Effect of Remote Ischemic Conditioning on Vascular Health in Stroke Patients
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- University of Copenhagen
- Enrollment
- 30
- Locations
- 2
- Primary Endpoint
- Flow mediated dilation
Study Overview
Brief Summary
The main aim of the current study is to assess cardiovascular effects of remote ischemic conditioning in patients who have suffered from stroke. A group of stroke patients will be subjected to four weeks of daily remote ischemic conditioning and four weeks of placebo and vascular function is assessed as a primary outcome.
Detailed Description
Remote ischemic preconditioning (RIC) has been shown to reduce myocardial damage in association with a myocardial infarct but less is known about the potential effects on vascular function in patients who have suffered a stroke. RIC is a procedure by which blood flow to a limb is repeatedly occluded during a short period by an inflatable cuff. This project evaluates the effect of a two week period with RIC on vascular function and cerebral blood flow velocity as well as on factors associated with blood clot formation in patients who have suffered a stroke. The study also aims to provide mechanistic insight into the beneficial effects of the RIC procedure.
Subjects are patients who within the past five years have suffered from lacunar infarct. The study is of a cross-over design with two weeks of homebased RIC treatment and two weeks of control period in a randomized order. Before and after the experimental periods the subjects undergo a number of tests assessing general health status, vascular function and cerebral blood flow velocity. Skeletal muscle samples are obtained for the determination of selected proteins related to vascular function and angiogenesis and blood samples are obtained for the determination of platelet function.
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Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Crossover
- Primary Purpose
- Basic Science
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Clinical symptoms and corresponding computer tomographytomography/magnetic resonance (CT/MR)-scanning results for lacunar infarct within past five years.
- •Small vessel disease stroke (lacunar infarct) is defined by the TOAST criteria
Exclusion Criteria
- •Clinical significant carotid stenosis. Cardioembolic stroke
- •Clinically significant chronic diseases other than lacunar infarct and associated factors
- •Current or past smoker within the past ten years
- •Current treatment with beta-blockers, peroral steroids or NSAIDS
- •Alcohol- or drug-addiction.
- •Pregnant or lactating.
- •Inability to understand the content of the study information provided.
Arms & Interventions
Remote ischemic conditioning
The participant will conduct remote ischemic preconditioning by use of an automated cuff device placed on the upper arm which inflates to 200 mmHg and occludes blood flow. The procedure is conducted on one arm 4 x 5 min per day. Each 5 min occlusion period is interspersed by 5 min.
Intervention: Remote ischemic conditioning (Procedure)
Sham occlusion
The participant will conduct a sham procedure of remote ischemic preconditioning by use of an automated cuff device placed on the upper arm which inflates minimally and does not occlude blood flow. The procedure is conducted on one arm 4 x 5 min per day. Each 5 min of sham occlusion is interspersed by 5 min.
Intervention: Remote ischemic conditioning (Procedure)
Outcomes
Primary Outcomes
Flow mediated dilation
Time Frame: Change from baseline to 4 weeks
Assessment of brachial artery dilation after 5 min occlusion of upper arm by cuff
Secondary Outcomes
- Plasma lipids(Change from baseline to 4 weeks)
- Oral glucose tolerance test (OGTT)(Change from baseline to 4 weeks)
- Skeletal muscle blood flow(Change from baseline to 4 weeks)
- Blood clot structure-gel point(Change from baseline to 4 weeks)
- Blood clot structure-fractal analysis(Change from baseline to 4 weeks)
- Platelet reactivity(Change from baseline to 4 weeks)
- Skeletal muscle proteins(Change from baseline to 4 weeks)
- Plasma proteins(Change from baseline to 4 weeks)
- Cerebral vascular function-visual task(Change from baseline to 4 weeks)
- Cerebral vascular function- motorparadigm task(Change from baseline to 4 weeks)
- Body composition(Change from baseline to 4 weeks)
Investigators
Ylva Hellsten
Professor
University of Copenhagen