Evaluation of Clinical Outcomes of Unruptured Brain Arteriovenous Malformations Treated With Medical Management Alone Based on Multimodal Computer Tomography: A Long-term Multicenter Prospective Cohort Study

What this Trial Is About

Researchers are studying the role of multimodal Computer Tomography (CT) in assessing and predicting various clinical outcomes in patients with unruptured brain arteriovenous malformations (bAVMs) who are treated with medical management alone. This long-term, multi-center, prospective registry study aims to explore how imaging features and blood flow patterns relate to clinical outcomes, using advanced analysis and deep learning algorithms to develop automated models for segmentation and prediction. The study also compares the effectiveness of multimodal CT and MRI in evaluating these outcomes. The study collects detailed patient information including baseline data, multiple CT image types (non-contrast CT, CT Angiography, CT perfusion), various MRI sequences (T1, T2, T2-FLAIR, TOF-MRA, DWI, SWI), and optionally digital subtraction angiography (DSA). Patients are monitored over time with follow-up visits scheduled at 6, 12, 24, and 36 months after enrollment. These visits are used to observe hemorrhage events, new or worsening epilepsy symptoms, and new neurological dysfunctions such as motor or cognitive impairments. Participants undergo consultations, physical examinations, radiology tests, and EEGs as needed during follow-up to track these outcomes. The primary outcomes measured include the number of hemorrhage events, epilepsy progressions, and new neurological dysfunction cases occurring within three years after enrollment. Secondary outcomes include the number of participants receiving any treatment during this period. The study is sponsored by Beijing Tiantan Hospital and involves patients aged 3 to 80 years old with confirmed unruptured bAVMs.

Evaluation of Clinical Outcomes of Unruptured bAVMs Treated With Medical Management Alone Based on Multimodal CT