Trial record 2 of 2 for:    SHINE: Stroke Hyperglycemia Insulin Network Effort Trial

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

This study is currently recruiting participants. (see Contacts and Locations)
Verified February 2013 by Temple University
Sponsor:
Collaborators:
SHINE Trial
Neurological Emergencies Treatment Trials Network (NETT)
University of Virginia
University of Michigan
Medical University of South Carolina
Georgia Regents University
Information provided by (Responsible Party):
Temple University
ClinicalTrials.gov Identifier:
NCT01811550
First received: March 12, 2013
Last updated: March 18, 2013
Last verified: February 2013
  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 ] [ Designated as safety issue: No ]

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 ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples With DNA

Whole blood and plasma


Estimated Enrollment: 315
Study Start Date: August 2012
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 recieving thrombolytics 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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Subjects will be selected from subjects participating in the SHINE trial.

Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • Current or anticipated use of systemic anticoagulants or thrombolytics
  • 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
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: NCT01811550

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

  Show 33 Study Locations
Sponsors and Collaborators
Temple University
SHINE Trial
Neurological Emergencies Treatment Trials Network (NETT)
University of Virginia
University of Michigan
Medical University of South Carolina
Georgia Regents University
Investigators
Principal Investigator: Nina T Gentile, M.D. Temple University
  More Information

No publications provided

Responsible Party: Temple University
ClinicalTrials.gov Identifier: NCT01811550     History of Changes
Other Study ID Numbers: 11110979, 1U01NS079077-01A1
Study First Received: March 12, 2013
Last Updated: March 18, 2013
Health Authority: United States: Institutional Review Board
United States: Data and Safety Monitoring Board

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

ClinicalTrials.gov processed this record on September 22, 2014