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

Sponsor

Beijing Tiantan Hospital (Other)

Overall Status

Recruiting

CT.gov ID

NCT05449106

Collaborator

Beijing Hospital (Other), The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School (Other), The First Affiliated Hospital of Zhengzhou University (Other)

200

Enrollment

Locations

120

Anticipated Duration (Months)

Patients Per Site

0.4

Patients Per Site Per Month

Study Details

Study Description

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:

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).

Condition or Disease	Intervention/Treatment	Phase
Brain Arteriovenous Malformations

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:

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:

Baseline information
CT images: including non-contrast CT(NCCT), CT Angiography, CT perfusion
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)
Digital subtraction angiography(DSA, optional)
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, ensuring by CT scan;
New epilepsy symptoms or exacerbations, ensuring by consultation or EEG ;
New neurological dysfunction(including motor dysfunction, cognitive dysfunction, etc), ensuring by consultation, physical examination or any radiology examination.

Inclusion criteria

Patients with confirmed diagnosis of bAVMs in the cerebrum, basal ganglia, thalamus, corpus callosum, cerebellum and brainstem;
Patients with no history of previous bAVM related hemorrhage confirmed by CT examination, or have radiographic examination completed prior to the hemorrhage.
Patients with radiographic examinations before any treatment;

Exclusion criteria.

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

Study Design

Study Type:

Observational [Patient Registry]

Anticipated Enrollment :

200 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

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

Actual Study Start Date :

May 25, 2022

Anticipated Primary Completion Date :

May 25, 2027

Anticipated Study Completion Date :

May 25, 2032

Outcome Measures

Primary Outcome Measures

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.

Secondary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

3 Years to 80 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

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

Exclusion Criteria:

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Beijing Tiantan Hospital, Capital Medical University	Beijing	Beijing	China	100070
2	Beijing Hospital	Beijing	Beijing	China	102249
3	The First Affiliated Hospital of Zhengzhou University	Zhengzhou	Henan	China	450052
4	The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School	Nanjing	Jiangsu	China	210008

Sponsors and Collaborators

Beijing Tiantan Hospital
Beijing Hospital
The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
The First Affiliated Hospital of Zhengzhou University

Investigators

Study Chair: Dong Zhang, Doctor, Beijing Tiantan Hospital, Beijing Hospital
Study Director: Shaosen Zhang, Doctor, Beijing Tiantan Hospital
Principal Investigator: Guosheng Zhou, The First Affiliated Hospital of Zhengzhou University
Principal Investigator: Yongbo Yang, The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School