Moya Moya DiseaseNCT07889531
Efficacy and Safety of Ischemic Preconditioning Therapy Versus Optimal Medical Therapy in Reducing the Recurrence of Ischemic Events in Symptomatic Moyamoya Disease
A study testing Standard Remote Ischemic Preconditioning in people with Moya Moya Disease and Moyamoya Syndrome, run by Beijing Tiantan Hospital at 1 site in China.
Trial summary
This clinical trial aims to investigate whether remote ischemic conditioning (RIC) can reduce the risk of cerebral ischemic events, delay clinical progression, and improve long-term outcomes in patients with symptomatic Moyamoya disease (Moyamoya syndrome). Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Moya Moya Disease, Moyamoya Syndrome
- What is being tested?
- Standard Remote Ischemic Preconditioning
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 256 participants
- Where
- 1 siteChina
- Study dates
- 10 Oct 2026to 31 Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- The patient is aged between 18 and 70 years old;
- There is evidence from MRA, CTA or DSA, and the patient is professionally diagnosed with moyamoya disease or moyamoya syndrome;
- The patient has ischemic symptoms related to moyamoya vasculopathy, including transient ischemic attack (TIA) and cerebral infarction (limb weakness, hemiplegia, paresthesia, speech disorder, etc. The symptoms may recur in the unilateral limb, or progress to bilateral attacks or alternating bilateral attacks);
- After clinical evaluation, non-surgical treatment strategies such as drug therapy and risk factor management are planned to be adopted currently, and the patient is not planned to undergo cerebral blood flow revascularization within 6 months after randomization during screening;
- The patient has signed the informed consent form.
Who cannot join
- History of intracranial hemorrhage (such as subarachnoid hemorrhage, cerebral parenchymal hemorrhage and intraventricular hemorrhage) and other cerebrovascular diseases (such as intracranial aneurysm, cerebral arteriovenous malformation, arteriovenous fistula, etc.);
- History of brain tumor, severe craniocerebral trauma, encephalitis, meningitis and other central nervous system inflammatory diseases, or other major craniocerebral diseases, any form of invasive brain treatment history and radiotherapy history;
- Presence of severe or uncontrolled systemic diseases, or vital organ dysfunction that the investigator judges may significantly increase the subject's research risk or affect the completion of follow-up, including but not limited to severe cardiac insufficiency (ejection fraction <50% or NYHA class III-IV cardiac function), severe liver function abnormality (such as ALT or AST > 2 times the upper limit of normal value), severe renal insufficiency (such as serum creatinine > 3 mg/dL), severe or uncontrolled respiratory diseases, severe non-cardiovascular comorbidities with expected survival time <1 year;
- There is a clear source of cardiogenic embolism, including rheumatic mitral or aortic valve stenosis, prosthetic valve, atrial fibrillation, atrial flutter, sick sinus syndrome, left atrial myxoma, patent foramen ovale, left ventricular mural thrombus, valve vegetation, congestive heart failure, bacterial endocarditis, or other cardiovascular diseases that affect study participation;
- Uncontrolled severe hypertension, that is, seated systolic blood pressure >180 mmHg and/or diastolic blood pressure >110 mmHg after drug treatment;
- Severe hemostatic disorder or severe coagulation dysfunction;
- Contraindications to RIC treatment:
- Combined with upper extremity peripheral vascular disease or those judged by the investigator to be unsuitable for upper arm cuff compression, especially vascular lesions that may increase the risk of upper extremity ischemia, including known moderate to severe stenosis or occlusion of the subclavian artery, axillary artery, brachial artery, radial artery or ulnar artery, subclavian steal syndrome, and obvious symptoms of upper extremity ischemia; (2) There are local upper extremity conditions that may affect the safe implementation of RIC, including severe skin or soft tissue infection, skin breakage, unhealed wounds, recent upper extremity trauma or fracture, obvious hematoma, severe edema or lymphedema, arteriovenous fistula or hemodialysis access, PICC or other vascular access not suitable for compression, recent upper extremity deep vein thrombosis or thrombophlebitis, etc.; (3) Known history of allergy to RIC equipment or its constituent materials 8. Patients who refuse follow-up or cannot communicate due to severe mental illness; 9. Unfit for taVNS wearing due to skin breakage, infection, redness and swelling at the wearing site; 10. Pregnant and lying-in women; 11. Participate in other studies at the same period.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Titan Hospital; Capital Medical University
Beijing, Beijing Municipality
About this study
Official title: A Study on the Efficacy and Safety of Remote Ischemic Conditioning Therapy Versus Optimal Medical Therapy in Reducing the Recurrence of Ischemic Events in Symptomatic Moyamoya Disease
This clinical trial aims to investigate whether remote ischemic conditioning (RIC) can reduce the risk of cerebral ischemic events, delay clinical progression, and improve long-term outcomes in patients with symptomatic Moyamoya disease (Moyamoya syndrome). The primary research questions include:
Does RIC lower the incidence of cerebral ischemic events (e.g., stroke, transient ischemic attack) compared to standard care? Does RIC slow disease progression, as measured by neuroimaging markers (e.g., cerebral blood flow, collateral vessel development) and clinical assessments? Does RIC improve long-term functional outcomes (e.g., modified Rankin Scale, quality of life) in this patient population? Study Design This is a multicenter, prospective, double-blind, randomized controlled trial (RCT). Eligible participants who provide informed consent and complete baseline evaluations will be dynamically randomized (1:1) via a central randomization system using the minimization method to either the intervention group or the control group.
Read more
Intervention Group: Patients will receive RIC therapy (using an automated device) in addition to optimal medical treatment (OMT). RIC will be administered twice daily for 6 months, with each session consisting of 5 cycles of bilateral upper-limb cuff inflation (5 min at a preset high pressure) followed by deflation (5 min), totaling ~45 min per session. OMT includes antiplatelet agents, antihypertensives, antidiabetics, and lipid-lowering drugs as clinically indicated.
Control Group: Patients will receive a sham RIC procedure (using the same device but with cuffs inflated to a fixed low pressure of 60 mmHg) alongside identical OMT. The frequency, duration, and cycling protocol will match those of the intervention group.
- Conditions
- Moya Moya Disease, Moyamoya Syndrome
- Being tested
- Standard Remote Ischemic Preconditioning, Sham Remote Ischemic Preconditioning
- Medical subject headings
- Moyamoya Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Standard Remote Ischemic PreconditioningDevice
Patients in the intervention group receive remote ischemic preconditioning (RIC) treatment on the basis of optimal medical therapy. Using a unified RIC device, the treatment is administered twice daily for a total duration of 6 months. Each session consists of 5 cycles: after bilateral upper arm blood pressure measurement, the upper arm cuffs are inflated to a preset high pressure (systolic blood pressure + 50 mmHg) for 5 minutes, followed by deflation for 5 minutes, with a total duration of approximately 45 minutes per session. The optimal medical therapy includes conventional treatments such as antiplatelet therapy, blood pressure control, glucose control, and lipid regulation.
Sham Remote Ischemic PreconditioningDevice
Patients in the control group receive sham remote ischemic preconditioning (RIC) treatment on the basis of optimal medical therapy. Using the same RIC device, after bilateral upper arm blood pressure measurement, the upper arm cuffs are inflated to 60 mmHg. The treatment frequency, total duration, cycling protocol, and definition of the optimal medical therapy regimen are completely consistent with those of the intervention group.
| Study group | Role | What they receive |
|---|---|---|
| Standard Remote Ischemic Preconditioning (RIC) Combined with Optimal Medical Therapy | Experimental | For the Experimental Arm: On the basis of guideline-recommended optimal medical therapy (including standardized risk factor management such as antiplatelet therapy, statin therapy, blood pressure control, glucose control, and lipid regulation), participants receive standard-parameter remote ischemic preconditioning (RIC) treatment: using a unified RIC device, twice daily for a total treatment course of 6 months; each treatment session consists of 5 cycles, with bilateral upper arm cuffs inflated to a preset high pressure (50 mmHg above the participant's baseline systolic blood pressure) for 5 minutes, followed by deflation for 5 minutes, with a total duration of approximately 45 minutes per session. Receives: Device: Standard Remote Ischemic Preconditioning |
| Sham Remote Ischemic Preconditioning (RIC) Combined with Optimal Medical Therapy Group | Sham comparator | For the Sham Comparator Arm: Participants receive an optimal medical therapy regimen identical to that of the experimental group, along with sham-parameter remote ischemic preconditioning (RIC) treatment: using the same RIC device as the experimental group, with treatment frequency, total course duration, cycling protocol, and operational procedures completely consistent with the experimental group; only the inflation pressure of the bilateral upper arm cuffs is set at 60 mmHg (no actual ischemic stimulation effect, only retaining the sensory experience of the procedure), and all operational processes are identical to the experimental group to ensure the validity of blinding. Receives: Device: Sham Remote Ischemic Preconditioning |
What is being measured
The primary outcome is the main question the study is designed to answer.
Ischemic cerebrovascular events within 180 days after intervention
Measured: one month; three months; six months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Oct 2026
- Study start10 Oct 2026
- Primary completion31 Dec 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Moya Moya DiseaseStudies of the same condition, open and under way.
- More trials run by Beijing Tiantan HospitalThe 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 256 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Beijing Tiantan Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Henan Provincial People's Hospital, The Fifth Medical Center of the PLA General Hospital, The First Affiliated Hospital of Zhengzhou University, The First Affiliated Hospital of Nanchang University
- Responsible party
- Principal investigator, Wang Shuo, Beijing Tiantan Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07889531
- Sponsor's protocol ID
- HX-A-2026080
- Status last verified
- Oct 2026
- First submitted
- 16 Oct 2026
- Last updated
- 28 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study on the Efficacy and Safety of Remote Ischemic Conditioning Therapy Versus Optimal Medical Therapy in Reducing the Recurrence of Ischemic Events in Symptomatic Moyamoya Disease
- ClinicalTrials.gov ID
- NCT07889531
- Acronym / sponsor ID
- HX-A-2026080
- Conditions
- Moya Moya Disease, Moyamoya Syndrome
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 256 participants (estimated)
- Lead sponsor
- Beijing Tiantan HospitalUniversity, hospital or other
- Collaborators
- Henan Provincial People's Hospital, The Fifth Medical Center of the PLA General Hospital, The First Affiliated Hospital of Zhengzhou University, The First Affiliated Hospital of Nanchang University
- Study start
- 10 Oct 2026 (actual)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 22 Oct 2026 (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 clinical trial aims to investigate whether remote ischemic conditioning (RIC) can reduce the risk of cerebral ischemic events, delay clinical progression, and improve long-term outcomes in patients with symptomatic Moyamoya disease (Moyamoya syndrome). The primary research questions include:
Does RIC lower the incidence of cerebral ischemic events (e.g., stroke, transient ischemic attack) compared to standard care? Does RIC slow disease progression, as measured by neuroimaging markers (e.g., cerebral blood flow, collateral vessel development) and clinical assessments? Does RIC improve long-term functional outcomes (e.g., modified Rankin Scale, quality of life) in this patient population? Study Design This is a multicenter, prospective, double-blind, randomized controlled trial (RCT). Eligible participants who provide informed consent and complete baseline evaluations will be dynamically randomized (1:1) via a central randomization system using the minimization method to either the intervention group or the control group.
Intervention Group: Patients will receive RIC therapy (using an automated device) in addition to optimal medical treatment (OMT). RIC will be administered twice daily for 6 months, with each session consisting of 5 cycles of bilateral upper-limb cuff inflation (5 min at a preset high pressure) followed by deflation (5 min), totaling ~45 min per session. OMT includes antiplatelet agents, antihypertensives, antidiabetics, and lipid-lowering drugs as clinically indicated.
Control Group: Patients will receive a sham RIC procedure (using the same device but with cuffs inflated to a fixed low pressure of 60 mmHg) alongside identical OMT. The frequency, duration, and cycling protocol will match those of the intervention group.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard Remote Ischemic Preconditioning (RIC) Combined with Optimal Medical Therapy | Experimental | Device: Standard Remote Ischemic PreconditioningFor the Experimental Arm: On the basis of guideline-recommended optimal medical therapy (including standardized risk factor management such as antiplatelet therapy, statin therapy, blood pressure control, glucose control, and lipid regulation), participants receive standard-parameter remote ischemic preconditioning (RIC) treatment: using a unified RIC device, twice daily for a total treatment course of 6 months; each treatment session consists of 5 cycles, with bilateral upper arm cuffs inflated to a preset high pressure (50 mmHg above the participant's baseline systolic blood pressure) for 5 minutes, followed by deflation for 5 minutes, with a total duration of approximately 45 minutes per session. |
| Sham Remote Ischemic Preconditioning (RIC) Combined with Optimal Medical Therapy Group | Sham comparator | Device: Sham Remote Ischemic PreconditioningFor the Sham Comparator Arm: Participants receive an optimal medical therapy regimen identical to that of the experimental group, along with sham-parameter remote ischemic preconditioning (RIC) treatment: using the same RIC device as the experimental group, with treatment frequency, total course duration, cycling protocol, and operational procedures completely consistent with the experimental group; only the inflation pressure of the bilateral upper arm cuffs is set at 60 mmHg (no actual ischemic stimulation effect, only retaining the sensory experience of the procedure), and all operational processes are identical to the experimental group to ensure the validity of blinding. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- The patient is aged between 18 and 70 years old;
- There is evidence from MRA, CTA or DSA, and the patient is professionally diagnosed with moyamoya disease or moyamoya syndrome;
- The patient has ischemic symptoms related to moyamoya vasculopathy, including transient ischemic attack (TIA) and cerebral infarction (limb weakness, hemiplegia, paresthesia, speech disorder, etc. The symptoms may recur in the unilateral limb, or progress to bilateral attacks or alternating bilateral attacks);
- After clinical evaluation, non-surgical treatment strategies such as drug therapy and risk factor management are planned to be adopted currently, and the patient is not planned to undergo cerebral blood flow revascularization within 6 months after randomization during screening;
- The patient has signed the informed consent form.
Key exclusion criteria (8 listed)
- History of intracranial hemorrhage (such as subarachnoid hemorrhage, cerebral parenchymal hemorrhage and intraventricular hemorrhage) and other cerebrovascular diseases (such as intracranial aneurysm, cerebral arteriovenous malformation, arteriovenous fistula, etc.);
- History of brain tumor, severe craniocerebral trauma, encephalitis, meningitis and other central nervous system inflammatory diseases, or other major craniocerebral diseases, any form of invasive brain treatment history and radiotherapy history;
- Presence of severe or uncontrolled systemic diseases, or vital organ dysfunction that the investigator judges may significantly increase the subject's research risk or affect the completion of follow-up, including but not limited to severe cardiac insufficiency (ejection fraction <50% or NYHA class III-IV cardiac function), severe liver function abnormality (such as ALT or AST > 2 times the upper limit of normal value), severe renal insufficiency (such as serum creatinine > 3 mg/dL), severe or uncontrolled respiratory diseases, severe non-cardiovascular comorbidities with expected survival time <1 year;
- There is a clear source of cardiogenic embolism, including rheumatic mitral or aortic valve stenosis, prosthetic valve, atrial fibrillation, atrial flutter, sick sinus syndrome, left atrial myxoma, patent foramen ovale, left ventricular mural thrombus, valve vegetation, congestive heart failure, bacterial endocarditis, or other cardiovascular diseases that affect study participation;
- Uncontrolled severe hypertension, that is, seated systolic blood pressure >180 mmHg and/or diastolic blood pressure >110 mmHg after drug treatment;
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 |
|---|---|---|
| Standard Remote Ischemic PreconditioningPatients in the intervention group receive remote ischemic preconditioning (RIC) treatment on the basis of optimal medical therapy. Using a unified RIC device, the treatment is administered twice daily for a total duration of 6 months. Each session consists of 5 cycles: after bilateral upper arm blood pressure measurement, the upper arm cuffs are inflated to a preset high pressure (systolic blood pressure + 50 mmHg) for 5 minutes, followed by deflation for 5 minutes, with a total duration of approximately 45 minutes per session. The optimal medical therapy includes conventional treatments such as antiplatelet therapy, blood pressure control, glucose control, and lipid regulation. | Device | Standard Remote Ischemic Preconditioning (RIC) Combined with Optimal Medical Therapy |
| Sham Remote Ischemic PreconditioningPatients in the control group receive sham remote ischemic preconditioning (RIC) treatment on the basis of optimal medical therapy. Using the same RIC device, after bilateral upper arm blood pressure measurement, the upper arm cuffs are inflated to 60 mmHg. The treatment frequency, total duration, cycling protocol, and definition of the optimal medical therapy regimen are completely consistent with those of the intervention group. | Device | Sham Remote Ischemic Preconditioning (RIC) Combined with Optimal Medical Therapy Group |
Primary outcome
Ischemic cerebrovascular events within 180 days after intervention
Time frame: one month; three months; six months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Oct 2026.
- Individual participant dataSharing planned: No
Related trials for Moya Moya Disease
RecruitingObservational study
Managing Transient Neurologic Episodes in Surgery for Moyamoya Disease
Moya Moya Disease
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Standard Remote Ischemic Preconditioning in people with Moya Moya Disease and Moyamoya Syndrome, run by Beijing Tiantan Hospital 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 8 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: looking for participants now, as of the sponsor's last update on 28 Oct 2026. 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.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Liu Qingyuan (+86 13260457220, 13260457220@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Ischemic cerebrovascular events within 180 days after intervention (time frame: one month; three months; six 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 28 Oct 2026.