Moyamoya DiseaseNCT07894107
Development and Validation of Risk Prediction Models for Stroke and Cognitive Impairment in Moyamoya Disease and Moyamoya Syndrome
An observational study of Moyamoya Disease and Moyamoya Syndrome, run by Beijing Tiantan Hospital at 13 sites in China.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 12 to 70 years
- Conditions the study is for
- Moyamoya Disease, Moyamoya Syndrome
- How many people
- 3,000 participants
- Where
- 13 sitesChina
- Study dates
- 3 Aug 2026to 28 Feb 2030
- Phase
- Observational
- 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 12 to 70 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients with moyamoya disease or moyamoya syndrome diagnosed by imaging criteria at participating centers.
Who may be able to join
- Age 12 to 70 years.
- Diagnosis of moyamoya disease or moyamoya syndrome by DSA, CTA or MRA.
- Ability to complete neurological and cognitive assessments.
- Ability to complete at least 12 months of clinical follow-up and willingness, in principle, to complete 24 months of follow-up.
- At least one analyzable baseline vascular imaging examination in original DICOM format, including CTA, MRA, or DSA.
- Written informed consent provided by the participant and/or legally authorized representative.
Who cannot join
- Refusal to participate or inability to complete follow-up.
- Pregnancy or breastfeeding.
- Coexisting cerebrovascular malformation, intracranial tumor, hydrocephalus, or another disorder that may independently affect stroke or cognitive outcomes.
- Severe visual impairment, aphasia, impaired consciousness, psychiatric illness, or another disorder that prevents valid cognitive assessment, including Alzheimer's disease, Parkinson's disease, or frontotemporal dementia.
- Cardiac conditions that may cause cardioembolic stroke, including atrial fibrillation, patent foramen ovale or other right-to-left shunting cardiac disease, intracardiac mural thrombus, or infective endocarditis; or severe hepatic or renal dysfunction, coagulation disorders, malignancy, or severe cardiopulmonary disease.
- Receipt of an investigational drug or device within 30 days before screening, or current participation in another interventional clinical trial that may interfere with this study.
- Previous cerebral revascularization surgery.
Trial locations and contacts
13 sites in 1 country. Contact the study team or a site near you to ask about taking part.
13 sites in 1 country
China13 sites, 13 recruiting
- Not yet recruiting
Xuanwu Hospital, Capital Medical University
Beijing, Beijing Municipality, 100053
Jiewen Geng, 010-64422028, jiewenxiaodaifu@163.com
- Recruiting
Beijing Tiantan Hospital
Beijing, Beijing Municipality, 100070
Qian Zhang, 010-59978316, zhangqianttchina@163.com
- Not yet recruiting
Peking Union Medical College Hospital
Beijing, Beijing Municipality, 100730
Xiao Zhang, 010-69152530, zhangxiao@pumch.cn
- Not yet recruiting
The First Medical Center, Chinese PLA General Hospital
Beijing, Beijing Municipality, 100853
Cong Han, +8613466346163, hc82225@126.com
- Not yet recruiting
West China Hospital, Sichuan University
Chengdu, Sichuan, 610041
Minghong Yao, +8618215609398, mh_0705@wchscu.cn
- Not yet recruiting
The Second Affiliated Hospital, Zhejiang University School of Medicine
Hangzhou, Zhejiang, 310009
Lin Wang, 0571-87784783, wanglin_77@hotmail.com
- Not yet recruiting
The First Affiliated Hospital of Nanchang University
Nanchang, Jiangxi, 330006
Erming Zeng, 0791-88692532, ermingzeng@aliyun.com
- Not yet recruiting
Huashan Hospital, Fudan University
Shanghai, Shanghai Municipality, 200040
Wei Ni, 021-52889999, hsniwei@fudan.edu.cn
- Not yet recruiting
Children's Hospital of Fudan University
Shanghai, Shanghai Municipality, 201102
Hao Li, 021-64931990, lihao7272@163.com
- Not yet recruiting
The First Affiliated Hospital of Soochow University
Suzhou, Jiangsu, 215006
Yabo Huang, 0512-67780162, sdfyyhyb@126.com
- Not yet recruiting
Zhongnan Hospital of Wuhan University
Wuhan, Hubei, 430071
Jianjian Zhang, 027-67813118, zj57470@126.com
- Not yet recruiting
Henan Provincial People's Hospital
Zhengzhou, Henan, 450003
Liming Zhao, 0371-66580255, zhaoliming1201@126.com
- Not yet recruiting
The First Affiliated Hospital of Zhengzhou University
Zhengzhou, Henan, 451191
Hongwei Li, +8615713817798, hongwei706@126.com
About this study
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.
Read the detailed description
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.
- Conditions
- Moyamoya Disease, Moyamoya Syndrome
- Keywords
- Stroke, Multimodal neuroimaging, Artificial intelligence, Cognitive impairment, Ischemic stroke, Intracerebral hemorrhage, Risk prediction, RNF213
- Medical subject headings
- Moyamoya Disease, Stroke, Cognitive Dysfunction, Ischemic Stroke, Cerebral Hemorrhage, Moyamoya disease 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Patients with moyamoya disease or moyamoya syndrome | 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: From enrollment through 24 months
Secondary outcomes (17)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: From enrollment through 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Oct 2026
- Study start3 Aug 2026
- Primary completion28 Feb 2030 (estimated)
- Study completion28 Feb 2030 (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.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 3,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Beijing Tiantan Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- West China Hospital, The First Affiliated Hospital of Soochow University, The First Medical Center of Chinese PLA General Hospital, Huashan Hospital, Zhongnan Hospital, Peking Union Medical College Hospital, Xuanwu Hospital, Beijing, Henan Provincial People's Hospital, The First Affiliated Hospital of Zhengzhou University, The First Affiliated Hospital of Nanchang University, Children's Hospital of Fudan University, Second Affiliated Hospital, Zhejiang University, School of Medicine
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07894107
- Sponsor's protocol ID
- KY2026-115-02
- Other IDs
- 2026ZD0554903
- Status last verified
- Oct 2026
- First submitted
- 27 Aug 2026
- Last updated
- 26 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be shared because of participant privacy, ethical requirements, and data security considerations.
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development and Validation of Risk Prediction Models for Stroke and Cognitive Impairment in Moyamoya Disease and Moyamoya Syndrome
- ClinicalTrials.gov ID
- NCT07894107
- Acronym / sponsor ID
- KY2026-115-02
- Conditions
- Moyamoya Disease, Moyamoya Syndrome
- Keywords
- Stroke, Multimodal neuroimaging, Artificial intelligence, Cognitive impairment, Ischemic stroke, Intracerebral hemorrhage, Risk prediction, RNF213
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 3,000 participants (estimated)
- Lead sponsor
- Beijing Tiantan HospitalUniversity, hospital or other
- Collaborators
- West China Hospital, The First Affiliated Hospital of Soochow University, The First Medical Center of Chinese PLA General Hospital, Huashan Hospital, Zhongnan Hospital, Peking Union Medical College Hospital, Xuanwu Hospital, Beijing, Henan Provincial People's Hospital, The First Affiliated Hospital of Zhengzhou University, The First Affiliated Hospital of Nanchang University, Children's Hospital of Fudan University, Second Affiliated Hospital, Zhejiang University, School of Medicine
- Study start
- 3 Aug 2026 (actual)
- Primary completion
- 28 Feb 2030 (estimated)
- Study completion
- 28 Feb 2030 (estimated)
- First posted
- 26 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 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.
Detailed description
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with moyamoya disease or moyamoya syndrome | – | –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. |
Who may qualify
- Ages
- 12 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients with moyamoya disease or moyamoya syndrome diagnosed by imaging criteria at participating centers.
Key inclusion criteria (6 listed)
- Age 12 to 70 years.
- Diagnosis of moyamoya disease or moyamoya syndrome by DSA, CTA or MRA.
- Ability to complete neurological and cognitive assessments.
- Ability to complete at least 12 months of clinical follow-up and willingness, in principle, to complete 24 months of follow-up.
- At least one analyzable baseline vascular imaging examination in original DICOM format, including CTA, MRA, or DSA.
Key exclusion criteria (7 listed)
- Refusal to participate or inability to complete follow-up.
- Pregnancy or breastfeeding.
- Coexisting cerebrovascular malformation, intracranial tumor, hydrocephalus, or another disorder that may independently affect stroke or cognitive outcomes.
- Severe visual impairment, aphasia, impaired consciousness, psychiatric illness, or another disorder that prevents valid cognitive assessment, including Alzheimer's disease, Parkinson's disease, or frontotemporal dementia.
- Cardiac conditions that may cause cardioembolic stroke, including atrial fibrillation, patent foramen ovale or other right-to-left shunting cardiac disease, intracardiac mural thrombus, or infective endocarditis; or severe hepatic or renal dysfunction, coagulation disorders, malignancy, or severe cardiopulmonary disease.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Incidence of stroke within 24 months after enrollment
Time frame: From enrollment through 24 months
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.
17 secondary outcomes
Incidence of stroke within 6 months after enrollment
Time frame: From enrollment through 6 months
Incidence of stroke within 12 months after enrollment
Time frame: From enrollment through 12 months
Incidence of transient ischemic attack within 24 months
Time frame: From enrollment through 24 months
Number of transient ischemic attack episodes within 24 months
Time frame: From enrollment through 24 months
Incidence of disabling stroke within 24 months
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
Time frame: Baseline to 6 months
Participants with an increase of at least 1 point in the modified Rankin Scale score at 12 months
Time frame: Baseline to 12 months
Participants with an increase of at least 1 point in the modified Rankin Scale score at 24 months
Time frame: Baseline to 24 months
All-cause mortality within 24 months
Time frame: From enrollment through 24 months
Vascular mortality within 24 months
Time frame: From enrollment through 24 months
Change from baseline in Montreal Cognitive Assessment total score at 12 months
Time frame: Baseline to 12 months
Participants with a decrease of at least 1 point in Montreal Cognitive Assessment total score at 12 months
Time frame: Baseline to 12 months
Change from baseline in Montreal Cognitive Assessment total score at 24 months
Time frame: Baseline to 24 months
Participants with a decrease of at least 1 point in Montreal Cognitive Assessment total score at 24 months
Time frame: Baseline to 24 months
Disease progression at 12 months
Time frame: Baseline to 12 months
Disease progression at 24 months
Time frame: Baseline to 24 months
Conversion from initial conservative management to cerebral revascularization within 24 months
Time frame: From enrollment through 24 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 26 Oct 2026.
- Individual participant dataSharing planned: No. Individual participant data will not be shared because of participant privacy, ethical requirements, and data security considerations.
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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.
13 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Moyamoya Disease and Moyamoya Syndrome, run by Beijing Tiantan Hospital at 13 sites 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 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: looking for participants now, as of the sponsor's last update on 26 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 13 sites 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?
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 Qian Zhang (010-59978316, zhangqianttchina@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of stroke within 24 months after enrollment (time frame: From enrollment through 24 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 26 Oct 2026.