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Clinical Trials in China / NCT07781579
Recruiting Observational

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

NCT07781579 · tracked via the Priya Life Science China tracker
Sponsor
Beijing Hospital
Phase
Observational
Started
2026-02-01
Last updated
2026-08-24

Condition(s) studied

Moyamoya DiseaseIntracranial HemorrhagesStroke

Study 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.

Eligibility

Sex
ALL
Min age
Max age
Healthy volunteers
Accepted
Inclusion Criteria: * Moyamoya disease or moyamoya syndrome confirmed by digital subtraction angiography (DSA). * Able to undergo a 5.0T magnetic resonance imaging (MRI) examination. Exclusion Criteria: * 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.

Primary outcome measure(s)

Trial sites (1)

FacilityCityRegionStatus
Beijing Hospital Beijing Beijing Municipality Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07781579 on ClinicalTrials.gov ↗ ← All trials in China