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

This study is currently recruiting participants.
Verified March 2017 by Temple University
Sponsor:
ClinicalTrials.gov Identifier:
NCT01811550
First Posted: March 14, 2013
Last Update Posted: April 4, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Collaborators:
National Institute of Neurological Disorders and Stroke (NINDS)
Neurological Emergencies Treatment Trials Network (NETT)
University of Virginia
University of Michigan
Medical University of South Carolina
Augusta University
Information provided by (Responsible Party):
Temple University
  Purpose

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.


Condition Intervention
Stroke Hyperglycemia Procoagulation Markers Other: Glycemic Control

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Insights on Selected Procoagulation Markers and Outcomes in Stroke Trial (I-SPOT)

Resource links provided by NLM:


Further study details as provided by Temple University:

Primary Outcome Measures:
  • change in biomarker between patients with favorable versus unfavorable functional outcome [ Time Frame: Randomization, 48 hours and 90 days ]

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

Biospecimen Retention:   Samples With DNA
Whole blood and plasma

Estimated Enrollment: 315
Study Start Date: August 2012
Estimated Study Completion Date: August 2017
Estimated Primary Completion Date: August 2017 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Subjects will be selected from participants in the SHINE trial.
Criteria

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)
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01811550


Contacts
Contact: Hannah Reimer, RN, BSN 215-707-5483 hreimer@temple.edu

  Show 41 Study Locations
Sponsors and Collaborators
Temple University
National Institute of Neurological Disorders and Stroke (NINDS)
Neurological Emergencies Treatment Trials Network (NETT)
University of Virginia
University of Michigan
Medical University of South Carolina
Augusta University
Investigators
Principal Investigator: Nina T Gentile, M.D. Temple University
  More Information

Responsible Party: Temple University
ClinicalTrials.gov Identifier: NCT01811550     History of Changes
Other Study ID Numbers: 11110979
1U01NS079077-01A1 ( U.S. NIH Grant/Contract )
First Submitted: March 12, 2013
First Posted: March 14, 2013
Last Update Posted: April 4, 2017
Last Verified: March 2017

Additional relevant MeSH terms:
Stroke
Hyperglycemia
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Glucose Metabolism Disorders
Metabolic Diseases