Stroke, LacunarVISPNCT03635177
Effect of Remote Ischemic Conditioning on Vascular Health in Stroke Patients
A study testing Remote ischemic conditioning in people with Stroke, Lacunar, run by University of Copenhagen at 2 sites in Denmark.
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stroke, Lacunar
- What is being tested?
- Remote ischemic conditioning
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 2 sitesDenmark
- Study dates
- 10 Mar 2019to 20 Oct 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
2 sites in 1 country.
Denmark2 sites
University of Copenhagen
Copenhagen, 2100
Department of Neurology, Herlev Hospital
Herlev, 2730
About this study
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.
Read the 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.
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- Conditions
- Stroke, Lacunar
- Being tested
- Remote ischemic conditioning
- Medical subject headings
- Stroke, Lacunar
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Remote ischemic conditioningProcedure or surgery
Also called Sham remote ischemic conditioning
Four weeks of daily ischemic conditioning and four weeks of sham ischemic conditioning in a cross over design
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Procedure: Remote ischemic conditioning |
What is being measured
The primary outcome is the main question the study is designed to answer.
Flow mediated dilation
Assessment of brachial artery dilation after 5 min occlusion of upper arm by cuff
Measured: Change from baseline to 4 weeks
Secondary outcomes (11)
Cerebral vascular function-visual task
Assessment of change in cerebral blood flow velocity with visual task
Measured: Change from baseline to 4 weeks
Cerebral vascular function- motorparadigm task
Assessment of change in cerebral blood flow velocity with motorparadigm task
Measured: Change from baseline to 4 weeks
Skeletal muscle blood flow
Femoral arterial blood flow measured at rest and during one leg knee extensor exercise
Measured: Change from baseline to 4 weeks
Platelet reactivity
Platelet reactivity is assessed in platelets isolated from blood samples
Measured: Change from baseline to 4 weeks
Blood clot structure-gel point
Blood clot structure is assessed by gel point
Measured: Change from baseline to 4 weeks
Blood clot structure-fractal analysis
Blood clot structure is assessed by fractal analysis
Measured: Change from baseline to 4 weeks
Skeletal muscle proteins
Proteins associated with angiogenesis and vascular function are assessed in skeletal muscle samples obtained from the thigh muscle
Measured: Change from baseline to 4 weeks
Plasma proteins
Protein amount is determined in plasma
Measured: Change from baseline to 4 weeks
Plasma lipids
Lipid concentration is determined in plasma
Measured: Change from baseline to 4 weeks
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
Measured: Change from baseline to 4 weeks
Body composition
Body composition is assessed by dual energy x-ray absorptiometry
Measured: Change from baseline to 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Aug 2018
- Study start10 Mar 2019
- Primary completion20 Oct 2022
- Study completion20 Oct 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Stroke, LacunarStudies of the same condition, open and under way.
- More trials run by University of CopenhagenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- 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)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Copenhagen
- Sponsor type
- University, hospital or other
- Collaborators
- Herlev Hospital
- Responsible party
- Principal investigator, Ylva Hellsten, University of Copenhagen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03635177
- Sponsor's protocol ID
- RIC stroke
- Acronym
- VISP
- Status last verified
- Nov 2022
- First submitted
- 26 Jul 2018
- Last updated
- 2 Nov 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 38581046
Study at a glance
From the registry record, last updated by the sponsor on 2 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Remote Ischemic Conditioning on Vascular Health in Stroke Patients
- ClinicalTrials.gov ID
- NCT03635177
- Acronym / sponsor ID
- VISP / RIC stroke
- Conditions
- Stroke, Lacunar
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- University of CopenhagenUniversity, hospital or other
- Collaborators
- Herlev Hospital
- Study start
- 10 Mar 2019 (actual)
- Primary completion
- 20 Oct 2022 (actual)
- Study completion
- 20 Oct 2022 (actual)
- First posted
- 17 Aug 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Remote ischemic conditioning | Experimental | Procedure: Remote ischemic conditioningThe 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. |
| Sham occlusion | Sham comparator | Procedure: Remote ischemic conditioningThe 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Remote ischemic conditioningAlso: Sham remote ischemic conditioningFour weeks of daily ischemic conditioning and four weeks of sham ischemic conditioning in a cross over design | Procedure or surgery | Remote ischemic conditioning, Sham occlusion |
Primary outcome
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
11 secondary outcomes
Cerebral vascular function-visual task
Time frame: Change from baseline to 4 weeks
Cerebral vascular function- motorparadigm task
Time frame: Change from baseline to 4 weeks
Skeletal muscle blood flow
Time frame: Change from baseline to 4 weeks
Platelet reactivity
Time frame: Change from baseline to 4 weeks
Blood clot structure-gel point
Time frame: Change from baseline to 4 weeks
Blood clot structure-fractal analysis
Time frame: Change from baseline to 4 weeks
Skeletal muscle proteins
Time frame: Change from baseline to 4 weeks
Plasma proteins
Time frame: Change from baseline to 4 weeks
Plasma lipids
Time frame: Change from baseline to 4 weeks
Oral glucose tolerance test (OGTT)
Time frame: Change from baseline to 4 weeks
Body composition
Time frame: Change from baseline to 4 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Nov 2022.
- Derived from this study: PubMed 38581046Norregaard 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Remote ischemic conditioning in people with Stroke, Lacunar, run by University of Copenhagen at 2 sites in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Flow mediated dilation (time frame: Change from baseline to 4 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03635177, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Nov 2022.