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

StatusRecruiting
PhaseNot specified
Started
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Record History

  1. Minor Study First Submitted
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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.
Trial Details
NCT Number NCT07781579
Lead Sponsor Beijing Hospital
Conditions
(from sponsor)
Moyamoya Disease, Intracranial Hemorrhages, Stroke
Related terms Intracranial Hemorrhages, Moyamoya Disease, Stroke
Enrollment 500 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov