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

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).

Study Overview

• Status: Recruiting
• Conditions: 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:

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.

• Study Type: Observational
• Enrollment (Estimated): 200

Contacts and Locations

• Study Contact: Name: Shaosen Zhang, Doctor; Phone Number: +8618611284839; Email: longyoubafang@hotmail.com

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China, 100070
      • Recruiting
      • Beijing Tiantan Hospital, Capital Medical University
      • Contact: Shaosen Zhang, Doctor; Phone Number: +8618611284839; Email: longyoubafang@hotmail.com
      • Principal Investigator: Dong Zhang, Doctor
      • Principal Investigator: Xinjian Yang, Doctor
      • Principal Investigator: Shaosen Zhang, Doctor
      • Principal Investigator: Lebao Yu, Doctor
      • Principal Investigator: Yuanren Zhai, Doctor
      • Principal Investigator: Liangran Huang, Doctor
      • Principal Investigator: Wei Liu, Master
    • Beijing, Beijing, China, 102249
      • Recruiting
      • Beijing Hospital
      • Contact: Jun Lu, Doctor; Phone Number: 13521208691; Email: lujun3655@bjhmoh.cn
      • Principal Investigator: Jun Lu, Doctor
  • Henan
    • Zhengzhou, Henan, China, 450052
      • Recruiting
      • The First Affiliated Hospital of Zhengzhou University
      • Contact: Yingwei Zhen, Doctor; Phone Number: +8618739929265; Email: zhenyw@aliyun.com
      • Principal Investigator: Guosheng Zhou, Doctor
      • Principal Investigator: Yingwei Zhen, Doctor
  • Jiangsu
    • Nanjing, Jiangsu, China, 210008
      • Recruiting
      • The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
      • Contact: Zhiyong Shi, Doctor; Phone Number: +861501104692; Email: szy1195156829@aliyun.com
      • Principal Investigator: Yongbo Yang, Doctor
      • Principal Investigator: Zhiyong Shi, Doctor

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 3 years to 80 years (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Patients with the diagnosis of AVM was confirmed with Digital Subtraction Angiography (DSA) , Magnetic Resonance Imaging(MRI), or Computed Tomography Angiography, eligible for enrollment criteria and have images that were acquired without any intervention.

Description

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.

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of participants with rupture events	Arteriovenous malformation rupture during follow-up before treatment	3 years after enrollment
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
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Beijing Tiantan Hospital
• Collaborators: The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School; Beijing Hospital; 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

Study record dates

Study Major Dates

• Study Start (Actual): May 25, 2022
• Primary Completion (Estimated): May 25, 2027
• Study Completion (Estimated): May 25, 2032

Study Registration Dates

• First Submitted: July 4, 2022
• First Submitted That Met QC Criteria: July 4, 2022
• First Posted (Actual): July 8, 2022

Study Record Updates

• Last Update Posted (Actual): September 7, 2023
• Last Update Submitted That Met QC Criteria: September 5, 2023
• Last Verified: August 1, 2023

More Information

Terms related to this study

• Keywords: Machine learning; Unruptured arteriovenous malformations; Multimodal CT
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Neoplasms by Histologic Type; Neoplasms; Cardiovascular Abnormalities; Neoplasms, Vascular Tissue; Vascular Malformations; Congenital Abnormalities; Hemangioma; Arteriovenous Malformations
• Other Study ID Numbers: KY2022-054-02

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No