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NCT Number: NCT05449106

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

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).

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Key information

Age range

3 year–80 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Beijing Hospital, Beijing, Beijing Municipality, China

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About this study

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:

  • Morphological, structural and imaging histological signal analysis based on multimodal CT to study the relationship between imaging features and different clinical outcomes of bAVMs.
  • 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.
  • Based on multimodal CT and deep learning algorithms to create an automated segmentation model for bAVMs and a prediction model for distinct clinical outcomes.
  • To compare the efficacy of multimodal CT and MRI in evaluating the clinical outcomes of unruptured cerebral arteriovenous malformations.

The obtained patient information includes:

  • Baseline information
  • CT images: including non-contrast CT(NCCT), CT Angiography, CT perfusion
  • 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)
  • Digital subtraction angiography(DSA, optional)
  • 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:

  • Hemorrhage events associated with bAVMs, ensuring by CT scan;
  • New epilepsy symptoms or exacerbations, ensuring by consultation or EEG ;
  • New neurological dysfunction(including motor dysfunction, cognitive dysfunction, etc), ensuring by consultation, physical examination or any radiology examination.

Inclusion criteria

  • Patients with confirmed diagnosis of bAVMs in the cerebrum, basal ganglia, thalamus, corpus callosum, cerebellum and brainstem;
  • Patients with no history of previous bAVM related hemorrhage confirmed by CT examination, or have radiographic examination completed prior to the hemorrhage.
  • Patients with radiographic examinations before any treatment;

Exclusion criteria

.

  • Patients with simple arteriovenous fistula;
  • Patients with combined dural arteriovenous fistula;
  • Arteriovenous malformations occurring in the spinal cord;
  • Pregnant patients were not included in this study.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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.

Treatment and study plan

Primary outcomes

  1. Number of participants with rupture events

    Time frame: 3 years after enrollment

    Arteriovenous malformation rupture during follow-up before treatment

  2. Number of participants with epilepsy Progression

    Time frame: 3 years after enrollment

    Progression of seizure symptoms during follow-up, including but not limited to more frequent seizures, worsening of symptoms, etc.

  3. Number of participants with new onset neurological dysfunction

    Time frame: 3 years after enrollment

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

Secondary outcomes

  1. Number of participants receiving treatment

    Time frame: 3 years after enrollment

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

Study contacts

Contact information is provided by the study sponsor or research team.

Shaosen Zhang, Doctor

CONTACT

[email protected]

+8618611284839

Sponsors and collaborators

Lead sponsor

Beijing Tiantan Hospital

Other

Collaborators

  • Beijing Hospital
  • The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
  • The First Affiliated Hospital of Zhengzhou University

Registry information

Official study title

Evaluation of Clinical Outcomes of Unruptured Brain Arteriovenous Malformations Treated With Medical Management Alone Based on Multimodal Computer Tomography: A Long-term Multicenter Prospective Cohort Study

Important dates

Study start
2022
Primary completion
2027
Study completion
2032
First posted
Jul 8, 2022
Registry last updated
Sep 7, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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