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Completed

NCT Number: NCT03635177

Effect of Remote Ischemic Conditioning on Vascular Health in Stroke Patients

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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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Copenhagen, Copenhagen, Denmark

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About this study

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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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Remote Ischemic conditioning

Procedure

Four weeks of daily ischemic conditioning and four weeks of sham ischemic conditioning in a cross over design

Other names: Sham remote ischemic conditioning

Primary outcomes

  1. 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 outcomes

  1. Cerebral vascular function-visual task

    Time frame: Change from baseline to 4 weeks

    Assessment of change in cerebral blood flow velocity with visual task

  2. Cerebral vascular function- motorparadigm task

    Time frame: Change from baseline to 4 weeks

    Assessment of change in cerebral blood flow velocity with motorparadigm task

  3. 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

  4. Platelet reactivity

    Time frame: Change from baseline to 4 weeks

    Platelet reactivity is assessed in platelets isolated from blood samples

  5. Blood clot structure-gel point

    Time frame: Change from baseline to 4 weeks

    Blood clot structure is assessed by gel point

  6. Blood clot structure-fractal analysis

    Time frame: Change from baseline to 4 weeks

    Blood clot structure is assessed by fractal analysis

  7. 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

  8. Plasma proteins

    Time frame: Change from baseline to 4 weeks

    Protein amount is determined in plasma

  9. Plasma lipids

    Time frame: Change from baseline to 4 weeks

    Lipid concentration is determined in plasma

  10. 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

  11. Body composition

    Time frame: Change from baseline to 4 weeks

    Body composition is assessed by dual energy x-ray absorptiometry

Sponsors and collaborators

Lead sponsor

University of Copenhagen

Other

Collaborators

  • Herlev Hospital

Registry information

Acronym: VISP

Important dates

Study start
2019
Primary completion
2022
Study completion
2022
First posted
Aug 17, 2018
Registry last updated
Nov 2, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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