Intracranial AneurysmNCT06456814
Epidemiological Insights Into the Formation, Progression, and Rupture of Intracranial Aneurysms: A Retrospective, Multi-Center Hospital-Based Study in China
An observational study of Intracranial Aneurysm and Subarachnoid Hemorrhage, Aneurysmal, run by Zhujiang Hospital at 1 site in China.
Trial summary
This is a retrospective, hospital-based and multi-center study aiming at investigating the potential exposures associated with the formation, progression, and rupture of intracranial aneurysms in Chinese population. Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Intracranial Aneurysm, Subarachnoid Hemorrhage, Aneurysmal, Cerebral Aneurysm
- How many people
- 30,000 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2010to 31 Dec 2026
- 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 18 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: The study population underwent cerebrovascular examinations, with the majority conducted in clinical settings and the minority for health screening purposes, sourced from real-world electronic medical record databases.
Who may be able to join
- IA diagnosis (ruptured or unruptured) or exclusion by digital subtractive angiography (DSA) or by cranial computed tomography angiography (CTA) / magnetic resonance angiography (MRA);
- Aged ≥ 18 and ≤ 18 years old;
- With complete demographic data including age and sex;
- With medical record archiving officially.
Who cannot join
- Missing data of age, sex or hypertensive status;
- Age <18 or >80 years;
- Pregnancy;
- With a history of intracranial arteriovenous malformation, Moyamoya, polycystic kidney disease, Ehlers-Danlos syndrome, Gronblad-Strandberg syndrome, or Marfan syndrome;
- Suspicion for dissecting or mycotic aneurysms or aneurysm-like lesions that were indistinguishable from the infundibulum, fenestration, dilation, or atherosclerotic remodeling on structural imaging scans.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Zhujiang Hospital
Guangzhou
Chuanzhi Duan, doctor_duan@163.com
About this study
Official title: Epidemiological Insights Into the Formation, Progression, and Rupture of Aneurysms: A Retrospective, Multi-Center Hospital-Based Study in China
This is a retrospective, hospital-based and multi-center study aiming at investigating the potential exposures associated with the formation, progression, and rupture of intracranial aneurysms in Chinese population.
Read the detailed description
A striking conflict exists between the fatal rupture of intracranial aneurysms (IA) and the passive approach to detecting IA through cerebrovascular examinations. This is attributed to a limited understanding of risk factors for IA incidence and the resulting lack of cost-effective IA screening.
This study aims to gain epidemiological insights into the exposures associated with the risk of IA incidence, including formation, progression, and rupture in the Chinese population. It integrates multi-modal data based on large-scale electronic medical records from high-volume stroke centers across China to investigate potential associations between various exposures and IA incidence.
Patients with anonymous and unique IDs were screened for the presence of IA by formal readings from digital subtraction angiography (DSA), cranial computed tomography angiography (CTA), or magnetic resonance angiography (MRA) conducted by two radiologists, which were then confirmed by two treating neurosurgeons using the raw images. Using natural language processing in conjunction with medical records and multi-modal data, patient exposures were extracted and assumed to be absent if no documentation was found across the databases.
Through a series of retrospective analyses, we aim to identify the exposures associated with IA incidence as much as possible to gather valuable insights for future prospective research.
- Conditions
- Intracranial Aneurysm, Subarachnoid Hemorrhage, Aneurysmal, Cerebral Aneurysm, Brain Aneurysm
- Keywords
- Intracranial aneurysm, Clinical epidemiology, Exposures
- Medical subject headings
- Intracranial Aneurysm, Subarachnoid Hemorrhage
What is being measured
The primary outcome is the main question the study is designed to answer.
Intracranial aneurysm
The presence or absence of IAs detected by digital subtractive angiography or by cranial computed tomography angiography / magnetic resonance angiography.
Measured: 2010.01.01-2024.06.01
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jun 2024
- Study start1 Jan 2010
- Primary completion1 Jun 2024
- Study completion31 Dec 2026 (estimated)
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 Zhujiang 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
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 30,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Zhujiang Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Beijing Tiantan Hospital, Guangdong Provincial People's Hospital, First Affiliated Hospital of Chongqing Medical University, The Affiliated Hospital Of Southwest Medical University
- Responsible party
- Principal investigator, Duan Chuanzhi, Zhujiang Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06456814
- Sponsor's protocol ID
- NCT20240606IA
- Status last verified
- Jun 2024
- First submitted
- 7 Jun 2024
- Last updated
- 13 Jun 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Lin J, Feng X, Wen Z, Huang C, Huang M, Huang J, Ge R, Xu A, Ma G, Shi H, Hu Y, Yuan H, Li C, Yi R, Jin Y, Liang S, Zhang X, Li X, Duan C. Association between triglyceride-glucose index and intracranial aneurysm rupture: findings from a retrospective study. Neurosurg Rev. 2025 Jun 21;48(1):521. doi: 10.1007/s10143-025-03680-1.
PubMed 40542179
Study at a glance
From the registry record, last updated by the sponsor on 13 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Epidemiological Insights Into the Formation, Progression, and Rupture of Aneurysms: A Retrospective, Multi-Center Hospital-Based Study in China
- ClinicalTrials.gov ID
- NCT06456814
- Acronym / sponsor ID
- NCT20240606IA
- Conditions
- Intracranial Aneurysm, Subarachnoid Hemorrhage, Aneurysmal, Cerebral Aneurysm, Brain Aneurysm
- Keywords
- Intracranial aneurysm, Clinical epidemiology, Exposures
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 30,000 participants (estimated)
- Lead sponsor
- Zhujiang HospitalUniversity, hospital or other
- Collaborators
- Beijing Tiantan Hospital, Guangdong Provincial People's Hospital, First Affiliated Hospital of Chongqing Medical University, The Affiliated Hospital Of Southwest Medical University
- Study start
- 1 Jan 2010 (actual)
- Primary completion
- 1 Jun 2024 (actual)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 13 Jun 2024 (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.
This is a retrospective, hospital-based and multi-center study aiming at investigating the potential exposures associated with the formation, progression, and rupture of intracranial aneurysms in Chinese population.
Detailed description
A striking conflict exists between the fatal rupture of intracranial aneurysms (IA) and the passive approach to detecting IA through cerebrovascular examinations. This is attributed to a limited understanding of risk factors for IA incidence and the resulting lack of cost-effective IA screening.
This study aims to gain epidemiological insights into the exposures associated with the risk of IA incidence, including formation, progression, and rupture in the Chinese population. It integrates multi-modal data based on large-scale electronic medical records from high-volume stroke centers across China to investigate potential associations between various exposures and IA incidence.
Patients with anonymous and unique IDs were screened for the presence of IA by formal readings from digital subtraction angiography (DSA), cranial computed tomography angiography (CTA), or magnetic resonance angiography (MRA) conducted by two radiologists, which were then confirmed by two treating neurosurgeons using the raw images. Using natural language processing in conjunction with medical records and multi-modal data, patient exposures were extracted and assumed to be absent if no documentation was found across the databases.
Through a series of retrospective analyses, we aim to identify the exposures associated with IA incidence as much as possible to gather valuable insights for future prospective research.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- The study population underwent cerebrovascular examinations, with the majority conducted in clinical settings and the minority for health screening purposes, sourced from real-world electronic medical record databases.
Key inclusion criteria (4 listed)
- IA diagnosis (ruptured or unruptured) or exclusion by digital subtractive angiography (DSA) or by cranial computed tomography angiography (CTA) / magnetic resonance angiography (MRA);
- Aged ≥ 18 and ≤ 18 years old;
- With complete demographic data including age and sex;
- With medical record archiving officially.
Key exclusion criteria (5 listed)
- Missing data of age, sex or hypertensive status;
- Age <18 or >80 years;
- Pregnancy;
- With a history of intracranial arteriovenous malformation, Moyamoya, polycystic kidney disease, Ehlers-Danlos syndrome, Gronblad-Strandberg syndrome, or Marfan syndrome;
- Suspicion for dissecting or mycotic aneurysms or aneurysm-like lesions that were indistinguishable from the infundibulum, fenestration, dilation, or atherosclerotic remodeling on structural imaging scans.
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
Intracranial aneurysm
Time frame: 2010.01.01-2024.06.01
The presence or absence of IAs detected by digital subtractive angiography or by cranial computed tomography angiography / magnetic resonance angiography.
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 13 Jun 2024.
- Derived from this study: PubMed 40542179Lin J, Feng X, Wen Z, Huang C, Huang M, Huang J, Ge R, Xu A, Ma G, Shi H, Hu Y, Yuan H, Li C, Yi R, Jin Y, Liang S, Zhang X, Li X, Duan C. Association between triglyceride-glucose index and intracranial aneurysm rupture: findings from a retrospective study. Neurosurg Rev. 2025 Jun 21;48(1):521. doi: 10.1007/s10143-025-03680-1.
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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.
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 and Subarachnoid Hemorrhage, Aneurysmal, run by Zhujiang 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 5 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 13 Jun 2024. 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?
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 Chuanzhi Duan, MD, PhD (15622311746, doctor_duanzj@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Intracranial aneurysm (time frame: 2010.01.01-2024.06.01). 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 NCT06456814, 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 13 Jun 2024; AzTrials last refreshed its copy on 8 Nov 2026.