Study of Procoagulation Markers in Stroke Patients (I-SPOT)

April 29, 2020 updated by: Temple University

Insights on Selected Procoagulation Markers and Outcomes in Stroke Trial (I-SPOT)

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

271

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Arizona
      • Tucson, Arizona, United States, 85724
        • Banner University Medical Center
    • California
      • Long Beach, California, United States, 90806
        • Long Beach Memorial Hospital
      • Los Angeles, California, United States, 90095
        • Ronald Regan Medical Center
      • San Francisco, California, United States, 94110
        • San Francisco General Hospital
      • Stanford, California, United States, 94305
        • Stanford University Medical Center
    • District of Columbia
      • Washington, District of Columbia, United States, 20010
        • Medstar Washington Hospital Center
    • Florida
      • Jacksonville, Florida, United States, 32224
        • Mayo Clinic Jacksonville
    • Georgia
      • Atlanta, Georgia, United States, 30322
        • Emory University Hospital
      • Atlanta, Georgia, United States, 30322
        • Grady Memorial Hospital
      • Augusta, Georgia, United States, 30912
        • Augusta University
    • Iowa
      • Iowa City, Iowa, United States, 52242
        • University of Iowa Hospitals & Clinics
    • Kentucky
      • Lexington, Kentucky, United States, 40506
        • University of Kentucky
    • Massachusetts
      • Boston, Massachusetts, United States, 02114
        • Massachusetts General Hospital
    • Michigan
      • Detroit, Michigan, United States, 48201
        • Detroit Receiving Hospital
      • Detroit, Michigan, United States, 48235
        • Sinai-Grace Hospital
    • Minnesota
      • Minneapolis, Minnesota, United States, 55415
        • Hennepin County Medical Center
      • Minneapolis, Minnesota, United States, 55455
        • University of Minnesota Medical Center, Fairview
    • New York
      • Brooklyn, New York, United States, 11203
        • Kings County Hospital
      • Brooklyn, New York, United States, 11203
        • SUNY Downstate University Hospital of Brooklyn
      • Buffalo, New York, United States, 14210
        • Kaleida Stroke Center, SUNY Buffalo
      • New York, New York, United States, 10032
        • Columbia University Medical Center
      • New York, New York, United States, 10029
        • Mount Sinai Medical Center
      • New York, New York, United States, 10451
        • Lincoln Medical and Mental Health Center
    • Ohio
      • Akron, Ohio, United States, 44304
        • Summa Health System
      • Cincinnati, Ohio, United States, 45221
        • University of Cincinnati
      • Columbus, Ohio, United States, 43210
        • Wexner Medical Center
    • Pennsylvania
      • Abington, Pennsylvania, United States, 19001
        • Abington Memorial Hospital
      • Philadelphia, Pennsylvania, United States, 19104
        • Hospital of the University of Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19140
        • Temple University Hospital
      • Pittsburgh, Pennsylvania, United States, 15219
        • UPMC - Mercy
      • Pittsburgh, Pennsylvania, United States, 15261
        • UPMC - Presbyterian
    • Texas
      • Dallas, Texas, United States, 75390
        • UT Southwestern-Parkland Memorial Hospital
      • Dallas, Texas, United States, 75390
        • UT Southwestern-Zale Lipshy University Hospital
      • Houston, Texas, United States, 77030
        • Memorial Hermann Hospital
    • Utah
      • Salt Lake City, Utah, United States, 84132
        • University of Utah
    • Virginia
      • Charlottesville, Virginia, United States, 22908
        • University of Virginia
    • West Virginia
      • Morgantown, West Virginia, United States, 26506
        • West Virginia University
    • Wisconsin
      • Milwaukee, Wisconsin, United States, 53226
        • Froedtert Memorial Lutheran Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Subjects will be selected from participants in the SHINE trial.

Description

Inclusion Criteria:

  • Enrolled in SHINE study
  • Ability to give Informed Consent (self or LAR)

Exclusion Criteria:

  • 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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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.
Other: Glycemic Control
Other Names:
  • Blood draw at 0 and 48 hours
  • Glycemic Control per SHINE protocol

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
change in biomarker between patients with favorable versus unfavorable functional outcome
Time Frame: Randomization, 48 hours and 90 days
Randomization, 48 hours and 90 days

Secondary Outcome Measures

Outcome Measure
Time Frame
Changes in biomarker levels between patients with versus without stroke recurrence at 90 days post stroke.
Time Frame: Randomization, 48 hours, 90 days
Randomization, 48 hours, 90 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Temple University

Collaborators

Medical University of South Carolina
National Institute of Neurological Disorders and Stroke (NINDS)
University of Michigan
Augusta University
University of Virginia
Neurological Emergencies Treatment Trials Network (NETT)

Investigators

  • Principal Investigator: Nina T Gentile, M.D., Temple University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2012

Primary Completion (Actual)

October 1, 2018

Study Completion (Actual)

January 1, 2019

Study Registration Dates

First Submitted

March 12, 2013

First Submitted That Met QC Criteria

March 12, 2013

First Posted (Estimate)

March 14, 2013

Study Record Updates

Last Update Posted (Actual)

April 30, 2020

Last Update Submitted That Met QC Criteria

April 29, 2020

Last Verified

April 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 11110979
  • 1U01NS079077-01A1 (U.S. NIH Grant/Contract)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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