Heart and Blood Diseases

Diseases and Abnormalities at or Before Birth

All Conditions

Neoplasms

Arteriovenous Malformations

Congenital Abnormalities

Hemangioma

Vascular Malformations

Cardiovascular Abnormalities

Vascular Diseases

Neoplasms, Vascular Tissue

Neoplasms by Histologic Type

Shaosen Zhang, Doctor

Dong Zhang, Doctor

Xinjian Yang, Doctor

Lebao Yu, Doctor

Yuanren Zhai, Doctor

Liangran Huang, Doctor

Wei Liu, Master

Jun Lu, Doctor

Yingwei Zhen, Doctor

Guosheng Zhou, Doctor

Zhiyong Shi, Doctor

Yongbo Yang, Doctor

Guosheng Zhou

Yongbo Yang

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).

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.

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

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

Arteriovenous malformation rupture during follow-up before treatment

Progression of seizure symptoms during follow-up, including but not limited to more frequent seizures, worsening of symptoms, etc.

New neurological deficits during the follow-up period, including motor deficits, cognitive deficits, etc.

Patients receiving any form of intervention during the follow-up period will stop the follow-up

Beijing Hospital

The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School

The First Affiliated Hospital of Zhengzhou University

Beijing Tiantan Hospital

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Evaluation of Clinical Outcomes of Unruptured bAVMs Treated With Medical Management Alone Based on Multimodal CT	NCT05449106	Brain Arteriove...		3 Years - 80 Years	Beijing Tiantan Hospital
Evaluation of Clinical Outcomes of Unruptured bAVMs Treated With Medical Management Alone Based on Multimodal CT	NCT05449106	Brain Arteriove...		3 Years - 80 Years	Beijing Tiantan Hospital

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