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Effect of Remote Ischemic Conditioning on Vascular Health in Stroke Patients (VISP)

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ClinicalTrials.gov Identifier: NCT03635177
Recruitment Status : Completed
First Posted : August 17, 2018
Last Update Posted : November 2, 2022
Sponsor:
Collaborator:
Herlev Hospital
Information provided by (Responsible Party):
Ylva Hellsten, 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.

Condition or disease Intervention/treatment Phase
Stroke, Lacunar Procedure: Remote ischemic conditioning Not Applicable

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 Type : Interventional  (Clinical Trial)
Actual Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
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.
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: Effect of Remote Ischemic Conditioning on Vascular Health in Stroke Patients
Actual Study Start Date : March 10, 2019
Actual Primary Completion Date : October 20, 2022
Actual Study Completion Date : October 20, 2022

Arm Intervention/treatment
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.
Procedure: Remote ischemic conditioning
Four weeks of daily ischemic conditioning and four weeks of sham ischemic conditioning in a cross over design
Other Name: Sham remote ischemic conditioning

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.
Procedure: Remote ischemic conditioning
Four weeks of daily ischemic conditioning and four weeks of sham ischemic conditioning in a cross over design
Other Name: Sham remote ischemic conditioning




Primary Outcome Measures :
  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 Outcome Measures :
  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



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03635177


Locations
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Denmark
University of Copenhagen
Copenhagen, Denmark, 2100
Department of Neurology, Herlev Hospital
Herlev, Denmark, 2730
Sponsors and Collaborators
University of Copenhagen
Herlev Hospital
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Responsible Party: Ylva Hellsten, Professor, University of Copenhagen
ClinicalTrials.gov Identifier: NCT03635177    
Other Study ID Numbers: RIC stroke
First Posted: August 17, 2018    Key Record Dates
Last Update Posted: November 2, 2022
Last Verified: November 2022

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Stroke
Stroke, Lacunar
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Cerebral Small Vessel Diseases
Thrombotic Stroke
Ischemic Stroke
Brain Infarction
Infarction
Ischemia
Pathologic Processes
Necrosis