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

Primary Purpose

Stroke, Lacunar

Status
Completed
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
Remote ischemic conditioning
Sponsored by
University of Copenhagen
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Stroke, Lacunar

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • University of Copenhagen
  • Department of Neurology, Herlev Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Sham Comparator

Arm Label

Remote ischemic conditioning

Sham occlusion

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Flow mediated dilation
Assessment of brachial artery dilation after 5 min occlusion of upper arm by cuff

Secondary Outcome Measures

Cerebral vascular function-visual task
Assessment of change in cerebral blood flow velocity with visual task
Cerebral vascular function- motorparadigm task
Assessment of change in cerebral blood flow velocity with motorparadigm task
Skeletal muscle blood flow
Femoral arterial blood flow measured at rest and during one leg knee extensor exercise
Platelet reactivity
Platelet reactivity is assessed in platelets isolated from blood samples
Blood clot structure-gel point
Blood clot structure is assessed by gel point
Blood clot structure-fractal analysis
Blood clot structure is assessed by fractal analysis
Skeletal muscle proteins
Proteins associated with angiogenesis and vascular function are assessed in skeletal muscle samples obtained from the thigh muscle
Plasma proteins
Protein amount is determined in plasma
Plasma lipids
Lipid concentration is determined in plasma
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
Body composition
Body composition is assessed by dual energy x-ray absorptiometry

Full Information

First Posted
July 26, 2018
Last Updated
November 1, 2022
Sponsor
University of Copenhagen
Collaborators
Herlev Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT03635177
Brief Title
Effect of Remote Ischemic Conditioning on Vascular Health in Stroke Patients
Acronym
VISP
Official Title
Effect of Remote Ischemic Conditioning on Vascular Health in Stroke Patients
Study Type
Interventional

2. Study Status

Record Verification Date
November 2022
Overall Recruitment Status
Completed
Study Start Date
March 10, 2019 (Actual)
Primary Completion Date
October 20, 2022 (Actual)
Study Completion Date
October 20, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Copenhagen
Collaborators
Herlev Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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. .

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke, Lacunar

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
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)
Allocation
Randomized
Enrollment
30 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Remote ischemic conditioning
Arm Type
Experimental
Arm Description
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.
Arm Title
Sham occlusion
Arm Type
Sham Comparator
Arm Description
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.
Intervention Type
Procedure
Intervention Name(s)
Remote ischemic conditioning
Other Intervention Name(s)
Sham remote ischemic conditioning
Intervention Description
Four weeks of daily ischemic conditioning and four weeks of sham ischemic conditioning in a cross over design
Primary Outcome Measure Information:
Title
Flow mediated dilation
Description
Assessment of brachial artery dilation after 5 min occlusion of upper arm by cuff
Time Frame
Change from baseline to 4 weeks
Secondary Outcome Measure Information:
Title
Cerebral vascular function-visual task
Description
Assessment of change in cerebral blood flow velocity with visual task
Time Frame
Change from baseline to 4 weeks
Title
Cerebral vascular function- motorparadigm task
Description
Assessment of change in cerebral blood flow velocity with motorparadigm task
Time Frame
Change from baseline to 4 weeks
Title
Skeletal muscle blood flow
Description
Femoral arterial blood flow measured at rest and during one leg knee extensor exercise
Time Frame
Change from baseline to 4 weeks
Title
Platelet reactivity
Description
Platelet reactivity is assessed in platelets isolated from blood samples
Time Frame
Change from baseline to 4 weeks
Title
Blood clot structure-gel point
Description
Blood clot structure is assessed by gel point
Time Frame
Change from baseline to 4 weeks
Title
Blood clot structure-fractal analysis
Description
Blood clot structure is assessed by fractal analysis
Time Frame
Change from baseline to 4 weeks
Title
Skeletal muscle proteins
Description
Proteins associated with angiogenesis and vascular function are assessed in skeletal muscle samples obtained from the thigh muscle
Time Frame
Change from baseline to 4 weeks
Title
Plasma proteins
Description
Protein amount is determined in plasma
Time Frame
Change from baseline to 4 weeks
Title
Plasma lipids
Description
Lipid concentration is determined in plasma
Time Frame
Change from baseline to 4 weeks
Title
Oral glucose tolerance test (OGTT)
Description
An oral glucose tolerance test is conducted by assesment of blood glucose and insulin before and after ingestion of glucose
Time Frame
Change from baseline to 4 weeks
Title
Body composition
Description
Body composition is assessed by dual energy x-ray absorptiometry
Time Frame
Change from baseline to 4 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Facility Information:
Facility Name
University of Copenhagen
City
Copenhagen
ZIP/Postal Code
2100
Country
Denmark
Facility Name
Department of Neurology, Herlev Hospital
City
Herlev
ZIP/Postal Code
2730
Country
Denmark

12. IPD Sharing Statement

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Effect of Remote Ischemic Conditioning on Vascular Health in Stroke Patients

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