Actively Recruiting

Age: 1Year - 80Years
All Genders
ID04572568

Registry of Multimodality Treatment for Brain Arteriovenous Malformation in Mainland China

Led by Beijing Tiantan Hospital · Updated on 2022-05-23

2000

Participants Needed

1

Research Sites

52 weeks

Total Duration

On this page

Sponsors

B

Beijing Tiantan Hospital

Lead Sponsor

B

Beijing Neurosurgical Institute

Collaborating Sponsor

AI-Summary

What this Trial Is About

Researchers are conducting a multi-center, prospective registry study to explore the long-term outcomes of brain arteriovenous malformations (AVMs) in mainland China. This observational study, supported by the National Key Research and Development Program, aims to find standardized diagnosis and treatment processes by comparing patients treated with and without a multidisciplinary team approach. The study involves patients aged 1 to 80 years who have confirmed AVM diagnoses using advanced imaging techniques such as digital subtraction angiography and MRI. Participants are divided into two groups: an experimental group receiving treatment planned by a multidisciplinary team and a control group treated without such a protocol. Treatments include craniotomy, embolization, and stereotactic radiosurgery based on detailed preoperative evaluations. The multidisciplinary team follows strict treatment criteria depending on whether AVMs are ruptured or unruptured, recommending surgery, embolization, radiosurgery, or conservative care accordingly. The control group includes patients treated before the multidisciplinary team was established or without comprehensive evaluation. Patients' data, including baseline characteristics, imaging, surgical information, and follow-up outcomes, are collected through an electronic data capture system. Neurofunctional assessments occur at baseline, 3 months, 12 months, and 3 years post-treatment, evaluating outcomes such as the modified Rankin Scale, AVM obliteration rates, hemorrhage occurrence, and complication rates. Researchers also monitor improvements in epilepsy, headache, and neurological function over time. Follow-ups are conducted via clinical visits and telephone interviews, with imaging reviewed by experienced radiologists.

CONDITIONS

Brief Title

Registry of Multimodality Treatment for Brain Arteriovenous Malformation in Mainland China

Who Can Participate

Age: 1Year - 80Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Diagnosis of brain arteriovenous malformation confirmed by digital subtraction angiography (DSA) and/or magnetic resonance imaging (MRI)
  • Complete clinical and imaging data available
  • Patient or legal representative has agreed to participate and signed informed consent
  • Age between 1 and 80 years
Not Eligible

You will not qualify if you...

  • Previous treatment for AVM by surgery, embolization, or stereotactic radiosurgery before study inclusion
  • Expected survival time less than 6 months
  • Diagnosis of spinal arteriovenous malformations
  • Missing critical baseline or imaging data

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person) for diagnostic imaging and clinical data collection

Monitoring

Duration - Up to 20 years

Participants who undergo routine care are observed. Clinical baseline data and imaging data are collected through an electronic data capture system to facilitate ongoing input at different locations and times.

Follow-up visits at 3 to 6 months after treatment and annually thereafter through clinical visits and telephone interviews

Trial Site Locations

Total: 1 location

1

Capital medical university affiliated Beijing Tiantan hospital

Beijing, Beijing Municipality, China, 101100

Actively Recruiting

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Research Team

C

Chen Yu, MD

C

Chen Xiaolin, MD

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

2

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Published Research Related To This Trial

A Machine Learning Model Predicts the Outcome of SRS for Residual Arteriovenous Malformations after Partial Embolization: A Real-World Clinical Obstacle.

Xiangyu Meng, Dezhi Gao, Hongwei He...

https://pubmed.ncbi.nlm.nih.gov/35276397

Factors Affecting Volume Reduction Velocity for Arteriovenous Malformations After Treatment With Dose-Stage Stereotactic Radiosurgery.

Xiangyu Meng, Dezhi Gao, Hengwei Jin...

https://pubmed.ncbi.nlm.nih.gov/34988014

Stereotactic Radiosurgery With vs. Without Prior Embolization for Brain Arteriovenous Malformations: A Propensity Score Matching Analysis.

Debin Yan, Yu Chen, Zhipeng Li...

https://pubmed.ncbi.nlm.nih.gov/34712200

Radiosurgery-Based AVM Scale Is Proposed for Combined Embolization and Gamma Knife Surgery for Brain Arteriovenous Malformations.

Xiangyu Meng, Hongwei He, Peng Liu...

https://pubmed.ncbi.nlm.nih.gov/33859610

Long-Term Outcomes of Elderly Brain Arteriovenous Malformations After Different Management Modalities: A Multicenter Retrospective Study.

Yu Chen, Debin Yan, Zhipeng Li...

https://pubmed.ncbi.nlm.nih.gov/33679374

Long-term outcomes and prognostic predictors of 111 pediatric hemorrhagic cerebral arteriovenous malformations after microsurgical resection: a single-center experience.

Zhenghai Deng, Yu Chen, Li Ma...

https://pubmed.ncbi.nlm.nih.gov/32078085

Single-Stage Combined Embolization and Resection for Spetzler-Martin Grade III/IV/V Arteriovenous Malformations: A Single-Center Experience and Literature Review.

Yu Chen, Ruinan Li, Li Ma...

https://pubmed.ncbi.nlm.nih.gov/33193013