Study of Procoagulation Markers in Stroke Patients
I-SPOT
Insights on Selected Procoagulation Markers and Outcomes in Stroke Trial (I-SPOT)
2 other identifiers
observational
271
1 country
38
Brief Summary
The Insights on Selected Procoagulation Markers and Outcomes in Stroke Trial (I-SPOT): Response to Insulin Administration and Blood Glucose Control proposal is designed to accompany the Stroke Hyperglycemia Insulin Network Effort (SHINE) clinical trial, a Phase III multicenter, randomized, controlled trial planning to determine the efficacy and validate the safety of glycemic control in stroke patients. The SHINE trial will recruit 1,400 AIS patients with Type II diabetes mellitus (T2DM) and hyperglycemia, each receiving 3 days of hyperglycemia control with intravenous (IV) insulin therapy or control therapy with subcutaneous (SQ) insulin. The I-SPOT trial will recruit 315 SHINE patients. Blood coagulation marker levels will be measured before and at 48 hours after the start of treatment. Baseline and temporal changes in biomarkers levels will be compared between treatment groups. 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Aug 2012
Longer than P75 for all trials
38 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 1, 2012
CompletedFirst Submitted
Initial submission to the registry
March 12, 2013
CompletedFirst Posted
Study publicly available on registry
March 14, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2019
CompletedApril 30, 2020
April 1, 2020
6.2 years
March 12, 2013
April 29, 2020
Conditions
Outcome Measures
Primary Outcomes (1)
change in biomarker between patients with favorable versus unfavorable functional outcome
Randomization, 48 hours and 90 days
Secondary Outcomes (1)
Changes in biomarker levels between patients with versus without stroke recurrence at 90 days post stroke.
Randomization, 48 hours, 90 days
Study Arms (1)
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.
Interventions
Eligibility Criteria
Subjects will be selected from participants in the SHINE trial.
You may qualify if:
- Enrolled in SHINE study
- Ability to give Informed Consent (self or LAR)
You may not qualify if:
- Current or planned use of full dose anticoagulation from baseline to the 48 hour sample collection
- 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)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Temple Universitylead
- National Institute of Neurological Disorders and Stroke (NINDS)collaborator
- Neurological Emergencies Treatment Trials Network (NETT)collaborator
- University of Virginiacollaborator
- University of Michigancollaborator
- Medical University of South Carolinacollaborator
- Augusta Universitycollaborator
Study Sites (38)
Banner University Medical Center
Tucson, Arizona, 85724, United States
Long Beach Memorial Hospital
Long Beach, California, 90806, United States
Ronald Regan Medical Center
Los Angeles, California, 90095, United States
San Francisco General Hospital
San Francisco, California, 94110, United States
Stanford University Medical Center
Stanford, California, 94305, United States
Medstar Washington Hospital Center
Washington D.C., District of Columbia, 20010, United States
Mayo Clinic Jacksonville
Jacksonville, Florida, 32224, United States
Emory University Hospital
Atlanta, Georgia, 30322, United States
Grady Memorial Hospital
Atlanta, Georgia, 30322, United States
Augusta University
Augusta, Georgia, 30912, United States
University of Iowa Hospitals & Clinics
Iowa City, Iowa, 52242, United States
University of Kentucky
Lexington, Kentucky, 40506, United States
Massachusetts General Hospital
Boston, Massachusetts, 02114, United States
Detroit Receiving Hospital
Detroit, Michigan, 48201, United States
Sinai-Grace Hospital
Detroit, Michigan, 48235, United States
Hennepin County Medical Center
Minneapolis, Minnesota, 55415, United States
University of Minnesota Medical Center, Fairview
Minneapolis, Minnesota, 55455, United States
Kings County Hospital
Brooklyn, New York, 11203, United States
SUNY Downstate University Hospital of Brooklyn
Brooklyn, New York, 11203, United States
Kaleida Stroke Center, SUNY Buffalo
Buffalo, New York, 14210, United States
Mount Sinai Medical Center
New York, New York, 10029, United States
Columbia University Medical Center
New York, New York, 10032, United States
Lincoln Medical and Mental Health Center
New York, New York, 10451, United States
Summa Health System
Akron, Ohio, 44304, United States
University of Cincinnati
Cincinnati, Ohio, 45221, United States
Wexner Medical Center
Columbus, Ohio, 43210, United States
Abington Memorial Hospital
Abington, Pennsylvania, 19001, United States
Hospital of the University of Pennsylvania
Philadelphia, Pennsylvania, 19104, United States
Temple University Hospital
Philadelphia, Pennsylvania, 19140, United States
UPMC - Mercy
Pittsburgh, Pennsylvania, 15219, United States
UPMC - Presbyterian
Pittsburgh, Pennsylvania, 15261, United States
UT Southwestern-Parkland Memorial Hospital
Dallas, Texas, 75390, United States
UT Southwestern-Zale Lipshy University Hospital
Dallas, Texas, 75390, United States
Memorial Hermann Hospital
Houston, Texas, 77030, United States
University of Utah
Salt Lake City, Utah, 84132, United States
University of Virginia
Charlottesville, Virginia, 22908, United States
West Virginia University
Morgantown, West Virginia, 26506, United States
Froedtert Memorial Lutheran Hospital
Milwaukee, Wisconsin, 53226, United States
Biospecimen
Whole blood and plasma
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Nina T Gentile, M.D.
Temple University
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 12, 2013
First Posted
March 14, 2013
Study Start
August 1, 2012
Primary Completion
October 1, 2018
Study Completion
January 1, 2019
Last Updated
April 30, 2020
Record last verified: 2020-04