Cerebral Small Vessel DiseasesRIC-SVDNCT04816500
Remote Ischemic Conditioning on Cerebral Small Vessel Disease
A study testing Automatic ischemic conditioning treatment instrument and Regular treatment in people with Cerebral Small Vessel Diseases, run by Capital Medical University at 1 site in China.
Trial summary
This trial is a randomized, controlled, single-center, double-blind trial. Cerebral small vessel disease (CSVD) patients will be recruited and randomized into RIC or control group.The protective effect of remote ischemic conditioning (RIC) on CSVD will be investigated. Read more about this study
- Who is it for?
- Ages 45 to 80 years
- Conditions the study is for
- Cerebral Small Vessel Diseases
- What is being tested?
- Automatic ischemic conditioning treatment instrument and Regular treatment
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2019to 31 Dec 2021
- 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 45 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 45-80 years old, and gender not limited;
- patient and/or caregiver report of cognitive declines with regard to memory and/or other cognitive domains lasting for at least 3 months;
- neither normal nor demented on the basis of the criteria of the Diagnostic and Statistical Manual of Mental Disorders (Fourth Edition) with normal or slightly impaired activities of daily living9, with Mini-mental State Examination (MMSE) score ≥ 20 (primary school) or ≥ 24 (junior school or above)10 and Montreal Cognitive Assessment (MoCA) score ≤ 26;
- the presence of lacunes and/or WMHs and/or CMBs on MRI
- absence of vascular narrowing >50% luminal diameter that could cause hemodynamic changes (MFV>90 cm/s for the intracranial internal carotid artery, 100 cm/s for MCA, >80 cm/s for basilar artery [BA] or vertebral artery) measured by TCD
Who cannot join
- clinical manifestations indicating that the patient was at the end-stage of cSVD;
- hereditary or inflammatory small vessel disorders
- cerebral venous injury or changes;
- diagnosis of nervous system degenerative diseases Alzheimer's disease, DLB, frontotemporal dementia (FTD), and so on;
- history of intracranial hemorrhage or significant bleeding in other parts of the body
- brain tumor, psychoses, or acute stroke within 6 months;
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- cardiogenic embolism;
- significant bleeding coagulation dysfunction;
- serious liver and kidney function is not complete, malignant tumor, or serious diseases need to medical intervention or surgery;
- any soft tissue or vascular injury, and any disease of the extremities that may contraindicate RIC;
- pregnant women;
- life expectancy<6 months;
- refused to sign a consent form, poor compliance, or not to cooperate to complete whole treatment, and so on.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Xuanwu hospital;Capital Medical University
Beijin
Xunming Ji, +86-10-83198952, jixunming@vip.163.com
About this study
Official title: Study of Efficacy and Safety of Remote Ischemic Conditioning on Cerebral Small Vessel Disease
This trial is a randomized, controlled, single-center, double-blind trial. Cerebral small vessel disease (CSVD) patients will be recruited and randomized into RIC or control group.The protective effect of remote ischemic conditioning (RIC) on CSVD will be investigated.
- Conditions
- Cerebral Small Vessel Diseases
- Being tested
- Automatic ischemic conditioning treatment instrument, Regular treatment
- Keywords
- Cerebral Small Vessel Diseases, Remote Ischemic Conditioning
- 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.
Automatic ischemic conditioning treatment instrumentDevice
RIC is a non-invasive therapy that performed by an electric autocontrol device with cuff placed on arm. RIC procedures consist of five cycles of 5-min inflation (200 mmHg) and 5-min deflation of cuff on one arm. The procedure will be performed twice daily for consecutive 1 year after enrollment.
Regular treatmentDrug
Antiplatelet agents and statins administration, vascular risk factors control.
| Study group | Role | What they receive |
|---|---|---|
| RIC group | Experimental | Device: Remote ischemic conditioning RIC is a non-invasive therapy that performed by an electric autocontrol device with cuff placed on arm. RIC procedures consist of five cycles of 5-min inflation (200 mmHg) and 5-min deflation of cuff on one arm. The procedure will be performed twice daily for consecutive 1 year after enrollment. Receives: Device: Automatic ischemic conditioning treatment instrument |
| Regular treatment | Other | Not described Receives: Drug: Regular treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes of volume of WMHs
The volume of WMHs was measured on Flairs and DTI. By calculating the mean diffusivity (MD) and FA of water diffusion, DTI can assess the integrity and connectivity of WM tissue from a network perspective, and reconstruct the distribution of WM pathways in the brain three-dimensionally.
Measured: From baseline to 1 year treatment
Secondary outcomes (2)
Changes in hemodynamic parameters on TCD.
The peak systolic, mean, and end diastolic blood flow velocities (BFV) at the most proximal segment of bilateral MCAs, BA were measured by TCD
Measured: From baseline to 1 year treatment
Changes of cognition evaluation on MoCA.
The Beijing version of MoCA were used to evaluate to evaluate the cognitive functions of patients, referring to the degree of an individual's capacity with respect to orientation, memory, calculation, language, execution and visuospatial function and so on
Measured: From baseline to 1 year treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Mar 2021
- Study start1 Jan 2019
- Primary completion1 Dec 2021 (estimated)
- Study completion31 Dec 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cerebral Small Vessel DiseasesStudies of the same condition, open and under way.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Capital Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ji Xunming,MD,PhD, Capital Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04816500
- Sponsor's protocol ID
- Capital Medical U
- Acronym
- RIC-SVD
- Status last verified
- Mar 2021
- First submitted
- 23 Mar 2021
- Last updated
- 25 Mar 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 25 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of Efficacy and Safety of Remote Ischemic Conditioning on Cerebral Small Vessel Disease
- ClinicalTrials.gov ID
- NCT04816500
- Acronym / sponsor ID
- RIC-SVD / Capital Medical U
- Conditions
- Cerebral Small Vessel Diseases
- Keywords
- Cerebral Small Vessel Diseases, Remote Ischemic Conditioning
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Capital Medical UniversityUniversity, hospital or other
- Study start
- 1 Jan 2019 (actual)
- Primary completion
- 1 Dec 2021 (estimated)
- Study completion
- 31 Dec 2021 (estimated)
- First posted
- 25 Mar 2021 (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.
This trial is a randomized, controlled, single-center, double-blind trial. Cerebral small vessel disease (CSVD) patients will be recruited and randomized into RIC or control group.The protective effect of remote ischemic conditioning (RIC) on CSVD will be investigated.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| RIC group | Experimental | Device: Automatic ischemic conditioning treatment instrumentDevice: Remote ischemic conditioning RIC is a non-invasive therapy that performed by an electric autocontrol device with cuff placed on arm. RIC procedures consist of five cycles of 5-min inflation (200 mmHg) and 5-min deflation of cuff on one arm. The procedure will be performed twice daily for consecutive 1 year after enrollment. |
| Regular treatment | Other | Drug: Regular treatment |
Who may qualify
- Ages
- 45 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 45-80 years old, and gender not limited;
- patient and/or caregiver report of cognitive declines with regard to memory and/or other cognitive domains lasting for at least 3 months;
- neither normal nor demented on the basis of the criteria of the Diagnostic and Statistical Manual of Mental Disorders (Fourth Edition) with normal or slightly impaired activities of daily living9, with Mini-mental State Examination (MMSE) score ≥ 20 (primary school) or ≥ 24 (junior school or above)10 and Montreal Cognitive Assessment (MoCA) score ≤ 26;
- the presence of lacunes and/or WMHs and/or CMBs on MRI
- absence of vascular narrowing >50% luminal diameter that could cause hemodynamic changes (MFV>90 cm/s for the intracranial internal carotid artery, 100 cm/s for MCA, >80 cm/s for basilar artery [BA] or vertebral artery) measured by TCD
Key exclusion criteria (13 listed)
- clinical manifestations indicating that the patient was at the end-stage of cSVD;
- hereditary or inflammatory small vessel disorders
- cerebral venous injury or changes;
- diagnosis of nervous system degenerative diseases Alzheimer's disease, DLB, frontotemporal dementia (FTD), and so on;
- history of intracranial hemorrhage or significant bleeding in other parts of the body
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 |
|---|---|---|
| Automatic ischemic conditioning treatment instrumentRIC is a non-invasive therapy that performed by an electric autocontrol device with cuff placed on arm. RIC procedures consist of five cycles of 5-min inflation (200 mmHg) and 5-min deflation of cuff on one arm. The procedure will be performed twice daily for consecutive 1 year after enrollment. | Device | RIC group |
| Regular treatmentAntiplatelet agents and statins administration, vascular risk factors control. | Drug | Regular treatment |
Primary outcome
Changes of volume of WMHs
Time frame: From baseline to 1 year treatment
The volume of WMHs was measured on Flairs and DTI. By calculating the mean diffusivity (MD) and FA of water diffusion, DTI can assess the integrity and connectivity of WM tissue from a network perspective, and reconstruct the distribution of WM pathways in the brain three-dimensionally.
2 secondary outcomes
Changes in hemodynamic parameters on TCD.
Time frame: From baseline to 1 year treatment
Changes of cognition evaluation on MoCA.
Time frame: From baseline to 1 year treatment
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Mar 2021.
- Individual participant dataSharing planned: Undecided
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Automatic ischemic conditioning treatment instrument and Regular treatment in people with Cerebral Small Vessel Diseases, 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 13 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: status not confirmed, as of the sponsor's last update on 25 Mar 2021. 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. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Yuan Wang, MD (+861083199085, wilma0106@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes of volume of WMHs (time frame: From baseline to 1 year treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 25 Mar 2021.