Evaluation of Clinical Outcomes of Unruptured bAVMs Treated With Medical Management Alone Based on Multimodal CT
- Conditions
- Brain Arteriovenous Malformations
- Registration Number
- NCT05449106
- Lead Sponsor
- Beijing Tiantan Hospital
- Brief 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).
- Detailed Description
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:
1. Morphological, structural and imaging histological signal analysis based on multimodal CT to study 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.
4. To compare the efficacy of multimodal CT and MRI in evaluating the clinical outcomes of unruptured cerebral arteriovenous malformations.
The obtained patient information includes:
1. Baseline information
2. CT images: including non-contrast CT(NCCT), CT Angiography, CT perfusion
3. Magnetic Resonance Imaging(MRI): including T1-weighted image, T2-weighted image, T2-FLAIR, Time of Flight MR angiography(TOF-MRA), diffusion-weighted imaging(DWI), susceptibility weighted imaging(SWI)
4. Digital subtraction angiography(DSA, optional)
5. 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, ensuring by CT scan;
2. New epilepsy symptoms or exacerbations, ensuring by consultation or EEG ;
3. New neurological dysfunction(including motor dysfunction, cognitive dysfunction, etc), ensuring by consultation, physical examination or any radiology examination.
Inclusion criteria
1. Patients with confirmed diagnosis of bAVMs in the cerebrum, basal ganglia, thalamus, corpus callosum, cerebellum and brainstem;
2. Patients with no history of previous bAVM related hemorrhage confirmed by CT examination, or have radiographic examination completed prior to the hemorrhage.
3. Patients with radiographic examinations before any treatment;
Exclusion criteria.
1. Patients with simple arteriovenous fistula;
2. Patients with combined dural arteriovenous fistula;
3. Arteriovenous malformations occurring in the spinal cord;
4. Pregnant patients were not included in this study.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 200
- 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
- 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.
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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.
Number of participants with rupture events 3 years after enrollment Arteriovenous malformation rupture during follow-up before treatment
- Secondary Outcome Measures
Name Time Method Number of participants receiving treatment 3 years after enrollment Patients receiving any form of intervention during the follow-up period will stop the follow-up
Trial Locations
- Locations (4)
Beijing Tiantan Hospital, Capital Medical University
🇨🇳Beijing, Beijing, China
Beijing Hospital
🇨🇳Beijing, Beijing, China
The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
🇨🇳Nanjing, Jiangsu, China
The First Affiliated Hospital of Zhengzhou University
🇨🇳Zhengzhou, Henan, China