Pilot Study of Pre-Ischemic Conditioning for Intracranial Atherosclerosis (PICASSO)
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|ClinicalTrials.gov Identifier: NCT03208166|
Recruitment Status : Completed
First Posted : July 5, 2017
Results First Posted : October 7, 2019
Last Update Posted : October 7, 2019
|Condition or disease||Intervention/treatment||Phase|
|Intracranial Atherosclerosis||Device: Doctormate Other: Usual Care||Not Applicable|
In this prospective randomized pilot study, 10 eligible high-risk subjects with ICAS will be randomized to RLIC (bilateral upper extremity daily for 30 days) plus medical management (n=5) or medical management alone (n=5). The medical management, which is the standard of care, will be started at study enrollment and continued until close-out in all subjects. It will consist of aspirin 325 mg per day, clopidogrel 75 mg per day, and risk factor management primarily targeting a systolic BP < 140 mmHg and LDL cholesterol < 70 mg /dl.
All subjects will undergo baseline brain arterial spin labeling (ASL) and perfusion MRI to measure CBF and have blood drawn for biomarkers 3-5 days after randomization to allow for washout of any effect from the test RLIC treatment that will be done prior to randomization to determine the subjects' tolerability to RLIC treatment. The period of 3-5 days will provide flexibility for scheduling these tests. After the baseline MRI and biomarker tests are completed, the subjects randomized to RLIC will begin daily RLIC for 30 days. Each daily RLIC treatment will consist of 4 cycles of 5-minute inflations of both blood pressure cuffs simultaneously to a pressure of 200 mm Hg with 5 minutes of reperfusion between each inflation using the Doctormate device.
All subjects will return for their close-out visits 33-35 days after enrolling in the study and will undergo brain ASL and perfusion MRI and have blood drawn for biomarkers at that visit. The study will be conducted at 4 sites (MUSC, MCG, UCLA, USC) to enable us to evaluate the consistency of CBF measurements across multiple sites and to ensure that the recruitment target of 10 subjects will be met in time to allow for the subsequent NIH grant submission in 2017.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||2 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Pilot Study of Pre-Ischemic Conditioning for Intracranial Atherosclerosis|
|Actual Study Start Date :||June 15, 2017|
|Actual Primary Completion Date :||May 30, 2018|
|Actual Study Completion Date :||May 30, 2018|
Experimental: Ischemic Conditioning
Doctormate device is used daily.
Ischemic conditioning device
Other: Usual Care
Standard medical care
Standard medical care.
Other: Usual Care
Standard medical care
- Percent Change in Cerebral Blood Flow (CBF) [ Time Frame: Baseline and 30 days ]Percent change CBF from baseline to 30 days as determined by ASL MRI imaging.
- Change in Putative Blood Biomarkers [ Time Frame: 30 days ]Change in the absolute levels of the following biomarkers will be measured from baseline to 30 days: Nitrite, IL-10, SDF1, Micro RNA 144. Lp-PLA2, IL-6. hsCRP, Soluble E selectin, ICAm, MMP-9, PAI-1,tPA, ADMA
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): NCT03208166
|United States, South Carolina|
|Medical University of South Carolina|
|Charleston, South Carolina, United States, 29403|
|Principal Investigator:||Marc I Chimowitz, MD||Medical University of South Carolina|