Cerebral Small Vessel DiseasePhase 3RIPC-SVDNCT01658306
Clinical Trial on Remote Ischemic Preconditioning and Cerebral Small Vessel Disease
A Phase 3 study testing remote ischemic preconditioning in people with Cerebral Small Vessel Disease, run by Capital Medical University at 1 site in China.
Trial summary
The hypothesis of this study is that remote ischemic preconditioning (RIPC) might have a beneficial effect on outcomes of cerebral small vessel disease (CSV). Read more about this study
- Who is it for?
- Ages 40 to 80 years
- Conditions the study is for
- Cerebral Small Vessel Disease
- What is being tested?
- remote ischemic preconditioning
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 1 siteChina
- Study dates
- Jul 2012to Jun 2014
- Phase
- Phase 3
- 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 40 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subjects aged 40-80 years;
- Ischemic cerebrovascular event onset, if any, must be within 6 months;
- TCD and carotid ultrasound exclude vascular narrow that can cause hemodynamic changes (usually >50% narrow lumen);
- MRI confirmed the presence of lacunar infarction and / or generalized white matter lesions;
- Written consent was obtained from the subject.
Who cannot join
- History of intracranial hemorrhage;
- Significant bleeding from other parts of the body;
- History of atrial fibrillation;
- History of myocardial infarction within six months;
- Moyamoya disease or vasculitis;
- Hereditary small vessel disorders, such as CADASIL, FABRY, and mitochondrial encephalo-myopathy;
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- Significant bleeding-coagulation dysfunction;
- Abnormal blood pressure, glucose and/or lipids after restrict treatment regimen;
- Severe liver/kidney disease, cancer or critical illness of internal medicine and surgery.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Random Controlled, Double-Blind Clinical Trial: Remote Ischemic Preconditioning and Cerebral Small Vessel Disease
The hypothesis of this study is that remote ischemic preconditioning (RIPC) might have a beneficial effect on outcomes of cerebral small vessel disease (CSV).
Read the detailed description
CSV constitutes an important type of ischemic stroke due to a generalized hypo-perfusion of brain. Few treatment methods are available except some beneficial effect shown with nimodipine. The potential treatment effect of RIPC on protection of brain from cerebral small vessel disease has not been investigated. The investigators designed this randomized, double-blind, controlled clinical trial to examine (1) whether RIPC has a beneficial effect on brain lesions of CSV, and (2) whether RIPC can protect patients of CSV from cognitive deterioration. There are 2 arms in this trial: One arm is RIPC treatment, the other one is sham RIPC treatment. Brain lesions will be quantified by volumetric MRI, and Xe-CT will be used to evaluate cerebral blood perfusion. Cognitive function will be evaluated by mini-mental state examination (MMSE) and the Montreal Cognitive Assessment (MoCA).
- Conditions
- Cerebral Small Vessel Disease
- Being tested
- remote ischemic preconditioning, sham remote ischemic preconditioning
- Keywords
- remote ischemic preconditioning, random-controlled, double blind, RIPC
- Medical subject headings
- Cerebral Small Vessel Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
remote ischemic preconditioningProcedure or surgery
RIPC consists of five 5-min cycles of right upper arm ischemia/reperfusion, induced by an automated cuff-inflator placed on the right upper arm which is inflated to 200 mmHg for 5mins followed by deflating the cuff for 5mins, each patient in the RIPC group will have the treatment twice a day for two weeks.
sham remote ischemic preconditioningProcedure or surgery
Sham RIPC consists of five 5-min cycles of right upper arm ischemia/reperfusion, induced by an automated cuff-inflator placed on the right upper arm which is inflated to 50 mmHg for 5mins followed by deflating the cuff for 5mins, each patient in the placebo RIPC group will have the treatment twice a day for two weeks.
| Study group | Role | What they receive |
|---|---|---|
| remote ischemic preconditioning | Experimental | Receiving remote ischemic preconditioning (RIPC) treatment with pressure set at 200 mmHg. Receives: Procedure: remote ischemic preconditioning |
| placebo remote ischemic preconditioning | Sham comparator | Receiving sham RIPC treatment with pressure set at 50 mmHg Receives: Procedure: sham remote ischemic preconditioning |
What is being measured
The primary outcome is the main question the study is designed to answer.
changes in brain lesions
Volumetric MRI will be used for calculating changes in the number of lacunar infarctions and the total volume of white matter lesions
Measured: 0-24 months
Secondary outcomes (2)
Changes in the cognitive function
Cognitive function will be evaluated by mini-mental state examination (MMSE) and the Montreal Cognitive Assessment (MoCA).
Measured: 0-24 months
Changes in the cerebral blood perfusion
Cerebral blood perfusion will be evaluated by Xe-CT.
Measured: 0-24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Aug 2012 (estimated)
- Study startJul 2012
- Primary completionJun 2014
- Study completionJun 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Cerebral Small Vessel DiseaseStudies of the same condition, open and under way.
- More trials run by Capital Medical UniversityThe 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Capital Medical University
- Sponsor type
- University, hospital or other
- Collaborators
- Peking University First Hospital
- Responsible party
- Principal investigator, Ji Xunming, Capital Medical University
- Investigators
- Xunming Ji, M.D., Ph.D., Principal investigator, Xuan Wu Hospital of Capital Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01658306
- Sponsor's protocol ID
- D111107003111008
- Acronym
- RIPC-SVD
- Status last verified
- Nov 2014
- First submitted
- 26 Jul 2012
- Last updated
- 26 Nov 2014
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Wang Y, Meng R, Song H, Liu G, Hua Y, Cui D, Zheng L, Feng W, Liebeskind DS, Fisher M, Ji X. Remote Ischemic Conditioning May Improve Outcomes of Patients With Cerebral Small-Vessel Disease. Stroke. 2017 Nov;48(11):3064-3072. doi: 10.1161/STROKEAHA.117.017691. Epub 2017 Oct 17.
PubMed 29042490Mi T, Yu F, Ji X, Sun Y, Qu D. The Interventional Effect of Remote Ischemic Preconditioning on Cerebral Small Vessel Disease: A Pilot Randomized Clinical Trial. Eur Neurol. 2016;76(1-2):28-34. doi: 10.1159/000447536. Epub 2016 Jun 29.
PubMed 27351719
Study at a glance
From the registry record, last updated by the sponsor on 26 Nov 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Random Controlled, Double-Blind Clinical Trial: Remote Ischemic Preconditioning and Cerebral Small Vessel Disease
- ClinicalTrials.gov ID
- NCT01658306
- Acronym / sponsor ID
- RIPC-SVD / D111107003111008
- Conditions
- Cerebral Small Vessel Disease
- Keywords
- remote ischemic preconditioning, random-controlled, double blind, RIPC
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Capital Medical UniversityUniversity, hospital or other
- Collaborators
- Peking University First Hospital
- Study start
- Jul 2012
- Primary completion
- Jun 2014 (actual)
- Study completion
- Jun 2014 (actual)
- First posted
- 7 Aug 2012 (estimated)
- 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 hypothesis of this study is that remote ischemic preconditioning (RIPC) might have a beneficial effect on outcomes of cerebral small vessel disease (CSV).
Detailed description
CSV constitutes an important type of ischemic stroke due to a generalized hypo-perfusion of brain. Few treatment methods are available except some beneficial effect shown with nimodipine. The potential treatment effect of RIPC on protection of brain from cerebral small vessel disease has not been investigated. The investigators designed this randomized, double-blind, controlled clinical trial to examine (1) whether RIPC has a beneficial effect on brain lesions of CSV, and (2) whether RIPC can protect patients of CSV from cognitive deterioration. There are 2 arms in this trial: One arm is RIPC treatment, the other one is sham RIPC treatment. Brain lesions will be quantified by volumetric MRI, and Xe-CT will be used to evaluate cerebral blood perfusion. Cognitive function will be evaluated by mini-mental state examination (MMSE) and the Montreal Cognitive Assessment (MoCA).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| remote ischemic preconditioning | Experimental | Procedure: remote ischemic preconditioningReceiving remote ischemic preconditioning (RIPC) treatment with pressure set at 200 mmHg. |
| placebo remote ischemic preconditioning | Sham comparator | Procedure: sham remote ischemic preconditioningReceiving sham RIPC treatment with pressure set at 50 mmHg |
Who may qualify
- Ages
- 40 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Subjects aged 40-80 years;
- Ischemic cerebrovascular event onset, if any, must be within 6 months;
- TCD and carotid ultrasound exclude vascular narrow that can cause hemodynamic changes (usually >50% narrow lumen);
- MRI confirmed the presence of lacunar infarction and / or generalized white matter lesions;
- Written consent was obtained from the subject.
Key exclusion criteria (9 listed)
- History of intracranial hemorrhage;
- Significant bleeding from other parts of the body;
- History of atrial fibrillation;
- History of myocardial infarction within six months;
- Moyamoya disease or vasculitis;
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 preconditioningRIPC consists of five 5-min cycles of right upper arm ischemia/reperfusion, induced by an automated cuff-inflator placed on the right upper arm which is inflated to 200 mmHg for 5mins followed by deflating the cuff for 5mins, each patient in the RIPC group will have the treatment twice a day for two weeks. | Procedure or surgery | remote ischemic preconditioning |
| sham remote ischemic preconditioningSham RIPC consists of five 5-min cycles of right upper arm ischemia/reperfusion, induced by an automated cuff-inflator placed on the right upper arm which is inflated to 50 mmHg for 5mins followed by deflating the cuff for 5mins, each patient in the placebo RIPC group will have the treatment twice a day for two weeks. | Procedure or surgery | placebo remote ischemic preconditioning |
Primary outcome
changes in brain lesions
Time frame: 0-24 months
Volumetric MRI will be used for calculating changes in the number of lacunar infarctions and the total volume of white matter lesions
2 secondary outcomes
Changes in the cognitive function
Time frame: 0-24 months
Changes in the cerebral blood perfusion
Time frame: 0-24 months
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 26 Nov 2014.
- Derived from this study: PubMed 29042490Wang Y, Meng R, Song H, Liu G, Hua Y, Cui D, Zheng L, Feng W, Liebeskind DS, Fisher M, Ji X. Remote Ischemic Conditioning May Improve Outcomes of Patients With Cerebral Small-Vessel Disease. Stroke. 2017 Nov;48(11):3064-3072. doi: 10.1161/STROKEAHA.117.017691. Epub 2017 Oct 17.
- Derived from this study: PubMed 27351719Mi T, Yu F, Ji X, Sun Y, Qu D. The Interventional Effect of Remote Ischemic Preconditioning on Cerebral Small Vessel Disease: A Pilot Randomized Clinical Trial. Eur Neurol. 2016;76(1-2):28-34. doi: 10.1159/000447536. Epub 2016 Jun 29.
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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.
Xunming Ji, M.D., Ph.D. principal investigator
Xuan Wu Hospital of Capital Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing remote ischemic preconditioning in people with Cerebral Small Vessel Disease, run by Capital Medical University at 1 site in China.
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 5 inclusion and 9 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 26 Nov 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
changes in brain lesions (time frame: 0-24 months). 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 NCT01658306, which also lists 2 linked publications.
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 26 Nov 2014.