Study of Procoagulation Markers in Stroke Patients (I-SPOT)
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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) |
- change in biomarker between patients with favorable versus unfavorable functional outcome [ Time Frame: Randomization, 48 hours and 90 days ] [ Designated as safety issue: No ]
- 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:
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
Subjects will be selected from subjects participating in the SHINE trial.
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 LocationsPlease refer to this study by its ClinicalTrials.gov identifier: NCT01811550
| Contact: Hannah Reimer, RN, BSN | 215-707-5483 | hreimer@temple.edu |
Show 33 Study Locations
| 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 |
ClinicalTrials.gov processed this record on March 03, 2015