Intracranial AneurysmNCT04872842
Establishment of Online Registration Platform for Unruptured Intracranial Aneurysms Based on 100 Regional Medical Centers in China and Population Follow-up Study
An observational study of Intracranial Aneurysm, run by Beijing Tiantan Hospital at 1 site in China.
Trial summary
In this study, 20 regional neurosurgery centers across the country will be included, and the study cohort will be constructed on the basis of the IARP-CP cohort.The artificial intelligence platform was used to analyze the clinical, morphological, hemodynamics, aneurysm wall characteristics and other factors of… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Intracranial Aneurysm
- What is being tested?
- Obervation
- How many people
- 1,000 participants
- Where
- 1 siteChina
- Study dates
- 1 Sep 2021to 1 May 2022
- How long will I take part?
- 2 Years
- 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 18 to 75 years
- All sexes
- Adult, Older adult
Study population: Chinese
Who may be able to join
- 18-75 years old;
- At least one unruptured intracranial aneurysm was found by CTA;
- No relevant symptoms, receiving non-operative and conservative observation treatment;
- Signing the informed consent.
Who cannot join
- Other cerebrovascular structural lesions (such as cerebrovascular malformation and arteriovenous fistula) or craniocerebral tumors;
- Fusiform or dissecting aneurysms;
- Traumatic, mycotic and atrial myxoma associated aneurysms;
- Suffering from systemic connective tissue diseases, such as polycystic kidney disease;
- Expectant survival of no more than 3 years due to other diseases or poor general conditions;
- Patients refuse to follow up or cannot communicate with them due to mental diseases;
- Pregnant women or participating in other aneurysm related studies.
Trial locations and contacts
1 site in 1 country.
About this study
In this study, 20 regional neurosurgery centers across the country will be included, and the study cohort will be constructed on the basis of the IARP-CP cohort.The artificial intelligence platform was used to analyze the clinical, morphological, hemodynamics, aneurysm wall characteristics and other factors of unruptured aneurysms, as well as the relationship between these factors and the risk of aneurysm instability, seek the potential risk factors, and finally establish a multi-dimensional prediction model of rupture risk of intracranial aneurysms.
- Conditions
- Intracranial Aneurysm
- Being tested
- Obervation
- Keywords
- intracranial aneurysm, online registration platform, artificial intelligence, multidimensional model
- Medical subject headings
- Intracranial Aneurysm
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ObervationOther
This study is an observational study without any intervention
| Study group | Role | What they receive |
|---|---|---|
| unstable intracranial aneurysms | Unstable intracranial aneurysms are defined as the intracranial aneurysms that grows or ruptures. Receives: Other: Obervation | |
| stable intracranial aneurysms | Stable intracranial aneurysms are defined as the intracranial aneurysms that have no significant morphological changes. Receives: Other: Obervation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Aneurysm rupture
Measured: 2 years
Secondary outcomes (1)
Aneurysm growth
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 May 2021
- Study start1 Sep 2021
- Primary completion1 Mar 2022
- Study completion1 May 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Intracranial AneurysmStudies 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
- 1,000 participants (actual)
- Target duration
- 2 Years
Sponsor and investigators
- Lead sponsor
- Beijing Tiantan Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Beijing Hospital, Peking University Third Hospital, Beijing Sanbo Brain Hospital, Beijing Chao Yang Hospital, Binzhou Renmin Hospital, Fujian Medical University Union Hospital, First Affiliated Hospital of Fujian Medical University, Guangzhou Red Cross Hospital, The First Affiliated Hospital of Haerbin Medical University, The Affiliated Hospital of Qingdao University, Shanxi Provincial People's Hospital, Beijing Tsinghua Changgeng Hospital, RenJi Hospital, Sichuan Provincial People's Hospital, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, Yan'an Affiliated Hospital of Kunming Medical University, Beijing Unimed Technology Company
- Responsible party
- Principal investigator, Wang Shuo, Beijing Tiantan Hospital
- Investigators
- Shuo Wang, MD, Principal investigator, Beijing Tiantan Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04872842
- Sponsor's protocol ID
- 82071296
- Status last verified
- Nov 2022
- First submitted
- 22 Apr 2021
- Last updated
- 8 Nov 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Publications
Liu Q, Li J, Zhang Y, Leng X, Mossa-Basha M, Levitt MR, Wang S, Zhu C. Association of calcium channel blockers with lower incidence of intracranial aneurysm rupture and growth in hypertensive patients. J Neurosurg. 2023 Jan 27;139(3):651-660. doi: 10.3171/2022.12.JNS222428. Print 2023 Sep 1.
PubMed 36708539
Study at a glance
From the registry record, last updated by the sponsor on 8 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Establishment of Online Registration Platform for Unruptured Intracranial Aneurysms Based on 100 Regional Medical Centers in China and Population Follow-up Study
- ClinicalTrials.gov ID
- NCT04872842
- Acronym / sponsor ID
- 82071296
- Conditions
- Intracranial Aneurysm
- Keywords
- intracranial aneurysm, online registration platform, artificial intelligence, multidimensional model
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,000 participants (actual)
- Lead sponsor
- Beijing Tiantan HospitalUniversity, hospital or other
- Collaborators
- Beijing Hospital, Peking University Third Hospital, Beijing Sanbo Brain Hospital, Beijing Chao Yang Hospital, Binzhou Renmin Hospital, Fujian Medical University Union Hospital, First Affiliated Hospital of Fujian Medical University, Guangzhou Red Cross Hospital, The First Affiliated Hospital of Haerbin Medical University, The Affiliated Hospital of Qingdao University, Shanxi Provincial People's Hospital, Beijing Tsinghua Changgeng Hospital, RenJi Hospital, Sichuan Provincial People's Hospital, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, Yan'an Affiliated Hospital of Kunming Medical University, Beijing Unimed Technology Company
- Study start
- 1 Sep 2021 (actual)
- Primary completion
- 1 Mar 2022 (actual)
- Study completion
- 1 May 2022 (actual)
- First posted
- 5 May 2021 (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.
In this study, 20 regional neurosurgery centers across the country will be included, and the study cohort will be constructed on the basis of the IARP-CP cohort.The artificial intelligence platform was used to analyze the clinical, morphological, hemodynamics, aneurysm wall characteristics and other factors of unruptured aneurysms, as well as the relationship between these factors and the risk of aneurysm instability, seek the potential risk factors, and finally establish a multi-dimensional prediction model of rupture risk of intracranial aneurysms.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 2 Years
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| unstable intracranial aneurysms | – | Other: ObervationUnstable intracranial aneurysms are defined as the intracranial aneurysms that grows or ruptures. |
| stable intracranial aneurysms | – | Other: ObervationStable intracranial aneurysms are defined as the intracranial aneurysms that have no significant morphological changes. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Chinese
Key inclusion criteria (4 listed)
- 18-75 years old;
- At least one unruptured intracranial aneurysm was found by CTA;
- No relevant symptoms, receiving non-operative and conservative observation treatment;
- Signing the informed consent.
Key exclusion criteria (7 listed)
- Other cerebrovascular structural lesions (such as cerebrovascular malformation and arteriovenous fistula) or craniocerebral tumors;
- Fusiform or dissecting aneurysms;
- Traumatic, mycotic and atrial myxoma associated aneurysms;
- Suffering from systemic connective tissue diseases, such as polycystic kidney disease;
- Expectant survival of no more than 3 years due to other diseases or poor general conditions;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ObervationThis study is an observational study without any intervention | Other | stable intracranial aneurysms, unstable intracranial aneurysms |
Primary outcome
Aneurysm rupture
Time frame: 2 years
1 secondary outcome
Aneurysm growth
Time frame: 2 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Nov 2022.
- Derived from this study: PubMed 36708539Liu Q, Li J, Zhang Y, Leng X, Mossa-Basha M, Levitt MR, Wang S, Zhu C. Association of calcium channel blockers with lower incidence of intracranial aneurysm rupture and growth in hypertensive patients. J Neurosurg. 2023 Jan 27;139(3):651-660. doi: 10.3171/2022.12.JNS222428. Print 2023 Sep 1.
- Individual participant dataSharing planned: Yes
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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.
Shuo Wang, MD principal investigator
Beijing Tiantan Hospital
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 Intracranial Aneurysm, run by Beijing Tiantan Hospital 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 4 inclusion and 7 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: finished, as of the sponsor's last update on 8 Nov 2022. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Aneurysm rupture (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04872842, which also lists 1 linked publication.
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 8 Nov 2022.