowa, United States
University of Kentucky
Lexington, Kentucky, United States
Massachusetts General Hospital
Boston, Massachusetts, United States
Detroit Receiving Hospital
Detroit, Michigan, United States
Sinai-Grace Hospital
Detroit, Michigan, United States
Hennepin County Medical Center
Minneapolis, Minnesota, United States
University of Minnesota Medical Center, Fairview
Minneapolis, Minnesota, United States
Kings County Hospital
Brooklyn, New York, United States
SUNY Downstate University Hospital of Brooklyn
Brooklyn, New York, United States
Kaleida Stroke Center, SUNY Buffalo
Buffalo, New York, United States
Mount Sinai Medical Center
New York, New York, United States
Columbia University Medical Center
New York, New York, United States
Lincoln Medical and Mental Health Center
New York, New York, United States
Summa Health System
Akron, Ohio, United States
University of Cincinnati
Cincinnati, Ohio, United States
Wexner Medical Center
Columbus, Ohio, United States
Abington Memorial Hospital
Abington, Pennsylvania, United States
Hospital of the University of Pennsylvania
Philadelphia, Pennsylvania, United States
Temple University Hospital
Philadelphia, Pennsylvania, United States
UPMC - Mercy
Pittsburgh, Pennsylvania, United States
UPMC - Presbyterian
Pittsburgh, Pennsylvania, United States
UT Southwestern-Parkland Memorial Hospital
Dallas, Texas, United States
UT Southwestern-Zale Lipshy University Hospital
Dallas, Texas, United States
Memorial Hermann Hospital
Houston, Texas, United States
University of Utah
Salt Lake City, Utah, United States
University of Virginia
Charlottesville, Virginia, United States
West Virginia University
Morgantown, West Virginia, United States
Froedtert Memorial Lutheran Hospital
Milwaukee, Wisconsin, United States
Countries
Review the countries where the study has at least one active or historical site.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
11110979
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.