Ignite Creation Date:
2025-12-24 @ 4:27 PM
Ignite Modification Date:
2026-02-25 @ 7:27 PM
Study NCT ID:
NCT03208166
Status:
COMPLETED
Last Update Posted:
2019-10-07
First Post:
2017-06-30
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Pilot Study of Pre-Ischemic Conditioning for Intracranial Atherosclerosis
Sponsor:
Medical University of South Carolina
Organization:
Study Overview
Official Title:
Pilot Study of Pre-Ischemic Conditioning for Intracranial Atherosclerosis
Status:
COMPLETED
Status Verified Date:
2019-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
PICASSO
Brief Summary:
The purpose of this study is to determine the effects of the Doctormate device, a specialized blood pressure cuff used to perform remote limb ischemic conditioning, on cerebral blood flow in subjects with intracranial atherosclerosis. Previous studies in patients with narrowing of the brain arteries have shown that this device is safe to use and suggested that if this device is inflated in both arms for 5 minutes, followed by deflation for 5 minutes and repeated 4 times in a row every day for 6-9 months, the risk of another stroke is lowered and the device may increase the blood flow to the brain.
Detailed Description:
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.
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 Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: