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

Condition(s) studied

Study summary

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).

Eligibility

Primary outcome measure(s)

• Number of participants with rupture events — 3 years after enrollment
  Arteriovenous malformation rupture during follow-up before treatment
• Number of participants with epilepsy Progression — 3 years after enrollment
  Progression of seizure symptoms during follow-up, including but not limited to more frequent seizures, worsening of symptoms, etc.
• Number of participants with new onset neurological dysfunction — 3 years after enrollment
  New neurological deficits during the follow-up period, including motor deficits, cognitive deficits, etc.

Trial sites (4)

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