Remote Ischemic conditioning
ProcedureFour weeks of daily ischemic conditioning and four weeks of sham ischemic conditioning in a cross over design
Other names: Sham remote ischemic conditioning
NCT Number: NCT03635177
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.
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Notify Me18 year and older
All sexes
Interventional
Not applicable
University of Copenhagen, Copenhagen, Denmark
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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Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Clinical significant carotid stenosis. Cardioembolic stroke
Four weeks of daily ischemic conditioning and four weeks of sham ischemic conditioning in a cross over design
Other names: Sham remote ischemic conditioning
Time frame: Change from baseline to 4 weeks
Assessment of brachial artery dilation after 5 min occlusion of upper arm by cuff
Time frame: Change from baseline to 4 weeks
Assessment of change in cerebral blood flow velocity with visual task
Time frame: Change from baseline to 4 weeks
Assessment of change in cerebral blood flow velocity with motorparadigm task
Time frame: Change from baseline to 4 weeks
Femoral arterial blood flow measured at rest and during one leg knee extensor exercise
Time frame: Change from baseline to 4 weeks
Platelet reactivity is assessed in platelets isolated from blood samples
Time frame: Change from baseline to 4 weeks
Blood clot structure is assessed by gel point
Time frame: Change from baseline to 4 weeks
Blood clot structure is assessed by fractal analysis
Time frame: Change from baseline to 4 weeks
Proteins associated with angiogenesis and vascular function are assessed in skeletal muscle samples obtained from the thigh muscle
Time frame: Change from baseline to 4 weeks
Protein amount is determined in plasma
Time frame: Change from baseline to 4 weeks
Lipid concentration is determined in plasma
Time frame: 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
Time frame: Change from baseline to 4 weeks
Body composition is assessed by dual energy x-ray absorptiometry
University of Copenhagen
Other
Acronym: VISP
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