An observational study in Moyamoya Disease and Moyamoya Syndrome, sponsored by Beijing Tiantan Hospital. Recruiting at 13 sites in China. Open to participants aged 12 Years to 70 Years. Per ClinicalTrials.gov, last updated 2026-10-26.
Sponsored by Beijing Tiantan Hospital · Observational
This multicenter prospective observational cohort study aims to develop and validate individualized risk prediction models for stroke and cognitive decline in patients with moyamoya disease or moyamoya syndrome by integrating clinical characteristics, laboratory data, multimodal neuroimaging, genetic information, and other available multidimensional data. Approximately 3,000 participants will be enrolled and followed for up to 24 months.
This is a multicenter prospective observational cohort study enrolling approximately 3,000 patients with moyamoya disease or moyamoya syndrome.
At baseline, demographic and clinical characteristics, neurological and cognitive assessments, laboratory data, multimodal neuroimaging, and peripheral blood samples will be collected according to the study protocol. Baseline vascular imaging will include at least one analyzable CTA, MRA, or DSA examination. Additional structural MRI and perfusion imaging, including CTP, ASL, or DSC, will be collected when available.
The study does not assign treatment. Participants will receive conservative management or cerebral revascularization according to their clinical condition, current standards of care, and shared decision-making between treating physicians and patients.
Participants will be followed at 3-6 months, 12 months, and 24 months after enrollment. The primary outcome is incident stroke within 24 months. Secondary outcomes include stroke at earlier time points, transient ischemic attack, functional deterioration, mortality, cognitive change assessed by the Montreal Cognitive Assessment, disease progression, and subsequent cerebral revascularization among participants initially managed conservatively.
Prediction models for ischemic stroke, intracerebral hemorrhage, and cognitive decline will be developed and validated using baseline clinical, imaging, laboratory, genetic, and other available multidimensional data. Twelve-month prediction and dynamically updated models will be considered secondary or exploratory analyses.
61 studies on the registry are indexed under Moyamoya Disease; 26 are open to participants now.
This study's planned enrollment of 3,000 is above the median of 120 across 29 observational studies indexed under Moyamoya Disease.
Browse Moyamoya Disease studies →Beijing Tiantan Hospital is the lead sponsor of 483 studies on the registry; 289 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Patients with moyamoya disease or moyamoya syndrome diagnosed by imaging criteria at participating centers.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria
Participants with moyamoya disease or moyamoya syndrome will be enrolled in a prospective observational cohort. Treatment is not assigned by the study protocol. Participants may receive conservative management or cerebral revascularization according to their clinical condition and routine clinical practice and will be followed for clinical, cognitive, imaging, and treatment outcomes for up to 24 months.
Incidence of stroke within 24 months after enrollment
Stroke is defined as symptomatic ischemic stroke or intracerebral hemorrhage occurring after enrollment. Suspected stroke events will be identified through scheduled or event-driven follow-up, telephone interviews, and review of hospitalization records and will be confirmed by brain CT or MRI whenever available. The outcome will be reported as the percentage of participants experiencing at least one incident stroke within 24 months after enrollment.
Time frame: From enrollment through 24 months
Incidence of stroke within 6 months after enrollment
Stroke is defined as symptomatic ischemic stroke or intracerebral hemorrhage occurring after enrollment and confirmed by clinical records and brain CT or MRI whenever available. The outcome will be reported as the percentage of participants experiencing at least one incident stroke within 6 months after enrollment.
Time frame: From enrollment through 6 months
Incidence of stroke within 12 months after enrollment
Stroke is defined as symptomatic ischemic stroke or intracerebral hemorrhage occurring after enrollment and confirmed by clinical records and brain CT or MRI whenever available. The outcome will be reported as the percentage of participants experiencing at least one incident stroke within 12 months after enrollment.
Time frame: From enrollment through 12 months
Incidence of transient ischemic attack within 24 months
Transient ischemic attack is defined as an acute focal neurological deficit attributable to cerebral ischemia that completely resolves within 24 hours without evidence of a new cerebral infarction on CT or MRI. The outcome will be reported as the percentage of participants experiencing at least one transient ischemic attack during follow-up.
Time frame: From enrollment through 24 months
Number of transient ischemic attack episodes within 24 months
The total number of protocol-defined transient ischemic attack episodes occurring in each participant during follow-up will be recorded. The outcome will be reported as the number of transient ischemic attack episodes per participant.
Time frame: From enrollment through 24 months
Incidence of disabling stroke within 24 months
Disabling stroke is defined as an incident stroke associated with a modified Rankin Scale score greater than 1, according to the study protocol. The outcome will be reported as the percentage of participants experiencing a disabling stroke.
Time frame: From enrollment through 24 months
Participants with an increase of at least 1 point in the modified Rankin Scale score at 6 months
Neurological disability will be assessed using the modified Rankin Scale, which ranges from 0 to 6, with higher scores indicating greater disability. The outcome will be reported as the percentage of participants whose modified Rankin Scale score increases by at least 1 point from baseline.
Time frame: Baseline to 6 months
Participants with an increase of at least 1 point in the modified Rankin Scale score at 12 months
Neurological disability will be assessed using the modified Rankin Scale, which ranges from 0 to 6, with higher scores indicating greater disability. The outcome will be reported as the percentage of participants whose modified Rankin Scale score increases by at least 1 point from baseline.
Time frame: Baseline to 12 months
Participants with an increase of at least 1 point in the modified Rankin Scale score at 24 months
Neurological disability will be assessed using the modified Rankin Scale, which ranges from 0 to 6, with higher scores indicating greater disability. The outcome will be reported as the percentage of participants whose modified Rankin Scale score increases by at least 1 point from baseline.
Time frame: Baseline to 24 months
All-cause mortality within 24 months
The outcome will be reported as the percentage of participants who die from any cause during follow-up.
Time frame: From enrollment through 24 months
Vascular mortality within 24 months
The outcome will be reported as the percentage of participants whose death is adjudicated as being due to a vascular cause during follow-up.
Time frame: From enrollment through 24 months
Change from baseline in Montreal Cognitive Assessment total score at 12 months
Cognitive function will be assessed using the Montreal Cognitive Assessment. The total score ranges from 0 to 30, with higher scores indicating better cognitive performance. Change will be calculated as the 12-month total score minus the baseline total score. A negative value indicates a decline in cognitive performance.
Time frame: Baseline to 12 months
Participants with a decrease of at least 1 point in Montreal Cognitive Assessment total score at 12 months
Cognitive function will be assessed using the Montreal Cognitive Assessment, which ranges from 0 to 30, with higher scores indicating better cognitive performance. Cognitive decline for this outcome is defined as a decrease of at least 1 point in the total score from baseline. The outcome will be reported as the percentage of participants meeting this criterion.
Time frame: Baseline to 12 months
Change from baseline in Montreal Cognitive Assessment total score at 24 months
Cognitive function will be assessed using the Montreal Cognitive Assessment. The total score ranges from 0 to 30, with higher scores indicating better cognitive performance. Change will be calculated as the 24-month total score minus the baseline total score. A negative value indicates a decline in cognitive performance.
Time frame: Baseline to 24 months
Participants with a decrease of at least 1 point in Montreal Cognitive Assessment total score at 24 months
Cognitive function will be assessed using the Montreal Cognitive Assessment, which ranges from 0 to 30, with higher scores indicating better cognitive performance. Cognitive decline for this outcome is defined as a decrease of at least 1 point in the total score from baseline. The outcome will be reported as the percentage of participants meeting this criterion.
Time frame: Baseline to 24 months
Disease progression at 12 months
Disease progression is defined as the presence of at least one prespecified imaging change compared with baseline, including progression of intracranial arterial stenosis or occlusion, reduction in collateral circulation, or deterioration in cerebral perfusion according to the study protocol. The outcome will be reported as the percentage of participants meeting the criteria for disease progression.
Time frame: Baseline to 12 months
Disease progression at 24 months
Disease progression is defined as the presence of at least one prespecified imaging change compared with baseline, including progression of intracranial arterial stenosis or occlusion, reduction in collateral circulation, or deterioration in cerebral perfusion according to the study protocol. The outcome will be reported as the percentage of participants meeting the criteria for disease progression.
Time frame: Baseline to 24 months
Conversion from initial conservative management to cerebral revascularization within 24 months
Among participants initially managed conservatively, the outcome is defined as subsequent cerebral revascularization performed during follow-up because surgery is considered clinically necessary. Treatment decisions are made by treating physicians and participants and are not assigned by the study protocol. The outcome will be reported as the percentage of initially conservatively managed participants undergoing cerebral revascularization.
Time frame: From enrollment through 24 months
Plan to share: No — Individual participant data will not be shared because of participant privacy, ethical requirements, and data security considerations.
No publications or documents are linked to this record.
Started Aug 2026 (actual). Primary completion is estimated for Feb 2030, 42 months after the start.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
Contact study teamGet an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.