Stroke, Lacunar
Conditions
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. .
Interventions
PROCEDURERemote ischemic conditioning
Four weeks of daily ischemic conditioning and four weeks of sham ischemic conditioning in a cross over design
Sponsors
Herlev Hospital
University of Copenhagen
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
BASIC_SCIENCE
Masking
NONE
Intervention model description
The patients will undergo two weeks of the intervention and two weeks of controlperiod, separated by three weeks. The intervention consists of inflating a cuff on the upperarm to 200 mmHg for 4 x 5 minutes, performed every day. The control period includes no specific intervention.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Flow mediated dilation | Change from baseline to 4 weeks | Assessment of brachial artery dilation after 5 min occlusion of upper arm by cuff |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Cerebral vascular function- motorparadigm task | Change from baseline to 4 weeks | Assessment of change in cerebral blood flow velocity with motorparadigm task |
| Skeletal muscle blood flow | Change from baseline to 4 weeks | Femoral arterial blood flow measured at rest and during one leg knee extensor exercise |
| Platelet reactivity | Change from baseline to 4 weeks | Platelet reactivity is assessed in platelets isolated from blood samples |
| 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 |
| Cerebral vascular function-visual task | Change from baseline to 4 weeks | Assessment of change in cerebral blood flow velocity with visual task |
| Plasma proteins | Change from baseline to 4 weeks | Protein amount is determined in plasma |
| Plasma lipids | Change from baseline to 4 weeks | Lipid concentration is determined in plasma |
| 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 |
| 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 |
Countries
Denmark
Outcome results
None listed