Intensive Insulin Therapy With Tight Glycemic Control to Improve Outcomes After Endovascular Therapy for Acute Ischemic Stroke
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|ClinicalTrials.gov Identifier: NCT02054429|
Recruitment Status : Unknown
Verified January 2014 by Adnan H. Siddiqui, University at Buffalo.
Recruitment status was: Recruiting
First Posted : February 4, 2014
Last Update Posted : February 4, 2014
|Condition or disease||Intervention/treatment||Phase|
|Ischemic Stroke||Drug: Insulin||Phase 1|
This will be a prospective open label study of 100 subjects who will be randomized to either an insulin aspart (study drug) infusion (intensive insulin therapy [IIT arm]) for 48hrs or to a control arm. All patients attending the emergency department (ED) of Kaleida health within 24 hrs of symptom onset suggestive of an anterior circulation ischemic stroke will be screened. If they meet the inclusion criteria and do not have any exclusion criteria, informed consent will be obtained and a blinded stratified block randomization process will be initiated.
In addition to receiving endovascular and standard medical therapy for AIS, subjects will be randomized to an intensive insulin treatment arm (IIT arm) or control arm. In the IIT arm subjects will receive an insulin aspart infusion at a minimal rate of 2 units/hr while maintaining blood glucose between 90-120mg/dl for 48 hrs. Glucose control in the control will be at the discretion of the treating provider.
Subjects will have the following study procedures done at different time points: A) assessment of neurological outcomes : modified Rankin scale (mRS) at 30 days and 90 days and NIH stroke scale (NIHSS) at baseline , 24 hrs, 72 hrs, 30 days and 90 days.
B) MRI (Diffusion weighted imaging), 3-5 days and 90 days and C) various plasma and cellular endpoints will be measured in blood collected at baseline, 2, 4, 6, 24 , 48 and 72 hrs and at 30 days and 90 days.
The primary endpoint of the study is to detect a difference in the percentage of non diabetic subjects with mRS 0-2 at 90 days after an AIS treated with endovascular therapy, in the IIT and control arm.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||100 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Study Start Date :||January 2013|
|Estimated Primary Completion Date :||December 2016|
|Estimated Study Completion Date :||December 2018|
IIT arm subjects will receive an insulin aspart infusion at a minimal rate of 2 units/hr while maintaining blood glucose between 90-120mg/dl for 48 hrs
Intensive Insulin Therapy (IIT) will be given to you by two IV infusions. The insulin infusion will be started immediately after you are moved to the intensive care unit (ICU) after endovascular therapy and continued for 48 hours
No Intervention: Standard glycemic control
standard of care if not randomized to Insulin
- Stroke Scale [ Time Frame: 90 days ]modified Rankin Score (specific aim) and NIH stroke scale (exploratory aim)
- MRI [ Time Frame: 2, 3, 5, and 90 days ]Measure infarct volume and determine if there is a reduction in infact volume in the insulin-infused group
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): NCT02054429
|Contact: Jen Gay, B.S.||716-888-4811||Jgay@ubns.com|
|United States, New York|
|University of Buffalo Neurosurgery||Recruiting|
|Buffalo, New York, United States, 14203|
|Principal Investigator: Adnan H Siddiqui, M.D, PhD|