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
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 200
- 试验地点
- 4
- 主要终点
- Number of participants with epilepsy Progression
研究概览
简要总结
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:
- Morphological, structural and imaging histological signal analysis based on multimodal CT to explore the relationship between imaging features and different clinical outcomes of bAVMs.
- 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.
- 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:
- Hemorrhage events associated with bAVMs
- New epilepsy symptoms or exacerbations
- New neurological dysfunction(including motor dysfunction, cognitive dysfunction, etc).
详细描述
This study is a Long-term, multi-center, prospective registry study, and was supported by China National Key Research and Development Program Project No. 2021YFC2500502.
The purpose of this study is to investigate the role of multimodal Computer Tomography(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:
- Morphological, structural and imaging histological signal analysis based on multimodal CT to study the relationship between imaging features and different clinical outcomes of bAVMs.
- 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.
- Based on multimodal CT and deep learning algorithms to create an automated segmentation model for bAVMs and a prediction model for distinct clinical outcomes.
- To compare the efficacy of multimodal CT and MRI in evaluating the clinical outcomes of unruptured cerebral arteriovenous malformations.
The obtained patient information includes:
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 3 Years 至 80 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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.
结局指标
主要结局
Number of participants with epilepsy Progression
时间窗: 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
时间窗: 3 years after enrollment
New neurological deficits during the follow-up period, including motor deficits, cognitive deficits, etc.
Number of participants with rupture events
时间窗: 3 years after enrollment
Arteriovenous malformation rupture during follow-up before treatment
次要结局
- Number of participants receiving treatment(3 years after enrollment)