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

NCT05449106 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 200

Last updated 2023-09-07

No results posted yet for this 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).

Conditions

  • Brain Arteriovenous Malformations

Sponsors & Collaborators

  • Beijing Hospital

    collaborator OTHER_GOV

  • The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School

    collaborator OTHER

  • The First Affiliated Hospital of Zhengzhou University

    collaborator OTHER

  • Beijing Tiantan Hospital

    lead OTHER

Principal Investigators

  • Dong Zhang, Doctor · Beijing Tiantan Hospital, Beijing Hospital

  • Shaosen Zhang, Doctor · Beijing Tiantan Hospital

  • Guosheng Zhou · The First Affiliated Hospital of Zhengzhou University

  • Yongbo Yang · The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School

Eligibility

Min Age
3 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-05-25
Primary Completion
2027-05-25
Completion
2032-05-25

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05449106 on ClinicalTrials.gov