Clinical trial NCT03635177: Effect of Remote Ischemic Conditioning on Vascular Health in Stroke Patients
Official title: Effect of Remote Ischemic Conditioning on Vascular Health in Stroke Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stroke, Lacunar
Lead sponsor: University of Copenhagen
Sponsor class: OTHER
Collaborators: name: Herlev Hospital
First posted: 2018-08-17
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
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.
Primary purpose: BASIC_SCIENCE

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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Eligibility criteria: 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.

Primary outcomes:
measure: Flow mediated dilation
timeFrame: Change from baseline to 4 weeks
Secondary outcomes:
measure: Cerebral vascular function-visual task
timeFrame: Change from baseline to 4 weeks
measure: Cerebral vascular function- motorparadigm task
timeFrame: Change from baseline to 4 weeks
measure: Skeletal muscle blood flow
timeFrame: Change from baseline to 4 weeks
measure: Platelet reactivity
timeFrame: Change from baseline to 4 weeks
measure: Blood clot structure-gel point
timeFrame: Change from baseline to 4 weeks
measure: Blood clot structure-fractal analysis
timeFrame: Change from baseline to 4 weeks
measure: Skeletal muscle proteins
timeFrame: Change from baseline to 4 weeks
measure: Plasma proteins
timeFrame: Change from baseline to 4 weeks
measure: Plasma lipids
timeFrame: Change from baseline to 4 weeks
measure: Oral glucose tolerance test (OGTT)
timeFrame: Change from baseline to 4 weeks
measure: Body composition
timeFrame: Change from baseline to 4 weeks
Other outcomes:
Locations:
city: Copenhagen
country: Denmark
facility: University of Copenhagen
city: Herlev
country: Denmark
facility: Department of Neurology, Herlev Hospital
Study officials:
References: