Effect of Remote Ischemic Conditioning on Vascular Health in Stroke Patients

NCT ID: NCT03635177

Last Updated: 2022-11-02

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-03-10
• Study Completion Date: 2022-10-20

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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Conditions

Stroke, Lacunar

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Remote ischemic conditioning

Intervention Type: PROCEDURE

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

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.

Group Type: SHAM_COMPARATOR

Remote ischemic conditioning

Intervention Type: PROCEDURE

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

Interventions

Remote ischemic conditioning

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

Intervention Type: PROCEDURE

Other Intervention Names

Sham remote ischemic conditioning

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Herlev Hospital

OTHER

Sponsor Role: collaborator

University of Copenhagen

OTHER

Sponsor Role: lead

Responsible Party

Ylva Hellsten

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

University of Copenhagen

Copenhagen, , Denmark

Department of Neurology, Herlev Hospital

Herlev, , Denmark

Countries

Denmark

References

Norregaard LB, Wickham KA, Jeppesen JS, Rytter N, Christoffersen LC, Gliemann L, Lawrence M, Evans PA, Kruuse C, Hellsten Y. Exercise transiently increases the density of incipient blood clots in antiplatelet-treated lacunar stroke patients. Thromb J. 2024 Apr 5;22(1):35. doi: 10.1186/s12959-024-00604-9.

Reference Type: DERIVED

PMID: 38581046 (View on PubMed)

Other Identifiers

RIC stroke

Identifier Type: -

Identifier Source: org_study_id