Effect of Remote Ischemic Conditioning on Vascular Health in Stroke Patients

Stroke, Lacunar Clinical Trial

— VISP  

Official title:

Effect of Remote Ischemic Conditioning on Vascular Health in Stroke Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03635177
• Other study ID #: RIC stroke
• Status: Completed
• Phase: N/A
• Start date: March 10, 2019
• Est. completion date: October 20, 2022

Study information

• Verified date: November 2022
• Source: University of Copenhagen
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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. .

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: October 20, 2022
• Est. primary completion date: October 20, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Stroke
• Stroke, Lacunar

Intervention

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

Locations

Country	Name	City	State
Denmark	University of Copenhagen	Copenhagen
Denmark	Department of Neurology, Herlev Hospital	Herlev

Sponsors (2)

Lead Sponsor	Collaborator
University of Copenhagen	Herlev Hospital

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Flow mediated dilation	Assessment of brachial artery dilation after 5 min occlusion of upper arm by cuff	Change from baseline to 4 weeks
Secondary	Cerebral vascular function-visual task	Assessment of change in cerebral blood flow velocity with visual task	Change from baseline to 4 weeks
Secondary	Cerebral vascular function- motorparadigm task	Assessment of change in cerebral blood flow velocity with motorparadigm task	Change from baseline to 4 weeks
Secondary	Skeletal muscle blood flow	Femoral arterial blood flow measured at rest and during one leg knee extensor exercise	Change from baseline to 4 weeks
Secondary	Platelet reactivity	Platelet reactivity is assessed in platelets isolated from blood samples	Change from baseline to 4 weeks
Secondary	Blood clot structure-gel point	Blood clot structure is assessed by gel point	Change from baseline to 4 weeks
Secondary	Blood clot structure-fractal analysis	Blood clot structure is assessed by fractal analysis	Change from baseline to 4 weeks
Secondary	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
Secondary	Plasma proteins	Protein amount is determined in plasma	Change from baseline to 4 weeks
Secondary	Plasma lipids	Lipid concentration is determined in plasma	Change from baseline to 4 weeks
Secondary	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
Secondary	Body composition	Body composition is assessed by dual energy x-ray absorptiometry	Change from baseline to 4 weeks