5T MRI and Metabolomics-Based Hemorrhage Risk Prediction in Moyamoya Disease

NCT07781579 | Recruiting DMC

• 1 other identifier: BJ-2025-222
• Study Type: observational
• Target: 500
• Locations: 1 country
• Sites: 1

Brief Summary

Intracranial hemorrhage is a leading cause of death and disability in patients with moyamoya disease (MMD), yet clinically available tools for predicting long-term hemorrhage risk are lacking. Dilatation and rupture of fragile collateral vessels are considered the main cause of MMD-related hemorrhage; however, conventional 1.5T/3.0T MRI cannot adequately quantify collateral vessel morphology, blood flow, and vessel wall features. Metabolomic alterations have been implicated in MMD pathogenesis, including angiogenesis and collateral vessel formation. This prospective cohort study will consecutively enroll patients with MMD or moyamoya syndrome confirmed by digital subtraction angiography (DSA) at Beijing Hospital. All participants will undergo preoperative 5.0T brain MRI, including time-of-flight MR angiography (TOF-MRA), 4D MRA, high-resolution vessel wall imaging (HR-VWI), 3D arterial spin labeling (ASL), and conventional sequences (T1WI, DWI, T2WI, SWI). Preoperative blood and urine samples will be collected for metabolomic profiling, and superficial temporal artery (STA) specimens trimmed during direct bypass surgery will be retained for immunohistochemical cross-validation. Using deep learning (VT-UNet for collateral vessel segmentation and Swin Transformer for feature extraction) combined with machine learning methods, the investigators will develop and validate an integrated hemorrhage risk prediction model that combines 5T MRI features, hemodynamic parameters, metabolomic biomarkers, and clinical baseline data. Participants will be followed for 12 months; new-onset intracranial hemorrhage, analyzed per cerebral hemisphere, will be the endpoint event. The study aims to (1) establish a hemorrhage risk stratification system for early identification of high-risk patients to guide timely surgical revascularization, and (2) identify core metabolomic and imaging biomarkers of MMD-related hemorrhage.

Conditions

Moyamoya Disease; Intracranial Hemorrhages; Stroke

Keywords

Moyamoya disease; Hemorrhage risk prediction; 5T MRI; Metabolomics; Deep learning; Collateral vessels; Machine learning; Prediction model

Outcome Measures

Primary Outcomes (1)

• New-onset intracranial hemorrhage within 12 months

  Analyzed per cerebral hemisphere. Hemorrhage events are adjudicated based on the participant's symptoms and confirmed by head CT or MRI. The time and location of each event are recorded. Participants who undergo rev

  Time Frame: 12 months after enrollment

Secondary Outcomes (1)

• Discriminative performance of the hemorrhage risk prediction model

  At model validation (Year 2)

Study Arms (2)

Hemorrhagic-type MMD group

Patients whose initial clinical manifestation is intracranial hemorrhage. All participants receive preoperative 5.0T MRI, blood and urine collection for metabolomics, and routine clinical assessment, followed for 12 months for new-onset hemorrhage (per cerebral hemisphere).

Ischemic-type MMD group

Patients whose initial clinical manifestation is ischemic stroke, transient ischemic attack, or incidental asymptomatic findings. Assessments and follow-up are identical to the hemorrhagic-type group, with new-onset hemorrhage (per cerebral hemisphere) as the endpoint event.

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with moyamoya disease or moyamoya syndrome confirmed by digital subtraction angiography (DSA) at the Department of Neurosurgery, Beijing Hospital, who meet the eligibility criteria and provide written informed consent. Participants are classified into a hemorrhagic-type group and an ischemic-type group according to their initial clinical presentation.

You may qualify if:

• Moyamoya disease or moyamoya syndrome confirmed by digital subtraction angiography (DSA).
• Able to undergo a 5.0T magnetic resonance imaging (MRI) examination.

You may not qualify if:

• Claustrophobia or any other condition precluding completion of imaging acquisition.
• Previous revascularization surgery in both cerebral hemispheres.
• Any intracranial hemorrhage event within 1 month before enrollment.

Sponsors & Collaborators

• Beijing Hospital: lead

Study Sites (1)

Beijing Hospital

Beijing, Beijing Municipality, 100730, China

RECRUITING

MeSH Terms

Conditions

Moyamoya Disease; Intracranial Hemorrhages; Stroke

Condition Hierarchy (Ancestors)

Carotid Artery Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Cerebral Arterial Diseases; Intracranial Arterial Diseases; Arterial Occlusive Diseases; Vascular Diseases; Cardiovascular Diseases; Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Shaosen Zhang, MD

CONTACT

+86 18611284839; longyoubafang@hotmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 16, 2026
• First Posted: August 24, 2026
• Study Start: February 1, 2026
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2027
• Last Updated: August 24, 2026

Record last verified: 2026-08

Locations

CN (1)