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Remote Ischemic Preconditioning for Brain Aneurysm
N/A
Waitlist Available
Led By Robert Starke, M.D.
Research Sponsored by Sebastian Koch
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, 3-9 months.
Awards & highlights
Study Summary
This trial is testing a possible way to protect the brain from low blood flow by reducing blood flow to an arm or leg for a short time. The study will enroll 50 patients and compare the effects of the treatment to a sham group.
Eligible Conditions
- Unruptured Cerebral Aneurysm
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline, 3-9 months.
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, 3-9 months.
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Incidence of all adverse events and serious adverse events.
Secondary outcome measures
Change in procedurally-induced vascular cognitive impairment.
Frequency of large (>10 cc value) strokes.
Volume of embolic strokes by Diffusion Weighted Imaging (DWI).
+1 moreTrial Design
2Treatment groups
Experimental Treatment
Placebo Group
Group I: Treatment group: standard blood pressure cuffExperimental Treatment1 Intervention
A standard blood pressure cuff inflated on the participants arm for 4 cycles; each cycle will include 5 minutes of inflation followed by 5 minutes of deflection. RIPC will be applied via a standard blood pressure cuff. The ischemic cycle will involve cuff inflating to 30mmHg above resting systolic blood pressure and demonstration of loss of radial pulse.
Group II: Sham group: standard blood pressure cuffPlacebo Group1 Intervention
The blood pressure cuff will be inflated to 30mmHg during the first 5 minutes of each cycle and deflated for the following 5 minutes, with re-demonstration of radial pulse. This will be repeated for 4 cycles.
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Who is running the clinical trial?
Sebastian KochLead Sponsor
Sebastian Koch, MDStudy DirectorUniversity of Miami
2 Previous Clinical Trials
74 Total Patients Enrolled
Robert Starke, M.D.Principal InvestigatorUniversity of Miami
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You have a certain type of brain aneurysm that may not be eligible, unless a specific treatment is planned to exclude the aneurysm from the circulation.You cannot have an MRI scan for any reason.You have taken part in a research study testing a new drug in the last 30 days. You have also been in a study related to blood flow problems or have received a certain type of treatment called RIPC before.Your top blood pressure number is higher than 200.You have certain medical devices or conditions in your arm that could affect the study.You have HIV.You cannot handle having a tight band around your arm like a blood pressure cuff.You have a brain aneurysm that can be treated using certain methods involving coils, stents, or other devices.You have not had any recent symptoms of a blockage in your blood vessels in the brain.You have a soft tissue, bone, or blood vessel injury that would make it difficult for you to do a certain type of treatment for your arm.You have a history of blood clot in your arm or a condition called peripheral vascular disease.You are planning to treat the aneurysm by blocking the blood vessel.You have a serious mental health condition that would make it hard for you to follow the study's plan.You had a disability before the study that didn't make it hard for you to do an MRI or cognitive tests.You have had a serious head injury that would prevent you from completing the study or having MRI scans to look for small strokes.
Research Study Groups:
This trial has the following groups:- Group 1: Sham group: standard blood pressure cuff
- Group 2: Treatment group: standard blood pressure cuff
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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