Brain Arteriovenous MalformationsNCT05449106
Evaluation of Clinical Outcomes of Unruptured bAVMs Treated With Medical Management Alone Based on Multimodal CT
An observational study of Brain Arteriovenous Malformations, run by Beijing Tiantan Hospital at 4 sites in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 3 to 80 years
- Conditions the study is for
- Brain Arteriovenous Malformations
- How many people
- 200 participants
- Where
- 4 sitesChina
- Study dates
- 25 May 2022to 25 May 2032
- How long will I take part?
- 3 Years
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 3 to 80 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
4 sites in 1 country. Contact the study team or a site near you to ask about taking part.
China4 sites, 4 recruiting
- Recruiting
Beijing Tiantan Hospital, Capital Medical University
Beijing, Beijing Municipality, 100070
Shaosen Zhang, Doctor, +8618611284839, longyoubafang@hotmail.com
Dong Zhang, Doctor
- Recruiting
Beijing Hospital
Beijing, Beijing Municipality, 102249
Jun Lu, Doctor, 13521208691, lujun3655@bjhmoh.cn
Jun Lu, Doctor
- Recruiting
The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
Nanjing, Jiangsu, 210008
Zhiyong Shi, Doctor, +861501104692, szy1195156829@aliyun.com
Yongbo Yang, Doctor
- Recruiting
The First Affiliated Hospital of Zhengzhou University
Zhengzhou, Henan, 450052
Yingwei Zhen, Doctor, +8618739929265, zhenyw@aliyun.com
Guosheng Zhou, Doctor
About this study
Official 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
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:
Read more
- Morphological, structural and imaging histological signal analysis based on multimodal CT to explore 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.
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:
- Hemorrhage events associated with bAVMs
- New epilepsy symptoms or exacerbations
- 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:
- 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.
- Conditions
- Brain Arteriovenous Malformations
- Keywords
- Unruptured arteriovenous malformations, Multimodal CT, Machine learning
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants with rupture events
Arteriovenous malformation rupture during follow-up before treatment
Measured: 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.
Measured: 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.
Measured: 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
Measured: 3 years after enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jul 2022
- Study start25 May 2022
- Primary completion25 May 2027 (estimated)
- Study completion25 May 2032 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Brain Arteriovenous MalformationsStudies of the same condition, open and under way.
- More trials run by Beijing Tiantan HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 200 participants (estimated)
- Target duration
- 3 Years
Sponsor and investigators
- Lead sponsor
- Beijing Tiantan Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Beijing Hospital, The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School, The First Affiliated Hospital of Zhengzhou University
- Responsible party
- Sponsor
- Investigators
- Dong Zhang, Doctor, Study chair, Beijing Tiantan Hospital, Beijing HospitalShaosen Zhang, Doctor, Study director, Beijing Tiantan HospitalGuosheng Zhou, Principal investigator, The First Affiliated Hospital of Zhengzhou UniversityYongbo Yang, Principal investigator, The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05449106
- Sponsor's protocol ID
- KY2022-054-02
- Status last verified
- Aug 2023
- First submitted
- 4 Jul 2022
- Last updated
- 7 Sep 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT05449106
- Acronym / sponsor ID
- KY2022-054-02
- Conditions
- Brain Arteriovenous Malformations
- Keywords
- Unruptured arteriovenous malformations, Multimodal CT, Machine learning
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Beijing Tiantan HospitalUniversity, hospital or other
- Collaborators
- Beijing Hospital, The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School, The First Affiliated Hospital of Zhengzhou University
- Study start
- 25 May 2022 (actual)
- Primary completion
- 25 May 2027 (estimated)
- Study completion
- 25 May 2032 (estimated)
- First posted
- 8 Jul 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- Morphological, structural and imaging histological signal analysis based on multimodal CT to explore 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.
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:
- Hemorrhage events associated with bAVMs
- New epilepsy symptoms or exacerbations
- New neurological dysfunction(including motor dysfunction, cognitive dysfunction, etc).
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:
- 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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 3 Years
Who may qualify
- Ages
- 3 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Number of participants with rupture events
Time frame: 3 years after enrollment
Arteriovenous malformation rupture during follow-up before treatment
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.
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.
1 secondary outcome
Number of participants receiving treatment
Time frame: 3 years after enrollment
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Sep 2023.
Related trials for Brain Arteriovenous Malformations
Not yet recruitingObservational study
Twenty-five Years of Advanced RadioTherapy at San Raffaele Hospital
Malignant Tumor, Benign Neoplasm
RecruitingPhase 2
UCSD Image-Guided Cognitive-Sparing Radiosurgery for Intracranial Lesions
Brain Metastases, Adult, Neurocognitive Function
Active, not recruitingObservational study
Florida Cerebrovascular Disease Biorepository and Genomics Center
Cerebrovascular Disease, Ischemic Stroke
RecruitingObservational study
Liquid Biopsies for the Detection of Somatic Mutations in bAVMs
Brain Arterial Disease
RecruitingObservational study
Rapid Evacuation and Access of Cerebral Hemorrhage Registry
Intracerebral Hemorrhage
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
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
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Brain Arteriovenous Malformations, run by Beijing Tiantan Hospital at 4 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 7 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Shaosen Zhang, Doctor (+8618611284839, longyoubafang@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of participants with rupture events (time frame: 3 years after enrollment). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Sep 2023.