Study of Procoagulation Markers in Stroke Patients (I-SPOT)
|
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. |
| ClinicalTrials.gov Identifier: NCT01811550 |
|
Recruitment Status
:
Recruiting
First Posted
: March 14, 2013
Last Update Posted
: January 31, 2018
|
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
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 or disease | Intervention/treatment |
|---|---|
| Stroke Hyperglycemia Procoagulation Markers | Other: Glycemic Control |
| Study Type : | Observational |
| Estimated Enrollment : | 315 participants |
| Observational Model: | Cohort |
| Time Perspective: | Prospective |
| Official Title: | Insights on Selected Procoagulation Markers and Outcomes in Stroke Trial (I-SPOT) |
| Study Start Date : | August 2012 |
| Estimated Primary Completion Date : | November 2019 |
| Estimated Study Completion Date : | November 2019 |
| 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:
|
- change in biomarker between patients with favorable versus unfavorable functional outcome [ Time Frame: Randomization, 48 hours and 90 days ]
- 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
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, Learn About Clinical Studies.
| Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
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)
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
| Contact: Hannah Reimer, RN, BSN | 215-707-5483 | hreimer@temple.edu |
Show 40 Study Locations
| Principal Investigator: | Nina T Gentile, M.D. | Temple University |
| Responsible Party: | Temple University |
| ClinicalTrials.gov Identifier: | NCT01811550 History of Changes |
| Other Study ID Numbers: |
11110979 1U01NS079077-01A1 ( U.S. NIH Grant/Contract ) |
| First Posted: | March 14, 2013 Key Record Dates |
| Last Update Posted: | January 31, 2018 |
| Last Verified: | January 2018 |
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 |