NCT05449106

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:

  1. 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. 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. 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. 4.Hemorrhage events associated with bAVMs
  5. 5.New epilepsy symptoms or exacerbations
  6. 6.New neurological dysfunction(including motor dysfunction, cognitive dysfunction, etc).

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
200

participants targeted

Target at P75+ for all trials

Timeline
74mo left

Started May 2022

Longer than P75 for all trials

Geographic Reach
1 country

4 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress40%
May 2022May 2032

Study Start

First participant enrolled

May 25, 2022

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

July 4, 2022

Completed
4 days until next milestone

First Posted

Study publicly available on registry

July 8, 2022

Completed
4.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 25, 2027

Expected
5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

May 25, 2032

Last Updated

September 7, 2023

Status Verified

August 1, 2023

Enrollment Period

5 years

First QC Date

July 4, 2022

Last Update Submit

September 5, 2023

Conditions

Brain Arteriovenous Malformations

Keywords

Unruptured arteriovenous malformationsMultimodal CTMachine learning

Outcome Measures

Primary Outcomes (3)

  • 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 Outcomes (1)

  • Number of participants receiving treatment

    3 years after enrollment

Eligibility Criteria

Age3 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Beijing Tiantan Hospital, Capital Medical University

Beijing, Beijing Municipality, 100070, China

RECRUITING

Beijing Hospital

Beijing, Beijing Municipality, 102249, China

RECRUITING

The First Affiliated Hospital of Zhengzhou University

Zhengzhou, Henan, 450052, China

RECRUITING

The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School

Nanjing, Jiangsu, 210008, China

RECRUITING

Study Officials

  • Dong Zhang, Doctor

    Beijing Tiantan Hospital, Beijing Hospital

    STUDY CHAIR

  • Shaosen Zhang, Doctor

    Beijing Tiantan Hospital

    STUDY DIRECTOR

  • Guosheng Zhou

    The First Affiliated Hospital of Zhengzhou University

    PRINCIPAL INVESTIGATOR

  • Yongbo Yang

    The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Shaosen Zhang, Doctor

CONTACT

+8618611284839longyoubafang@hotmail.com

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
3 Years
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 4, 2022

First Posted

July 8, 2022

Study Start

May 25, 2022

Primary Completion (Estimated)

May 25, 2027

Study Completion (Estimated)

May 25, 2032

Last Updated

September 7, 2023

Record last verified: 2023-08

Locations

CN(4)