Effect of Remote Ischemic Conditioning on Vascular Health in Stroke Patients

Overview

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.

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Crossover Assignment
    • Primary Purpose: Basic Science
    • Masking: None (Open Label)
  • Study Primary Completion Date: February 20, 2021

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

  • Procedure: Remote ischemic conditioning
    • Four weeks of daily ischemic conditioning and four weeks of sham ischemic conditioning in a cross over design

Arms, Groups and Cohorts

  • Experimental: 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.
  • Sham Comparator: Sham occlusion
    • 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.

Clinical Trial Outcome Measures

Primary Measures

  • Flow mediated dilation
    • Time Frame: Change from baseline to 4 weeks
    • Assessment of brachial artery dilation after 5 min occlusion of upper arm by cuff

Secondary Measures

  • Cerebral vascular function-visual task
    • Time Frame: Change from baseline to 4 weeks
    • Assessment of change in cerebral blood flow velocity with visual task
  • Cerebral vascular function- motorparadigm task
    • Time Frame: Change from baseline to 4 weeks
    • Assessment of change in cerebral blood flow velocity with motorparadigm task
  • Skeletal muscle blood flow
    • Time Frame: Change from baseline to 4 weeks
    • Femoral arterial blood flow measured at rest and during one leg knee extensor exercise
  • Platelet reactivity
    • Time Frame: Change from baseline to 4 weeks
    • Platelet reactivity is assessed in platelets isolated from blood samples
  • Blood clot structure-gel point
    • Time Frame: Change from baseline to 4 weeks
    • Blood clot structure is assessed by gel point
  • Blood clot structure-fractal analysis
    • Time Frame: Change from baseline to 4 weeks
    • Blood clot structure is assessed by fractal analysis
  • Skeletal muscle proteins
    • 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
  • Plasma proteins
    • Time Frame: Change from baseline to 4 weeks
    • Protein amount is determined in plasma
  • Plasma lipids
    • Time Frame: Change from baseline to 4 weeks
    • Lipid concentration is determined in plasma
  • Oral glucose tolerance test (OGTT)
    • 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
  • Body composition
    • Time Frame: Change from baseline to 4 weeks
    • Body composition is assessed by dual energy x-ray absorptiometry

Participating in This Clinical Trial

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.
  • Gender Eligibility: All

    Minimum Age: 18 Years

    Maximum Age: N/A

    Are Healthy Volunteers Accepted: No

    Investigator Details

    • Lead Sponsor
      • University of Copenhagen
    • Collaborator
      • Herlev Hospital
    • Provider of Information About this Clinical Study
      • Principal Investigator: Ylva Hellsten, Professor – University of Copenhagen
    • Overall Contact(s)
      • Lene Stevner, +45 35332371, less@nexs.ku.dk

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