Fact CheckerSign in

NCT07781579Recruiting

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

Development and Validation of a Hemorrhage Risk Prediction Model for Moyamoya Disease Based on 5T MRI and Metabolomic Features: A Prospective Cohort Study

Source: ClinicalTrials.gov · Last updated 24 Aug 2026

Brief summary (registry, in English)

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.

Status (registry)
Recruiting
Study type
Observational
Enrollment
500 (estimated)
First submitted
16 Aug 2026
Start date
1 Feb 2026
Primary completion date
31 Dec 2027
Lead sponsor
Beijing Hospital
Diseases
Stroke
NCT number
NCT07781579

What you commit to

  • Study type: Observational
  • Planned participants: 500
  • From 1 Feb 2026 to the primary completion date, 31 Dec 2027
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Previous revascularization surgery in both cerebral hemispheres.
  • Any intracranial hemorrhage event within 1 month before enrollment.

Other illness

  • Claustrophobia or any other condition precluding completion of imaging acquisition.

Who the study is looking for

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

Sex: All · Accepts healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Beijing Hospital
Coordinator of this site? Confirm its status
BeijingChinaRecruiting

This page is information, not medical advice. Discuss any trial with your doctor.