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

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 Overview

• Status: Completed
• Conditions: Stroke, Lacunar
• Intervention / Treatment: Procedure: Remote ischemic conditioning

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
• Enrollment (Actual): 30
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Denmark
  • Copenhagen, Denmark, 2100
    • University of Copenhagen
  • Herlev, Denmark, 2730
    • Department of Neurology, Herlev Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / 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 Names: 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 Names: Sham remote ischemic conditioning

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cerebral vascular function-visual task	Assessment of change in cerebral blood flow velocity with visual task	Change from baseline to 4 weeks
Cerebral vascular function- motorparadigm task	Assessment of change in cerebral blood flow velocity with motorparadigm task	Change from baseline to 4 weeks
Skeletal muscle blood flow	Femoral arterial blood flow measured at rest and during one leg knee extensor exercise	Change from baseline to 4 weeks
Platelet reactivity	Platelet reactivity is assessed in platelets isolated from blood samples	Change from baseline to 4 weeks
Blood clot structure-gel point	Blood clot structure is assessed by gel point	Change from baseline to 4 weeks
Blood clot structure-fractal analysis	Blood clot structure is assessed by fractal analysis	Change from baseline to 4 weeks
Skeletal muscle proteins	Proteins associated with angiogenesis and vascular function are assessed in skeletal muscle samples obtained from the thigh muscle	Change from baseline to 4 weeks
Plasma proteins	Protein amount is determined in plasma	Change from baseline to 4 weeks
Plasma lipids	Lipid concentration is determined in plasma	Change from baseline to 4 weeks
Oral glucose tolerance test (OGTT)	An oral glucose tolerance test is conducted by assesment of blood glucose and insulin before and after ingestion of glucose	Change from baseline to 4 weeks
Body composition	Body composition is assessed by dual energy x-ray absorptiometry	Change from baseline to 4 weeks

Collaborators and Investigators

• Sponsor: University of Copenhagen
• Collaborators: Herlev Hospital

Study record dates

Study Major Dates

• Study Start (Actual): March 10, 2019
• Primary Completion (Actual): October 20, 2022
• Study Completion (Actual): October 20, 2022

Study Registration Dates

• First Submitted: July 26, 2018
• First Submitted That Met QC Criteria: August 14, 2018
• First Posted (Actual): August 17, 2018

Study Record Updates

• Last Update Posted (Actual): November 2, 2022
• Last Update Submitted That Met QC Criteria: November 1, 2022
• Last Verified: November 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Ischemia; Pathologic Processes; Necrosis; Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Infarction; Brain Infarction; Cerebral Small Vessel Diseases; Thrombotic Stroke; Ischemic Stroke; Stroke; Stroke, Lacunar
• Other Study ID Numbers: RIC stroke

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No