Moyamoya DiseaseRIC-AMDNCT04012268
The Safety and Efficacy of RIC on Adult Moyamoya Disease
A study testing RIC and Aspirin in people with Moyamoya Disease, run by Capital Medical University at 1 site in China.
Trial summary
There are a series of symptoms such as ischemic stroke、transient ischemic attack 、hemorrhagic stroke、headache 、seizure and so on in moyamoya disease( MMD) patients .Nowadays, revascularization is the only effective way for ischemic MMD and there is no effective conservative treatment for MMD. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Moyamoya Disease
- What is being tested?
- RIC and Aspirin
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteChina
- Study dates
- 15 Jul 2019to 2 Feb 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 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Age: 18-60 years
- All of the patients underwent digital subtraction angiography (DSA) and met the current diagnostic criteria recommended by the Research Committee on MMD of the Ministry of Health and Welfare of Japan in 2012.
- mRs≤3
- Informed consent obtained from patient or acceptable patient's surrogate.
Who cannot join
- Patients with acute ischemic or hemorrhagic stroke within 3 months.
- Severe hepatic or renal dysfunction.
- Severe hemostatic disorder or severe coagulation dysfunction.
- Severe cardiac diseases.
- Patients with severe existing neurological or psychiatric disease
- Patients with moyamoya syndrome caused by autoimmune disease, Down syndrome , neurofibromatosis, leptospiral infection, or previous skull-base radiation therapy.
- Patients have been done or plan to accept revascularization surgery.
Trial locations and contacts
1 site in 1 country.
China1 site
Xuanwu Hospital, Capital Medical University
Beijing, Beijing Municipality, 100053
About this study
Official title: The Safety and Effect of Remote Ischemic Conditioning on Adult Moyamoya Disease
There are a series of symptoms such as ischemic stroke、transient ischemic attack 、hemorrhagic stroke、headache 、seizure and so on in moyamoya disease( MMD) patients .Nowadays, revascularization is the only effective way for ischemic MMD and there is no effective conservative treatment for MMD. This study was to explore the safety and efficacy of remote ischemic conditioning(RIC ) on adult MMD patients.
Read the detailed description
There are a series of symptoms such as ischemic stroke、transient ischemic attack 、hemorrhagic stroke、headache 、seizure and so on in moyamoya disease. Nowadays, revascularization is the only effective way for ischemic MMD while controversial for hemorrhagic MMD patients. Surgical complications including hyperperfusion syndrome, cerebral infarction or bleeding often occurred postoperatively. There is no effective conservative treatment for MMD up to now.
Remote ischemic conditioning is Remote ischemic conditioning (RIC) is a noninvasive and easy-to-use neuroprotective strategy, and it has potential effects on preventing ischemia reperfusion injury and ischemic infarction.This study was to explore the safety and efficacy of remote ischemic conditioning on adult MMD patients.
- Conditions
- Moyamoya Disease
- Being tested
- RIC, Aspirin
- Keywords
- moyamoya disease, remote ischemic conditioning, cerebral blood flow
- Medical subject headings
- Moyamoya Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RICDevice
Patients allocated to the RIC group will undergo RIC procedure during which bilateral arm cuffs are inflated to a pressure of 50 mmHg over systolic blood pressure for five cycles of 5 min followed by 5 min of relaxation of the cuffs.
AspirinDrug
patients will accept medication guided by neurologists
| Study group | Role | What they receive |
|---|---|---|
| RIC group | Experimental | Patients allocated to the RIC group will undergo RIC procedure during which bilateral arm cuffs are inflated to a pressure of 50 mmHg over systolic blood pressure for five cycles of 5 min followed by 5 min of relaxation of the cuffs. They will also accept medication treatment by professional neurologists. Receives: Device: RIC |
| Medication group | Other | Patients allocated to Medication group will accept medication treatment by professional neurologists. Receives: Drug: Aspirin |
What is being measured
The primary outcome is the main question the study is designed to answer.
improvement ratio of mean cerebral blood flow
Cerebral blood flow refers to the flow of blood through a certain cross-sectional area of cerebrovascular in a unit time. Patients' CBF will be detected by arterial spin labeling. In each hemisphere, middle cerebral artery territory was divided into ten regions according to Albert Stroke Program Early CT score (ASPECTS), regions of interest (ROI) were drawn manually in each of territory of MCA to determine the absolute CBF values. improvement ratio of mean CBF= mCBF atter treatment-mCBF baseline/mCBF baseline.
Measured: change from the baseline to12 months after treatment
Secondary outcomes (10)
incidence of ischemic stroke
ischemic stroke is diagnosed by symptoms of neurologic deficit or head CT and MRI.
Measured: from the baseline to 12 months after treatment
incidence of transient ischemic attack
TIA is diagnosed by patients' transient neurologic deficit
Measured: from the baseline to 12 months after treatment
incidence of hemorrhagic stroke
hemorrhagic stroke is diagnosed by head CT
Measured: from the baseline to 12 months after treatment
The level of matrix metalloproteinase 9 (MMP-9)
Blood samples will be drawn from cubital vein to test these biomarkersThese samples will be centrifuged immediately after collection and stored at - 80 until batch evaluation
Measured: change from the baseline to 3, 6, 12 months after treatment
The level of vascular endothelial growth factor
Blood samples will be drawn from cubital vein to test these biomarkersThese samples will be centrifuged immediately after collection and stored at - 80 until batch evaluation
Measured: change from the baseline to 3, 6, 12 months after treatment
The level of basic fibroblast growth factor
Blood samples will be drawn from cubital vein to test these biomarkersThese samples will be centrifuged immediately after collection and stored at - 80 until batch evaluation
Measured: change from the baseline to 3, 6 ,12 months after treatment
The rate of death and adverse event
All causes of death will be included to compute mortality at 12 months after therapy
Measured: change from the baseline to 12 months after treatment
The number of patients with erythema,and/or skin lesions related to RIC
Professional doctors will check it and the investigator will record the number.
Measured: change from the baseline to 12 months after treatment
The number of patients not tolerating RIC procedure,and refuse to continue the RIC procedure
the investigator will record the number.
Measured: change from the baseline to 12 months after treatment
The rate of progression of stenosis or occlusion at Willis circle
Progression of stenosis or occlusion at Willis circle was evaluated by TOF-MRA, which was defined as the the stenosis or occlusion was progressed to another part of Willis circle, like stenosis progressed from M1 to M2-M4 et al, or in the same part, stenosis progressed to occlusion.
Measured: 12 months after therapy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jul 2019
- Study start15 Jul 2019
- Primary completion10 Nov 2020
- Study completion2 Feb 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Moyamoya 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 N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 30 participants (actual)
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
- NCT04012268
- Sponsor's protocol ID
- RIC-AMD
- Acronym
- RIC-AMD
- Status last verified
- Mar 2021
- First submitted
- 3 Jul 2019
- Last updated
- 12 Mar 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Safety and Effect of Remote Ischemic Conditioning on Adult Moyamoya Disease
- ClinicalTrials.gov ID
- NCT04012268
- Acronym / sponsor ID
- RIC-AMD / RIC-AMD
- Conditions
- Moyamoya Disease
- Keywords
- moyamoya disease, remote ischemic conditioning, cerebral blood flow
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Capital Medical UniversityUniversity, hospital or other
- Study start
- 15 Jul 2019 (actual)
- Primary completion
- 10 Nov 2020 (actual)
- Study completion
- 2 Feb 2021 (actual)
- First posted
- 9 Jul 2019 (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.
There are a series of symptoms such as ischemic stroke、transient ischemic attack 、hemorrhagic stroke、headache 、seizure and so on in moyamoya disease( MMD) patients .Nowadays, revascularization is the only effective way for ischemic MMD and there is no effective conservative treatment for MMD. This study was to explore the safety and efficacy of remote ischemic conditioning(RIC ) on adult MMD patients.
Detailed description
There are a series of symptoms such as ischemic stroke、transient ischemic attack 、hemorrhagic stroke、headache 、seizure and so on in moyamoya disease. Nowadays, revascularization is the only effective way for ischemic MMD while controversial for hemorrhagic MMD patients. Surgical complications including hyperperfusion syndrome, cerebral infarction or bleeding often occurred postoperatively. There is no effective conservative treatment for MMD up to now.
Remote ischemic conditioning is Remote ischemic conditioning (RIC) is a noninvasive and easy-to-use neuroprotective strategy, and it has potential effects on preventing ischemia reperfusion injury and ischemic infarction.This study was to explore the safety and efficacy of remote ischemic conditioning on adult MMD patients.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| RIC group | Experimental | Device: RICPatients allocated to the RIC group will undergo RIC procedure during which bilateral arm cuffs are inflated to a pressure of 50 mmHg over systolic blood pressure for five cycles of 5 min followed by 5 min of relaxation of the cuffs. They will also accept medication treatment by professional neurologists. |
| Medication group | Other | Drug: AspirinPatients allocated to Medication group will accept medication treatment by professional neurologists. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Age: 18-60 years
- All of the patients underwent digital subtraction angiography (DSA) and met the current diagnostic criteria recommended by the Research Committee on MMD of the Ministry of Health and Welfare of Japan in 2012.
- mRs≤3
- Informed consent obtained from patient or acceptable patient's surrogate.
Key exclusion criteria (7 listed)
- Patients with acute ischemic or hemorrhagic stroke within 3 months.
- Severe hepatic or renal dysfunction.
- Severe hemostatic disorder or severe coagulation dysfunction.
- Severe cardiac diseases.
- Patients with severe existing neurological or psychiatric disease
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 |
|---|---|---|
| RICPatients allocated to the RIC group will undergo RIC procedure during which bilateral arm cuffs are inflated to a pressure of 50 mmHg over systolic blood pressure for five cycles of 5 min followed by 5 min of relaxation of the cuffs. | Device | RIC group |
| Aspirinpatients will accept medication guided by neurologists | Drug | Medication group |
Primary outcome
improvement ratio of mean cerebral blood flow
Time frame: change from the baseline to12 months after treatment
Cerebral blood flow refers to the flow of blood through a certain cross-sectional area of cerebrovascular in a unit time. Patients' CBF will be detected by arterial spin labeling. In each hemisphere, middle cerebral artery territory was divided into ten regions according to Albert Stroke Program Early CT score (ASPECTS), regions of interest (ROI) were drawn manually in each of territory of MCA to determine the absolute CBF values. improvement ratio of mean CBF= mCBF atter treatment-mCBF baseline/mCBF baseline.
10 secondary outcomes
incidence of ischemic stroke
Time frame: from the baseline to 12 months after treatment
incidence of transient ischemic attack
Time frame: from the baseline to 12 months after treatment
incidence of hemorrhagic stroke
Time frame: from the baseline to 12 months after treatment
The level of matrix metalloproteinase 9 (MMP-9)
Time frame: change from the baseline to 3, 6, 12 months after treatment
The level of vascular endothelial growth factor
Time frame: change from the baseline to 3, 6, 12 months after treatment
The level of basic fibroblast growth factor
Time frame: change from the baseline to 3, 6 ,12 months after treatment
The rate of death and adverse event
Time frame: change from the baseline to 12 months after treatment
The number of patients with erythema,and/or skin lesions related to RIC
Time frame: change from the baseline to 12 months after treatment
The number of patients not tolerating RIC procedure,and refuse to continue the RIC procedure
Time frame: change from the baseline to 12 months after treatment
The rate of progression of stenosis or occlusion at Willis circle
Time frame: 12 months after therapy
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 12 Mar 2021.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing RIC and Aspirin in people with Moyamoya 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 4 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 12 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?
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?
improvement ratio of mean cerebral blood flow (time frame: change from the baseline to12 months after 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 12 Mar 2021.