Clinical trial NCT06456814: Epidemiological Insights Into the Formation, Progression, and Rupture of Intracranial Aneurysms: A Retrospective, Multi-Center Hospital-Based Study in China
Official title: Epidemiological Insights Into the Formation, Progression, and Rupture of Aneurysms: A Retrospective, Multi-Center Hospital-Based Study in China
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Intracranial Aneurysm
Subarachnoid Hemorrhage, Aneurysmal
Cerebral Aneurysm
Brain Aneurysm
Keywords: Intracranial aneurysm
Clinical epidemiology
Exposures
Lead sponsor: Zhujiang Hospital
Sponsor class: OTHER
Collaborators: name: Beijing Tiantan Hospital
name: Guangdong Provincial People's Hospital
name: First Affiliated Hospital of Chongqing Medical University
name: The Affiliated Hospital Of Southwest Medical University
First posted: 2024-06-13
Enrollment: 30000
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
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.

Brief 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.

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.

Eligibility criteria: Inclusion Criteria:

1. IA diagnosis (ruptured or unruptured) or exclusion by digital subtractive angiography (DSA) or by cranial computed tomography angiography (CTA) / magnetic resonance angiography (MRA);
2. Aged ≥ 18 and ≤ 18 years old;
3. With complete demographic data including age and sex;
4. With medical record archiving officially.

Exclusion Criteria:

1. Missing data of age, sex or hypertensive status;
2. Age \<18 or \>80 years;
3. Pregnancy;
4. With a history of intracranial arteriovenous malformation, Moyamoya, polycystic kidney disease, Ehlers-Danlos syndrome, Gronblad-Strandberg syndrome, or Marfan syndrome;
5. 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.

Primary outcomes:
measure: Intracranial aneurysm
timeFrame: 2010.01.01-2024.06.01
Secondary outcomes:
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Zhujiang Hospital
Study officials:
References: