Actively Recruiting

Age: 3Years - 80Years
All Genders
NCT05449106

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

Led by Beijing Tiantan Hospital · Updated on 2023-09-07

200

Participants Needed

4

Research Sites

521 weeks

Total Duration

On this page

Sponsors

B

Beijing Tiantan Hospital

Lead Sponsor

B

Beijing Hospital

Collaborating Sponsor

AI-Summary

What this Trial Is About

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).

CONDITIONS

Official Title

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

Who Can Participate

Age: 3Years - 80Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • 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
Not Eligible

You will not qualify if you...

  • 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.

AI-Screening

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Trial Site Locations

Total: 4 locations

1

Beijing Tiantan Hospital, Capital Medical University

Beijing, Beijing Municipality, China, 100070

Actively Recruiting

2

Beijing Hospital

Beijing, Beijing Municipality, China, 102249

Actively Recruiting

3

The First Affiliated Hospital of Zhengzhou University

Zhengzhou, Henan, China, 450052

Actively Recruiting

4

The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School

Nanjing, Jiangsu, China, 210008

Actively Recruiting

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Research Team

S

Shaosen Zhang, Doctor

CONTACT

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

0

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