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History of Changes for Study: NCT03635177
Effect of Remote Ischemic Conditioning on Vascular Health in Stroke Patients (VISP)
Latest version (submitted November 1, 2022) on ClinicalTrials.gov
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Study Record Versions
Version A B Submitted Date Changes
1 August 14, 2018 None (earliest Version on record)
2 August 17, 2018 Outcome Measures and Study Status
3 October 29, 2018 Study Status
4 April 2, 2019 Recruitment Status, Study Status and Contacts/Locations
5 August 7, 2019 Study Status, Study Design and Study Description
6 October 18, 2021 Recruitment Status, Study Status and Contacts/Locations
7 November 1, 2022 Recruitment Status, Study Status and Study Design
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Study NCT03635177
Submitted Date:  August 14, 2018 (v1)

Open or close this module Study Identification
Unique Protocol ID: RIC stroke
Brief Title: Effect of Remote Ischemic Conditioning on Vascular Health in Stroke Patients (VISP)
Official Title: Effect of Remote Ischemic Conditioning on Vascular Health in Stroke Patients
Secondary IDs:
Open or close this module Study Status
Record Verification: August 2018
Overall Status: Not yet recruiting
Study Start: August 20, 2018
Primary Completion: August 20, 2019 [Anticipated]
Study Completion: August 20, 2020 [Anticipated]
First Submitted: July 26, 2018
First Submitted that
Met QC Criteria:
August 14, 2018
First Posted: August 17, 2018 [Actual]
Last Update Submitted that
Met QC Criteria:
August 14, 2018
Last Update Posted: August 17, 2018 [Actual]
Open or close this module Sponsor/Collaborators
Sponsor: University of Copenhagen
Responsible Party: Principal Investigator
Investigator: Ylva Hellsten
Official Title: Professor
Affiliation: University of Copenhagen
Collaborators: Herlev Hospital
Open or close this module Oversight
U.S. FDA-regulated Drug: No
U.S. FDA-regulated Device: No
Data Monitoring: No
Open or close this module 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 four 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 four weeks of homebased RIC treatment and four weeks of sham treatment 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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Open or close this module Conditions
Conditions: Stroke, Lacunar
Keywords:
Open or close this module Study Design
Study Type: Interventional
Primary Purpose: Basic Science
Study Phase: Not Applicable
Interventional Study Model: Crossover Assignment
The patients will undergo four weeks of the intervention and four weeks of sham, separated by two weeks. The intervention consists of inflating a cuff on the upperarm to 200 mmHg for 4 x 5 minutes, performed every day. Sham consists of the same procedure but the cuff is inflated to 30 mm Hg.
Number of Arms: 2
Masking: None (Open Label)
Allocation: Randomized
Enrollment: 20 [Anticipated]
Open or close this module Arms and Interventions
Arms Assigned Interventions
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
Open or close this module Outcome Measures
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 function and activation
[ Time Frame: Change from baseline to 4 weeks ]

Platelet activation 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
Open or close this module Eligibility
Minimum Age: 18 Years
Maximum Age:
Sex: All
Gender Based:
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.
Open or close this module Contacts/Locations
Central Contact Person: Lene Stevner
Telephone: +45 35332371
Email: less@nexs.ku.dk
Locations: Denmark
University of Copenhagen
Copenhagen, Denmark
Contact:Contact: Lasse Gliemann, PhD gliemann@nexs.ku.dk
Contact:Contact: Nicolai R Mortensen, MSc 22131945 nim@nexs.ku.dk
Contact:Principal Investigator: Ylva Hellsten, PhD
Contact:Sub-Investigator: Christina Kruuse, MD PhD
Open or close this module IPDSharing
Plan to Share IPD:
Open or close this module References
Citations:
Links:
Available IPD/Information:

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