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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03635177
Recruitment Status : Completed
First Posted : August 17, 2018
Last Update Posted : November 2, 2022
Sponsor:
Collaborator:
Herlev Hospital
Information provided by (Responsible Party):
Ylva Hellsten, University of Copenhagen

Tracking Information
First Submitted Date  ICMJE July 26, 2018
First Posted Date  ICMJE August 17, 2018
Last Update Posted Date November 2, 2022
Actual Study Start Date  ICMJE March 10, 2019
Actual Primary Completion Date October 20, 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 14, 2018)
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
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: August 17, 2018)
  • Cerebral vascular function-visual task [ Time Frame: Change from baseline to 4 weeks ]
    Assessment of change in cerebral blood flow velocity with visual task
  • Cerebral vascular function- motorparadigm task [ Time Frame: Change from baseline to 4 weeks ]
    Assessment of change in cerebral blood flow velocity with motorparadigm task
  • 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
  • Platelet reactivity [ Time Frame: Change from baseline to 4 weeks ]
    Platelet reactivity is assessed in platelets isolated from blood samples
  • Blood clot structure-gel point [ Time Frame: Change from baseline to 4 weeks ]
    Blood clot structure is assessed by gel point
  • Blood clot structure-fractal analysis [ Time Frame: Change from baseline to 4 weeks ]
    Blood clot structure is assessed by fractal analysis
  • 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
  • Plasma proteins [ Time Frame: Change from baseline to 4 weeks ]
    Protein amount is determined in plasma
  • Plasma lipids [ Time Frame: Change from baseline to 4 weeks ]
    Lipid concentration is determined in plasma
  • 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
  • Body composition [ Time Frame: Change from baseline to 4 weeks ]
    Body composition is assessed by dual energy x-ray absorptiometry
Original Secondary Outcome Measures  ICMJE
 (submitted: August 14, 2018)
  • Cerebral vascular function-visual task [ Time Frame: Change from baseline to 4 weeks ]
    Assessment of change in cerebral blood flow velocity with visual task
  • Cerebral vascular function- motorparadigm task [ Time Frame: Change from baseline to 4 weeks ]
    Assessment of change in cerebral blood flow velocity with motorparadigm task
  • 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
  • Platelet function and activation [ Time Frame: Change from baseline to 4 weeks ]
    Platelet activation is assessed in platelets isolated from blood samples
  • Blood clot structure-gel point [ Time Frame: Change from baseline to 4 weeks ]
    Blood clot structure is assessed by gel point
  • Blood clot structure-fractal analysis [ Time Frame: Change from baseline to 4 weeks ]
    Blood clot structure is assessed by fractal analysis
  • 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
  • Plasma proteins [ Time Frame: Change from baseline to 4 weeks ]
    Protein amount is determined in plasma
  • Plasma lipids [ Time Frame: Change from baseline to 4 weeks ]
    Lipid concentration is determined in plasma
  • 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
  • Body composition [ Time Frame: Change from baseline to 4 weeks ]
    Body composition is assessed by dual energy x-ray absorptiometry
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Effect of Remote Ischemic Conditioning on Vascular Health in Stroke Patients
Official Title  ICMJE Effect of Remote Ischemic Conditioning on Vascular Health in Stroke Patients
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.

.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Intervention 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)
Primary Purpose: Basic Science
Condition  ICMJE Stroke, Lacunar
Intervention  ICMJE Procedure: Remote ischemic conditioning
Four weeks of daily ischemic conditioning and four weeks of sham ischemic conditioning in a cross over design
Other Name: Sham remote ischemic conditioning
Study Arms  ICMJE
  • 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.
    Intervention: Procedure: 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.
    Intervention: Procedure: Remote ischemic conditioning
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: November 1, 2022)
30
Original Estimated Enrollment  ICMJE
 (submitted: August 14, 2018)
20
Actual Study Completion Date  ICMJE October 20, 2022
Actual Primary Completion Date October 20, 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Denmark
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03635177
Other Study ID Numbers  ICMJE RIC stroke
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Current Responsible Party Ylva Hellsten, University of Copenhagen
Original Responsible Party Same as current
Current Study Sponsor  ICMJE University of Copenhagen
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Herlev Hospital
Investigators  ICMJE Not Provided
PRS Account University of Copenhagen
Verification Date November 2022

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP