Moyamoya DiseaseRIC-IMDNCT04917003
Safety and Efficacy of Remote Ischemic Conditioning Combined EDAS on Ischemic Moyamoya Disease
A study testing RIC plus EDAS and EDAS in people with Moyamoya Disease, run by Capital Medical University at 1 site in China.
Trial summary
Encephaloduroarteriosynangiosis (EDAS) is widely used as an indirect technique for treatment of moyamoya disease. Nevertheless, this indirect surgery tends to establish insufficient collateral circulation in most adult MMD patients. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Moyamoya Disease
- What is being tested?
- RIC plus EDAS and EDAS
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteChina
- Study dates
- 15 Jun 2021to 30 Jun 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 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subjects who were diagnosed as moyamoya disease by the diagnostic criteria recommended by the Research Committee on MMD of the Ministry of Health and Welfare of Japan in 2012.
- Suzuki stage: 2-5 stage
- Age: between 18 and 65 years old
- Subjects present with ischemic stroke or transient ischemic attack.
- Subjects who plan to accept the first EDAS surgery.
- Informed consent obtained from patient or patient's surrogate
Who cannot join
- Acute ischemic stroke occurred within one month.
- Suffered Intracranial hemorrhage before
- Subjects with large infarction spread widely over the territory of a main arterial trunk
- Aneurysms in the main arterial trunk
- Severe cardiac diseases like atrial fibrillation，valvular disease，heart failure, infective endocarditis and so on.
- Malignant tumors or severe disordered function of the heart, lung, liver or kidney.
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- Severe hemostatic disorder or severe coagulation dysfunction.
- Uncontrolled diabetes mellitus with a serum fasting blood glucose level>300 mg/dL, or requires insulin; hypertension with a systolic blood pressure over 180 mmHg or a diastolic blood pressure over 110 mmHg.
- Severe injury on upper limbs.
- Pregnant or lactating women.
- Life expectancy is less than 3 years.
- Patients who are not suitable for this trial considered by researchers for other reasons
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
The 307th Hospital of the Chinese People's Liberation Army
Beijing, 100071
About this study
Official title: Safety and Efficacy of Remote Ischemic Conditioning Combined Encephaloduroarteriosynangiosis（EDAS）on Ischemic Moyamoya Disease: A Prospective, Randomized, Controlled Study
Encephaloduroarteriosynangiosis (EDAS) is widely used as an indirect technique for treatment of moyamoya disease. Nevertheless, this indirect surgery tends to establish insufficient collateral circulation in most adult MMD patients. Nowadays, there is a lack of adjuvant therapies for improving collateral circulation induced by indirect revascularization. This study aims to explore whether remote ischemic conditioning can improve the collateral circulation after indirect revascularization.
Read the detailed description
Encephaloduroarteriosynangiosis (EDAS) is widely used as an indirect technique for treatment of moyamoya disease. Nevertheless, this indirect surgery tends to establish insufficient collateral circulation in most adult MMD patients. Nowadays, there is a lack of adjuvant therapies for improving collateral circulation induced by indirect revascularization. Remote ischemic conditioning (RIC) is a noninvasive approach protecting the brain by inflating and deflating blood-pressure cuff placed on the upper limbs. It has been confirmed to improve cerebral perfusion by promoting angiogenesis and arteriogenesis in ischemic animal brain. In addition, daily remote ischemic conditioning is a promising technique to ameliorate chronic cerebrovascular disease like intracranial atherosclerotic stenosis, small-vessel disease.
Thus, this study aims to explore whether remote ischemic conditioning can improve the collateral circulation after indirect revascularization.
- Conditions
- Moyamoya Disease
- Being tested
- RIC plus EDAS, EDAS
- Keywords
- moyamoya disease, EDAS, 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.
RIC plus EDASOther
Patients who are allocated into RIC group will undergo EDAS surgery combined 3-month RIC treatment. The opposite operation will be performed at 3 months after the first operation.
EDASOther
Patients who are allocated into the control group will accept EDAS surgery twice. The second operation will be performed at 3 months after the first operation.
| Study group | Role | What they receive |
|---|---|---|
| RIC group | Experimental | Patients who are allocated into RIC group will undergo the first EDAS surgery combined 3-month remote ischemic conditioning (RIC) treatment. The opposite operation will be performed at 3 months after the first operation.
RIC is a non-invasive therapy that performed by an electric auto-control 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.
EDAS involves placement of an external carotid artery branch beneath the dura in the ischemic territories. The superficial temporal artery (STA) was commonly used. Receives: Other: RIC plus EDAS |
| control group | Other | Patients who are allocated into the control group will accept EDAS surgery twice. The second operation will be performed at 3 months after the first operation.
EDAS involves placement of an external carotid artery branch beneath the dura in the ischemic territories. The superficial temporal artery (STA) was commonly used. Under certain circumstances, depending on the territory at risk, the occipital artery was also used. The donor vessel with the strip of galea (the arterial bridge) was detached from the pericranium or the fascia below, and two burr holes are made beneath the proximal and distal ends of the arterial bridge. The burr holes, with an average size of 3.0 × 8.0 cm, were connected by mill to make an oval bone flap and the dura was exposed. The target artery was then sewn to the dura using 10-0 Prolene suture. The bone flap was closed after cutting out the entry and exit sites for the target artery. Receives: Other: EDAS |
What is being measured
The primary outcome is the main question the study is designed to answer.
rCBF changed ratio at operative side
Cerebral blood flow will be evaluated by dynamic susceptibility contrast-MRI examination，and relative cerebral blood flow(rCBF) changed ratio will be calculated by the formula: (rCBF in MCA territory/rCBF in cerebellum after treatment - rCBF in MCA territory/rCBF in cerebellum before treatment )/ rCBF in MCA territory/rCBF in cerebellum before treatment (the operative side). The higher value of rCBF improvement ratio means better imaging outcome.
Measured: From baseline to 3 months.
Secondary outcomes (10)
the change of TTP delay at operative side
Time to peak(TTP) will be evaluated by dynamic susceptibility contrast-MRI examination. The improvement of TTP delay at operative side will be calculated by the formula: the change of TTP delay =TTP delay in MCA territory before treatment - TTP delay in MCA territory after treatment (the operative side). The higher value means better imaging outcome.
Measured: From baseline to 3 months.
rCBF changed ratio at non-operative side
Cerebral blood flow will be evaluated by dynamic susceptibility contrast-MRI examination，and relative cerebral blood flow(rCBF) changed ratio will be calculated by the formula: (rCBF in MCA territory/rCBF in cerebellum after treatment - rCBF in MCA territory/rCBF in cerebellum before treatment )/ rCBF in MCA territory/rCBF in cerebellum before treatment (the non-operative side). The higher value of rCBF improvement ratio means better imaging outcome.
Measured: From baseline to 3 months.
the change of TTP delay at non-operative side
Time to peak(TTP) will be evaluated by dynamic susceptibility contrast-MRI examination. The improvement of TTP delay at non-operative side will be calculated by the formula: Improvement of TTP delay =TTP delay in MCA territory before treatment - TTP delay in MCA territory after treatment (the non-operative side). The higher value means better imaging outcome.
Measured: From baseline to 3 months.
Incidence of major adverse cerebral event ( MACE)
MACE contains ischemic or hemorrhagic stroke, crescendo TIAs evaluated by registered Neurologists.
Measured: From baseline to 3 months.
The change of luminal area of superficial temporal artery
The luminal area of STA can reflect the angiogenesis induced by EDAS to some extent, and it will be measured by TOF-MRA.
Measured: From baseline to 3 months.
The degree of the collaterals from superficial temporal artery
The degree of the collaterals from superficial temporal artery will be evaluated by Transcranial Doppler ultrasound performed by an experienced technician. 0 for no collaterals from STA, 1 for little collaterals from STA, 2 for good collaterals from STA .
Measured: From baseline to 3 months.
Volume of regions with hyperintense signal
Volume of regions with hyperintense signal where the maximum dimension should be larger than 8mm will be measured at axial T2, fluid-attenuated inversion recovery.
Measured: From baseline to 3 months.
Number of regions with hyperintense signal
Number of regions with hyperintense signal will be counted at axial T2, fluid-attenuated inversion recovery.
Measured: From baseline to 3 months.
RIC related Adverse events
Adverse events related to RIC treatment, such as local edema, erythema, skin lesions of the arms.
Measured: From baseline to 3 months.
Flow velocity of superficial temporal artery at operative side
Flow velocity of superficial temporal artery at operative side will be evaluated by Transcranial Doppler ultrasound performed by an experienced technician.
Measured: From baseline to 3 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jun 2021
- Study start15 Jun 2021
- Primary completion30 Jun 2022 (estimated)
- Study completion30 Jun 2022 (estimated)
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
- 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
- Collaborators
- Beijing 302 Hospital
- Responsible party
- Principal investigator, Ji Xunming,MD,PhD, Capital Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04917003
- Sponsor's protocol ID
- RIC-IMD
- Acronym
- RIC-IMD
- Status last verified
- Jun 2021
- First submitted
- 1 Jun 2021
- Last updated
- 29 Jun 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Efficacy of Remote Ischemic Conditioning Combined Encephaloduroarteriosynangiosis（EDAS）on Ischemic Moyamoya Disease: A Prospective, Randomized, Controlled Study
- ClinicalTrials.gov ID
- NCT04917003
- Acronym / sponsor ID
- RIC-IMD / RIC-IMD
- Conditions
- Moyamoya Disease
- Keywords
- moyamoya disease, EDAS, remote ischemic conditioning, cerebral blood flow
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Capital Medical UniversityUniversity, hospital or other
- Collaborators
- Beijing 302 Hospital
- Study start
- 15 Jun 2021 (actual)
- Primary completion
- 30 Jun 2022 (estimated)
- Study completion
- 30 Jun 2022 (estimated)
- First posted
- 8 Jun 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.
Encephaloduroarteriosynangiosis (EDAS) is widely used as an indirect technique for treatment of moyamoya disease. Nevertheless, this indirect surgery tends to establish insufficient collateral circulation in most adult MMD patients. Nowadays, there is a lack of adjuvant therapies for improving collateral circulation induced by indirect revascularization. This study aims to explore whether remote ischemic conditioning can improve the collateral circulation after indirect revascularization.
Detailed description
Encephaloduroarteriosynangiosis (EDAS) is widely used as an indirect technique for treatment of moyamoya disease. Nevertheless, this indirect surgery tends to establish insufficient collateral circulation in most adult MMD patients. Nowadays, there is a lack of adjuvant therapies for improving collateral circulation induced by indirect revascularization. Remote ischemic conditioning (RIC) is a noninvasive approach protecting the brain by inflating and deflating blood-pressure cuff placed on the upper limbs. It has been confirmed to improve cerebral perfusion by promoting angiogenesis and arteriogenesis in ischemic animal brain. In addition, daily remote ischemic conditioning is a promising technique to ameliorate chronic cerebrovascular disease like intracranial atherosclerotic stenosis, small-vessel disease.
Thus, this study aims to explore whether remote ischemic conditioning can improve the collateral circulation after indirect revascularization.
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 | Other: RIC plus EDASPatients who are allocated into RIC group will undergo the first EDAS surgery combined 3-month remote ischemic conditioning (RIC) treatment. The opposite operation will be performed at 3 months after the first operation. RIC is a non-invasive therapy that performed by an electric auto-control 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. EDAS involves placement of an external carotid artery branch beneath the dura in the ischemic territories. The superficial temporal artery (STA) was commonly used. |
| control group | Other | Other: EDASPatients who are allocated into the control group will accept EDAS surgery twice. The second operation will be performed at 3 months after the first operation. EDAS involves placement of an external carotid artery branch beneath the dura in the ischemic territories. The superficial temporal artery (STA) was commonly used. Under certain circumstances, depending on the territory at risk, the occipital artery was also used. The donor vessel with the strip of galea (the arterial bridge) was detached from the pericranium or the fascia below, and two burr holes are made beneath the proximal and distal ends of the arterial bridge. The burr holes, with an average size of 3.0 × 8.0 cm, were connected by mill to make an oval bone flap and the dura was exposed. The target artery was then sewn to the dura using 10-0 Prolene suture. The bone flap was closed after cutting out the entry and exit sites for the target artery. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Subjects who were diagnosed as moyamoya disease by the diagnostic criteria recommended by the Research Committee on MMD of the Ministry of Health and Welfare of Japan in 2012.
- Suzuki stage: 2-5 stage
- Age: between 18 and 65 years old
- Subjects present with ischemic stroke or transient ischemic attack.
- Subjects who plan to accept the first EDAS surgery.
Key exclusion criteria (12 listed)
- Acute ischemic stroke occurred within one month.
- Suffered Intracranial hemorrhage before
- Subjects with large infarction spread widely over the territory of a main arterial trunk
- Aneurysms in the main arterial trunk
- Severe cardiac diseases like atrial fibrillation，valvular disease，heart failure, infective endocarditis and so on.
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 |
|---|---|---|
| RIC plus EDASPatients who are allocated into RIC group will undergo EDAS surgery combined 3-month RIC treatment. The opposite operation will be performed at 3 months after the first operation. | Other | RIC group |
| EDASPatients who are allocated into the control group will accept EDAS surgery twice. The second operation will be performed at 3 months after the first operation. | Other | control group |
Primary outcome
rCBF changed ratio at operative side
Time frame: From baseline to 3 months.
Cerebral blood flow will be evaluated by dynamic susceptibility contrast-MRI examination，and relative cerebral blood flow(rCBF) changed ratio will be calculated by the formula: (rCBF in MCA territory/rCBF in cerebellum after treatment - rCBF in MCA territory/rCBF in cerebellum before treatment )/ rCBF in MCA territory/rCBF in cerebellum before treatment (the operative side). The higher value of rCBF improvement ratio means better imaging outcome.
10 secondary outcomes
the change of TTP delay at operative side
Time frame: From baseline to 3 months.
rCBF changed ratio at non-operative side
Time frame: From baseline to 3 months.
the change of TTP delay at non-operative side
Time frame: From baseline to 3 months.
Incidence of major adverse cerebral event ( MACE)
Time frame: From baseline to 3 months.
The change of luminal area of superficial temporal artery
Time frame: From baseline to 3 months.
The degree of the collaterals from superficial temporal artery
Time frame: From baseline to 3 months.
Volume of regions with hyperintense signal
Time frame: From baseline to 3 months.
Number of regions with hyperintense signal
Time frame: From baseline to 3 months.
RIC related Adverse events
Time frame: From baseline to 3 months.
Flow velocity of superficial temporal artery at operative side
Time frame: From baseline to 3 months.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jun 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.
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 plus EDAS and EDAS 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 6 inclusion and 12 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 29 Jun 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 Xunming Ji, PhD (861013120136877, jixunming@vip.163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
rCBF changed ratio at operative side (time frame: From baseline to 3 months.). 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 29 Jun 2021; AzTrials last refreshed its copy on 7 Nov 2026.