NCT07781579 5T MRI and Metabolomics-Based Hemorrhage Risk Prediction in Moyamoya Disease
| NCT ID | NCT07781579 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Beijing Hospital |
| Condition | Moyamoya Disease |
| Study Type | OBSERVATIONAL |
| Enrollment | 500 participants |
| Start Date | 2026-02-01 |
| Primary Completion | 2027-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 500 participants in total. It began in 2026-02-01 with a primary completion date of 2027-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility Criteria
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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07781579 clinical trial?
This trial is open to participants of all sexes, studying Moyamoya Disease. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07781579 currently recruiting?
Yes, NCT07781579 is actively recruiting participants. Contact the research team at longyoubafang@hotmail.com for enrollment information.
Where is the NCT07781579 trial being conducted?
This trial is being conducted at Beijing, China.
Who is sponsoring the NCT07781579 clinical trial?
NCT07781579 is sponsored by Beijing Hospital. The trial plans to enroll 500 participants.