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

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
AgeNot listed
SponsorBeijing Hospital

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Moyamoya disease or moyamoya syndrome confirmed by digital subtraction angiography (DSA).

Able to undergo a 5.0T magnetic resonance imaging (MRI) examination.

Disqualifiers

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.

Trial 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.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

Not listed

Trial groups

500 Participants
are grouped into 2 trial groups
Group A: Hemorrhagic-type MMD group
Group B: Ischemic-type MMD group

Trial outcomes

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
Time Frame: 12 months after enrollment

Secondary outcomes

1

Discriminative performance of the hemorrhage risk prediction model

Area under the receiver operating characteristic curve (AUROC) of the integrated 5T MRI and metabolomics-based hemorrhage risk prediction model in the validation cohort, with 5×5-fold cross-validation for internal validation.

Time frame
At model validation (Year 2)

Other outcomes

Sponsors and contacts

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