Effect of Remote Ischemic Conditioning on Vascular Health in Stroke Patients

NCT03635177 | Completed

• 1 other identifier: RIC stroke
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 2

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.

Conditions

Stroke, Lacunar

Outcome Measures

Primary Outcomes (1)

• Flow mediated dilation

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

  Change from baseline to 4 weeks

Secondary Outcomes (11)

• Cerebral vascular function-visual task

  Change from baseline to 4 weeks

• Cerebral vascular function- motorparadigm task

  Change from baseline to 4 weeks

• Skeletal muscle blood flow

  Change from baseline to 4 weeks

• Platelet reactivity

  Change from baseline to 4 weeks

• Blood clot structure-gel point

  Change from baseline to 4 weeks

Study Arms (2)

Remote ischemic conditioning

EXPERIMENTAL

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

Sham occlusion

SHAM COMPARATOR

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

Interventions

Remote ischemic conditioning PROCEDURE

Four weeks of daily ischemic conditioning and four weeks of sham ischemic conditioning in a cross over design

Also known as: Sham remote ischemic conditioning

Remote ischemic conditioning; Sham occlusion

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Copenhagen: lead
• Herlev Hospital: collaborator

Study Sites (2)

University of Copenhagen

Copenhagen, 2100, Denmark

Location

Department of Neurology, Herlev Hospital

Herlev, 2730, Denmark

Location

Related Publications (1)

• Norregaard LB, Wickham KA, Jeppesen JS, Rytter N, Christoffersen LC, Gliemann L, Lawrence M, Evans PA, Kruuse C, Hellsten Y. Exercise transiently increases the density of incipient blood clots in antiplatelet-treated lacunar stroke patients. Thromb J. 2024 Apr 5;22(1):35. doi: 10.1186/s12959-024-00604-9.

  PMID: 38581046 DERIVED

MeSH Terms

Conditions

Stroke, Lacunar

Condition Hierarchy (Ancestors)

Cerebral Small Vessel Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Thrombotic Stroke; Ischemic Stroke; Stroke; Vascular Diseases; Cardiovascular Diseases; Brain Infarction; Infarction; Ischemia; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Necrosis

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: 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.

Study Record Dates

• First Submitted: July 26, 2018
• First Posted: August 17, 2018
• Study Start: March 10, 2019
• Primary Completion: October 20, 2022
• Study Completion: October 20, 2022
• Last Updated: November 2, 2022

Record last verified: 2022-11

Locations

DK (2)