Risk prediction for stroke and cognitive decline in Moyamoya disease and Moyamoya syndrome

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This multicenter, prospective observational study plans to enroll about 3,000 patients with Moyamoya disease or Moyamoya syndrome and follow them for up to 24 months. Researchers will collect demographic, clinical, cognitive, laboratory, and multimodal imaging data at baseline, including vascular imaging and various MRI sequences when available. They will develop and validate prediction models for ischemic stroke, intracerebral hemorrhage, and cognitive decline using multidimensional data, with patients receiving standard care and treatment decisions made by their physicians and patients. Primary outcome is incident stroke within 24 months, with secondary outcomes including earlier strokes, TIA, functional change, mortality, and cognitive change measured by the Montreal Cognitive Assessment.

Why it matters

Who can join: the full rules

Inclusion Criteria

1. Age 12 to 70 years.
2. Diagnosis of moyamoya disease or moyamoya syndrome by DSA, CTA or MRA.
3. Ability to complete neurological and cognitive assessments.
4. Ability to complete at least 12 months of clinical follow-up and willingness, in principle, to complete 24 months of follow-up.
5. At least one analyzable baseline vascular imaging examination in original DICOM format, including CTA, MRA, or DSA.
6. Written informed consent provided by the participant and/or legally authorized representative.

Exclusion Criteria

1. Refusal to participate or inability to complete follow-up.
2. Pregnancy or breastfeeding.
3. Coexisting cerebrovascular malformation, intracranial tumor, hydrocephalus, or another disorder that may independently affect stroke or cognitive outcomes.
4. 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.
5. 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.
6. 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.
7. Previous cerebral revascularization surgery.

Where it's running

• Beijing Tiantan Hospital
  Beijing, Beijing Municipality, China Recruiting
• Xuanwu Hospital, Capital Medical University
  Beijing, Beijing Municipality, China Not yet recruiting
• Peking Union Medical College Hospital
  Beijing, Beijing Municipality, China Not yet recruiting
• The First Medical Center, Chinese PLA General Hospital
  Beijing, Beijing Municipality, China Not yet recruiting
• Henan Provincial People's Hospital
  Zhengzhou, Henan, China Not yet recruiting
• The First Affiliated Hospital of Zhengzhou University
  Zhengzhou, Henan, China Not yet recruiting

Study contacts

• Study coordinator: Qian Zhang
• Email: zhangqianttchina@163.com
• Phone: 010-59978316

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Ischemic preconditioning to reduce ischemic events in Moyamoya with standard care

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• 5T MRI and Metabolomics to Predict Hemorrhage Risk in Moyamoya Disease

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• XR-assisted CT-guided localization for EC-IC bypass in Moyamoya and chronic cerebral ischemia

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• Family screening and early detection for moyamoya disease

  This project will try to find biological signs and 5T high-resolution MRI features that could detect moyamoya earlier in people with the disease, their first-degree relatives, and people without a family history.

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• Remimazolam: target-controlled infusion versus manual infusion during cerebrovascular bypass

  This trial will test whether target-controlled infusion uses less remimazolam than manual infusion in adults undergoing cerebrovascular bypass surgery for moyamoya disease.

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• Cardiac index–guided blood flow management during pediatric Moyamoya EDAS surgery

  This study will test whether using each child's cardiac index to guide fluids and hemodynamic care during EDAS lowers postoperative transient ischemic episodes in children with Moyamoya disease.

  Recruiting Seoul National University Hospital · Seoul · NCT07304947

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.