Effect of Remote Ischemic Conditioning on Vascular Health in Stroke Patients
- Conditions
- Stroke, Lacunar
- Registration Number
- NCT03635177
- Lead Sponsor
- University of Copenhagen
- 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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Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 30
- 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
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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Primary Outcome Measures
Name Time Method Flow mediated dilation Change from baseline to 4 weeks Assessment of brachial artery dilation after 5 min occlusion of upper arm by cuff
- Secondary Outcome Measures
Name Time Method Skeletal muscle blood flow Change from baseline to 4 weeks Femoral arterial blood flow measured at rest and during one leg knee extensor exercise
Blood clot structure-gel point Change from baseline to 4 weeks Blood clot structure is assessed by gel point
Blood clot structure-fractal analysis Change from baseline to 4 weeks Blood clot structure is assessed by fractal analysis
Platelet reactivity Change from baseline to 4 weeks Platelet reactivity is assessed in platelets isolated from blood samples
Skeletal muscle proteins Change from baseline to 4 weeks Proteins associated with angiogenesis and vascular function are assessed in skeletal muscle samples obtained from the thigh muscle
Plasma proteins Change from baseline to 4 weeks Protein amount is determined in plasma
Cerebral vascular function-visual task Change from baseline to 4 weeks Assessment of change in cerebral blood flow velocity with visual task
Cerebral vascular function- motorparadigm task Change from baseline to 4 weeks Assessment of change in cerebral blood flow velocity with motorparadigm task
Oral glucose tolerance test (OGTT) Change from baseline to 4 weeks An oral glucose tolerance test is conducted by assesment of blood glucose and insulin before and after ingestion of glucose
Body composition Change from baseline to 4 weeks Body composition is assessed by dual energy x-ray absorptiometry
Plasma lipids Change from baseline to 4 weeks Lipid concentration is determined in plasma
Trial Locations
- Locations (2)
University of Copenhagen
🇩🇰Copenhagen, Denmark
Department of Neurology, Herlev Hospital
🇩🇰Herlev, Denmark
University of Copenhagen🇩🇰Copenhagen, Denmark