Effect of Remote Ischemic Conditioning on Vascular Health in Stroke Patients

Not Applicable

Completed

• Conditions: Stroke, Lacunar
• Interventions: Procedure: Remote ischemic conditioning

• 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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Study Timeline

• Study First Submitted: 2018-07-26
• Study First Submitted QC: 2018-08-14
• Study First Posted: 2018-08-17
• Study Start: 2019-03-10
• Primary Completion: 2022-10-20
• Study Completion: 2022-10-20
• Status Verified: 2022-11
• Last Update Submitted: 2022-11-01
• Last Update Posted: 2022-11-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Sham occlusion	Remote ischemic conditioning	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.
Remote ischemic conditioning	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.

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
Plasma lipids	Change from baseline to 4 weeks	Lipid concentration is determined in plasma
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- motorparadigm task	Change from baseline to 4 weeks	Assessment of change in cerebral blood flow velocity with motorparadigm task
Cerebral vascular function-visual task	Change from baseline to 4 weeks	Assessment of change in cerebral blood flow velocity with visual 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

Trial Locations

Locations (2)

Department of Neurology, Herlev Hospital; 🇩🇰 Herlev, Denmark

University of Copenhagen; 🇩🇰 Copenhagen, Denmark