Cerebral Arteriovenous MalformationDOPANCT04593966
Pediatric and Adult Cerebral Arteriovenous Malformation Neurofunctional Outcomes
An observational study of Cerebral Arteriovenous Malformation, run by yuanli Zhao at 1 site in China.
Trial summary
Cerebral Arteriovenous malformations (AVMs) are abnormal tangles which are usually believed congenital. AVM can cause different symptoms depending on where it is located, but the most common symptoms are intracranial hemorrhage and seizure. Read more about this study
- Who is it for?
- Ages 1 year to 80 years
- Conditions the study is for
- Cerebral Arteriovenous Malformation
- How many people
- 300 participants
- Where
- 1 siteChina
- Study dates
- 1 Apr 2012to Dec 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
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 1 year to 80 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients with brain arteriovenous malformation which located in eloquent area.
Who may be able to join
- The diagnosis of AVM was confirmed with digital subtraction angiography (DSA) and/or magnetic resonance imaging(MRI).
- Patients had underwent interventions in our institution.
- AVMs were located in eloquent area.
Who cannot join
- Patients with multiple AVMs.
- Patients with hereditary hemorrhagic telangiectasia (HHT).
- Patients with missing clinical and imaging data.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Capital medical university affiliated Beijing Tiantan hospital
Beijing, Beijing Municipality, 101100
Ruinan Li, MD, +8618511287842, 70akagi@gmail.com
About this study
Official title: Differences of Long-term Neurofunctional Outcomes in Pediatric and Adult Eloquent Region Cerebral Arteriovenous Malformation
Cerebral Arteriovenous malformations (AVMs) are abnormal tangles which are usually believed congenital. AVM can cause different symptoms depending on where it is located, but the most common symptoms are intracranial hemorrhage and seizure. Outcomes of AVM patients can be very different due to factors like the location of lesion, age, sex etc. Generally, more early the intervention was taken, the risk of adverse events would be lower. But the selection of surgical timing for pediatric AVM patients is hard to judge, due to children's cerebral vessels angioarchitecture can be still developing with their age. Some previous studies indicated that there is no difference in intervention outcomes between pediatric and adult AVM patients, so pediatric patients should undergo more aggressive intervention. DOPA study aims to compare the clinical intervention outcomes of both pediatric and adult patients with eloquent region cerebral arteriovenous malformations, helping to determine the treatment strategy.
Read the detailed description
Follow-up: In the investigators' neurosurgical center, follow-up was conducted for all participants at the first 3-6 months and annually after discharge by clinical visit and telephone interview.
Study overview: DOPA will aim on outcomes of both pediatric and adult AVMs patients who underwent intervention in investigators' institution. Intervention strategies contains microsurgical resection, embolization, embolization + radiosurgery, and single-stage hybrid surgery (embolization + resection). Outcomes will be measured by a neurologist using Modified Rankin Scale (mRs). Participants' mRs<2 will be considered as a good outcome and investigators will keep follow-up with every patient for at least 3 years.
Sample size: About 300 patients will be enrolled in this study, and adults and children will account for half. All kinds of intervention will be included. The distribution of different strategies is excepted as: 30% resection, 20% embolization, 30% embolization + radiosurgery and 20% hybrid surgery.
Study endpoints: The patients' mRs, occlusion rate and complication will be evaluated at 2 weeks, discharge from hospital, 1 year and 3 years after the first-time intervention.
- Conditions
- Cerebral Arteriovenous Malformation
- Medical subject headings
- Intracranial Arteriovenous Malformations
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Pediatric AVM | 1. AVM patients' age under 18-years-old who underwent intervention in investigators' institution. 2. Patients' lesions were located in eloquent and confirmed by image. | |
| Adult AVM | 1. AVM patients' age over 18-years-old who underwent intervention in investigators' institution. 2. Patients' lesions were located in eloquent and confirmed by image. |
What is being measured
The primary outcome is the main question the study is designed to answer.
modified Ranking Scale score at 2 weeks after the operation
The scale runs from 0-6, running from perfect health without symptoms to death. 0 - No symptoms.
No significant disability. Able to carry out all usual activities, despite some symptoms.
Slight disability. Able to look after own affairs without assistance, but unable to carry out all previous activities.
Moderate disability. Requires some help, but able to walk unassisted. Moderately severe disability. Unable to attend to own bodily needs without assistance, and unable to walk unassisted.
Severe disability. Requires constant nursing care and attention, bedridden, incontinent.
Dead
Measured: 2 weeks
modified Ranking Scale score when discharge
The scale runs from 0-6, running from perfect health without symptoms to death. 0 - No symptoms.
No significant disability. Able to carry out all usual activities, despite some symptoms.
Slight disability. Able to look after own affairs without assistance, but unable to carry out all previous activities.
Moderate disability. Requires some help, but able to walk unassisted. Moderately severe disability. Unable to attend to own bodily needs without assistance, and unable to walk unassisted.
Severe disability. Requires constant nursing care and attention, bedridden, incontinent.
Dead
Measured: Discharge (assessed up to 10 days)
modified Ranking Scale score at 1 years after the operation
The scale runs from 0-6, running from perfect health without symptoms to death. 0 - No symptoms.
No significant disability. Able to carry out all usual activities, despite some symptoms.
Slight disability. Able to look after own affairs without assistance, but unable to carry out all previous activities.
Moderate disability. Requires some help, but able to walk unassisted. Moderately severe disability. Unable to attend to own bodily needs without assistance, and unable to walk unassisted.
Severe disability. Requires constant nursing care and attention, bedridden, incontinent.
Dead
Measured: 1 years
modified Ranking Scale score at 3 years after the operation
The scale runs from 0-6, running from perfect health without symptoms to death. 0 - No symptoms.
No significant disability. Able to carry out all usual activities, despite some symptoms.
Slight disability. Able to look after own affairs without assistance, but unable to carry out all previous activities.
Moderate disability. Requires some help, but able to walk unassisted. Moderately severe disability. Unable to attend to own bodily needs without assistance, and unable to walk unassisted.
Severe disability. Requires constant nursing care and attention, bedridden, incontinent.
Dead
Measured: 3 years
Secondary outcomes (1)
Obliteration rate
Confirmed by postoperative DSA or MRI/magnetic resonance angiography
Measured: At least 1 year, up to 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Oct 2020
- Study start1 Apr 2012
- Primary completionNov 2024 (estimated)
- Study completionDec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cerebral Arteriovenous MalformationStudies of the same condition, open and under way.
- 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
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- yuanli Zhao
- Sponsor type
- University, hospital or other
- Collaborators
- Peking University International Hospital
- Responsible party
- Sponsor-investigator, yuanli Zhao, Beijing Tiantan Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04593966
- Sponsor's protocol ID
- KY 2019/0917
- Acronym
- DOPA
- Status last verified
- Oct 2020
- First submitted
- 10 Sep 2020
- Last updated
- 20 Oct 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Differences of Long-term Neurofunctional Outcomes in Pediatric and Adult Eloquent Region Cerebral Arteriovenous Malformation
- ClinicalTrials.gov ID
- NCT04593966
- Acronym / sponsor ID
- DOPA / KY 2019/0917
- Conditions
- Cerebral Arteriovenous Malformation
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- yuanli ZhaoUniversity, hospital or other
- Collaborators
- Peking University International Hospital
- Study start
- 1 Apr 2012 (actual)
- Primary completion
- Nov 2024 (estimated)
- Study completion
- Dec 2024 (estimated)
- First posted
- 20 Oct 2020 (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.
Cerebral Arteriovenous malformations (AVMs) are abnormal tangles which are usually believed congenital. AVM can cause different symptoms depending on where it is located, but the most common symptoms are intracranial hemorrhage and seizure. Outcomes of AVM patients can be very different due to factors like the location of lesion, age, sex etc. Generally, more early the intervention was taken, the risk of adverse events would be lower. But the selection of surgical timing for pediatric AVM patients is hard to judge, due to children's cerebral vessels angioarchitecture can be still developing with their age. Some previous studies indicated that there is no difference in intervention outcomes between pediatric and adult AVM patients, so pediatric patients should undergo more aggressive intervention. DOPA study aims to compare the clinical intervention outcomes of both pediatric and adult patients with eloquent region cerebral arteriovenous malformations, helping to determine the treatment strategy.
Detailed description
Follow-up: In the investigators' neurosurgical center, follow-up was conducted for all participants at the first 3-6 months and annually after discharge by clinical visit and telephone interview.
Study overview: DOPA will aim on outcomes of both pediatric and adult AVMs patients who underwent intervention in investigators' institution. Intervention strategies contains microsurgical resection, embolization, embolization + radiosurgery, and single-stage hybrid surgery (embolization + resection). Outcomes will be measured by a neurologist using Modified Rankin Scale (mRs). Participants' mRs<2 will be considered as a good outcome and investigators will keep follow-up with every patient for at least 3 years.
Sample size: About 300 patients will be enrolled in this study, and adults and children will account for half. All kinds of intervention will be included. The distribution of different strategies is excepted as: 30% resection, 20% embolization, 30% embolization + radiosurgery and 20% hybrid surgery.
Study endpoints: The patients' mRs, occlusion rate and complication will be evaluated at 2 weeks, discharge from hospital, 1 year and 3 years after the first-time intervention.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pediatric AVM | – | –1. AVM patients' age under 18-years-old who underwent intervention in investigators' institution. 2. Patients' lesions were located in eloquent and confirmed by image. |
| Adult AVM | – | –1. AVM patients' age over 18-years-old who underwent intervention in investigators' institution. 2. Patients' lesions were located in eloquent and confirmed by image. |
Who may qualify
- Ages
- 1 year to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients with brain arteriovenous malformation which located in eloquent area.
Key inclusion criteria (3 listed)
- The diagnosis of AVM was confirmed with digital subtraction angiography (DSA) and/or magnetic resonance imaging(MRI).
- Patients had underwent interventions in our institution.
- AVMs were located in eloquent area.
Key exclusion criteria (3 listed)
- Patients with multiple AVMs.
- Patients with hereditary hemorrhagic telangiectasia (HHT).
- Patients with missing clinical and imaging data.
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
modified Ranking Scale score at 2 weeks after the operation
Time frame: 2 weeks
The scale runs from 0-6, running from perfect health without symptoms to death. 0 - No symptoms. No significant disability. Able to carry out all usual activities, despite some symptoms. Slight disability. Able to look after own affairs without assistance, but unable to carry out all previous activities. Moderate disability. Requires some help, but able to walk unassisted. Moderately severe disability. Unable to attend to own bodily needs without assistance, and unable to walk unassisted. Severe disability. Requires constant nursing care and attention, bedridden, incontinent. Dead
modified Ranking Scale score when discharge
Time frame: Discharge (assessed up to 10 days)
The scale runs from 0-6, running from perfect health without symptoms to death. 0 - No symptoms. No significant disability. Able to carry out all usual activities, despite some symptoms. Slight disability. Able to look after own affairs without assistance, but unable to carry out all previous activities. Moderate disability. Requires some help, but able to walk unassisted. Moderately severe disability. Unable to attend to own bodily needs without assistance, and unable to walk unassisted. Severe disability. Requires constant nursing care and attention, bedridden, incontinent. Dead
modified Ranking Scale score at 1 years after the operation
Time frame: 1 years
The scale runs from 0-6, running from perfect health without symptoms to death. 0 - No symptoms. No significant disability. Able to carry out all usual activities, despite some symptoms. Slight disability. Able to look after own affairs without assistance, but unable to carry out all previous activities. Moderate disability. Requires some help, but able to walk unassisted. Moderately severe disability. Unable to attend to own bodily needs without assistance, and unable to walk unassisted. Severe disability. Requires constant nursing care and attention, bedridden, incontinent. Dead
modified Ranking Scale score at 3 years after the operation
Time frame: 3 years
The scale runs from 0-6, running from perfect health without symptoms to death. 0 - No symptoms. No significant disability. Able to carry out all usual activities, despite some symptoms. Slight disability. Able to look after own affairs without assistance, but unable to carry out all previous activities. Moderate disability. Requires some help, but able to walk unassisted. Moderately severe disability. Unable to attend to own bodily needs without assistance, and unable to walk unassisted. Severe disability. Requires constant nursing care and attention, bedridden, incontinent. Dead
1 secondary outcome
Obliteration rate
Time frame: At least 1 year, up to 3 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Oct 2020.
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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. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cerebral Arteriovenous Malformation, run by yuanli Zhao at 1 site 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 3 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: status not confirmed, as of the sponsor's last update on 20 Oct 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ruinan Li, MD (+8618511287842, 70akagi@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
modified Ranking Scale score at 2 weeks after the operation (time frame: 2 weeks). The study lists 4 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 20 Oct 2020.