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

Brain Arteriovenous Malformations Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05449106
• Other study ID #: KY2022-054-02
• Status: Recruiting
• Start date: May 25, 2022
• Est. completion date: May 25, 2032

Study information

• Verified date: August 2023
• Source: Beijing Tiantan Hospital
• Contact: Shaosen Zhang, Doctor
• Phone: +8618611284839
• Email: longyoubafang[@]hotmail.com
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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).

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 information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: May 25, 2032
• Est. primary completion date: May 25, 2027
• Accepts healthy volunteers: No
• Gender: All
• Age group: 3 Years to 80 Years

Eligibility

Inclusion Criteria:

1. Patients with confirmed diagnosis of brain arteriovenous malformations in the brain, basal ganglia, thalamus, corpus callosum, cerebellum and other locations.

2. Patients with no history of previous arteriovenous malformation-related hemorrhage and no arteriovenous malformation-related hemorrhage confirmed by CT examination.

3. Patients with Radiographic examinations completed without any treatment

Exclusion Criteria:

1. Patients with simple arteriovenous fistula.

2. Patients with combined dural arteriovenous fistulas.

3. Arteriovenous malformations occurring in the spinal cord.

4. Pregnant patients were not included in this study.

Related Conditions & MeSH terms

• Arteriovenous Malformations
• Brain Arteriovenous Malformations
• Congenital Abnormalities
• Hemangioma

Locations

Country	Name	City	State
China	Beijing Hospital	Beijing	Beijing
China	Beijing Tiantan Hospital, Capital Medical University	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

Sponsors (4)

Lead Sponsor	Collaborator
Beijing Tiantan Hospital	Beijing Hospital, The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School, The First Affiliated Hospital of Zhengzhou University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of participants with rupture events	Arteriovenous malformation rupture during follow-up before treatment	3 years after enrollment
Primary	Number of participants with epilepsy Progression	Progression of seizure symptoms during follow-up, including but not limited to more frequent seizures, worsening of symptoms, etc.	3 years after enrollment
Primary	Number of participants with new onset neurological dysfunction	New neurological deficits during the follow-up period, including motor deficits, cognitive deficits, etc.	3 years after enrollment
Secondary	Number of participants receiving treatment	Patients receiving any form of intervention during the follow-up period will stop the follow-up	3 years after enrollment