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

Recruiting now

Conditions studied: Brain Arteriovenous Malformations

In brief

The purpose of this study is to investigate the role of multimodal CT in evaluating and predicting different clinical outcomes in patients with unruptured brain arteriovenous malformations with medical management alone. This study will be undertaken in the following aspects: 1. Morphological, structural and imaging histological signal analysis based on multimodal CT to explore the relationship between imaging features and different clinical outcomes of bAVMs. 2. Hemodynamic and flow pattern analysis of local and peripheral bAVMs based on multimodal CT to explore the association between blood flow features and different clinical outcomes. 3. Based on multimodal CT and deep learning algorithms to create an automated segmentation model for bAVMs and a prediction model for distinct clinical outcomes. The obtained patient information includes: Baseline information, CT, MRI, DSA (Optional), and follow-up information. Follow-up will be undertaken at 6 months, 12 months, 24 months and 36 months after enrollment with the following primary observation. Main observation endpoints: 1. Hemorrhage events associated with bAVMs 2. New epilepsy symptoms or exacerbations 3. New neurological dysfunction(including motor dysfunction, cognitive dysfunction, etc).

Key facts

Study ID

NCT05449106

Run by

Beijing Tiantan Hospital

People needed

200

Starts

2022-05-25

Expected to finish

2032-05-25

Last updated by the study team

2023-09-07

Who can join

Age: 3 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Patients with confirmed diagnosis of brain arteriovenous malformations in the brain, basal ganglia, thalamus, corpus callosum, cerebellum and other locations.
• Patients with no history of previous arteriovenous malformation-related hemorrhage and no arteriovenous malformation-related hemorrhage confirmed by CT examination.
• Patients with Radiographic examinations completed without any treatment

You may not qualify if…

• Patients with simple arteriovenous fistula.
• Patients with combined dural arteriovenous fistulas.
• Arteriovenous malformations occurring in the spinal cord.
• Pregnant patients were not included in this study.

Where it is running

• Beijing Tiantan Hospital, Capital Medical University — Beijing, Beijing Municipality, China (enrolling)
• Beijing Hospital — Beijing, Beijing Municipality, China (enrolling)
• The First Affiliated Hospital of Zhengzhou University — Zhengzhou, Henan, China (enrolling)
• The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School — Nanjing, Jiangsu, China (enrolling)

Full record on ClinicalTrials.gov

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