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RecruitingNCT05449106Updated Sep 7, 2023

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

An observational study in Brain Arteriovenous Malformations, sponsored by Beijing Tiantan Hospital. Recruiting at 4 sites in China. Open to participants aged 3 Years to 80 Years. Per ClinicalTrials.gov, last updated 2023-09-07.

Sponsored by Beijing Tiantan Hospital · Observational

From the registry’s dates

  • Started May 2022; still recruiting 4 years 4 months later.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
200
Ages
3 Years to 80 Years
Sex
All
01

Study 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).
Read the 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.
02

Conditions studied

  • Brain Arteriovenous Malformations

Keywords

  • Unruptured arteriovenous malformations
  • Multimodal CT
  • Machine learning
03

In context

Hemangioma

141 studies on the registry are indexed under Hemangioma; 16 are open to participants now.

This study's planned enrollment of 200 is above the median of 79 across 56 observational studies indexed under Hemangioma.

Browse Hemangioma studies →

Lead sponsor

Beijing Tiantan Hospital is the lead sponsor of 465 studies on the registry; 282 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
3 Years to 80 Years
Sexes eligible
All
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.

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

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.
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
200 participants (estimated)
Target follow-up
3 Years
Patient registry
Yes
06

What researchers measure

Primary outcomes

  1. Number of participants with rupture events

    Arteriovenous malformation rupture during follow-up before treatment

    Time frame: 3 years after enrollment

  2. 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.

    Time frame: 3 years after enrollment

  3. Number of participants with new onset neurological dysfunction

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

    Time frame: 3 years after enrollment

Secondary outcomes

  1. Number of participants receiving treatment

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

    Time frame: 3 years after enrollment

07

Study locations

4 of 4 sites recruiting
  • Beijing Tiantan Hospital, Capital Medical University
    Beijing, Beijing 100070, China
    • Shaosen Zhang, Doctor · Contact · longyoubafang@hotmail.com · +8618611284839
    • 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 · Principal investigator
    Recruiting
  • Beijing Hospital
    Beijing, Beijing 102249, China
    • Jun Lu, Doctor · Contact · lujun3655@bjhmoh.cn · 13521208691
    • Jun Lu, Doctor · Principal investigator
    Recruiting
  • The First Affiliated Hospital of Zhengzhou University
    Zhengzhou, Henan 450052, China
    • Yingwei Zhen, Doctor · Contact · zhenyw@aliyun.com · +8618739929265
    • Guosheng Zhou, Doctor · Principal investigator
    • Yingwei Zhen, Doctor · Principal investigator
    Recruiting
  • The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
    Nanjing, Jiangsu 210008, China
    • Zhiyong Shi, Doctor · Contact · szy1195156829@aliyun.com · +861501104692
    • Yongbo Yang, Doctor · Principal investigator
    • Zhiyong Shi, Doctor · Principal investigator
    Recruiting
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 7, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT05449106
Lead sponsor
Beijing Tiantan Hospital
Collaborators
Beijing Hospital, The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School, The First Affiliated Hospital of Zhengzhou University
Responsible party
Sponsor
First posted
Jul 8, 2022
Start date
May 25, 2022
Primary completion
May 25, 2027 (estimated)
Completion
May 25, 2032 (estimated)
Last update
Sep 7, 2023

Study contacts

Shaosen Zhang, Doctor
Contact
longyoubafang@hotmail.com
+8618611284839
Dong Zhang, Doctor
study chair · Beijing Tiantan Hospital, Beijing Hospital
Shaosen Zhang, Doctor
study director · Beijing Tiantan Hospital
Guosheng Zhou
principal investigator · The First Affiliated Hospital of Zhengzhou University
Yongbo Yang
principal investigator · The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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