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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06456814
Other study ID # NCT20240606IA
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date January 1, 2010
Est. completion date December 31, 2026

Study information

Verified date June 2024
Source Zhujiang Hospital
Contact Chuanzhi Duan, MD, PhD
Phone 15622311746
Email doctor_duanzj@163.com
Is FDA regulated No
Health authority
Study type Observational

Clinical 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.


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 30000
Est. completion date December 31, 2026
Est. primary completion date June 1, 2024
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 80 Years
Eligibility 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.

Study Design


Related Conditions & MeSH terms


Locations

Country Name City State
China Zhujiang Hospital Guangzhou

Sponsors (5)

Lead Sponsor Collaborator
Zhujiang Hospital Beijing Tiantan Hospital, First Affiliated Hospital of Chongqing Medical University, Guangdong Provincial People's Hospital, The Affiliated Hospital Of Southwest Medical University

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary Intracranial aneurysm The presence or absence of IAs detected by digital subtractive angiography or by cranial computed tomography angiography / magnetic resonance angiography. 2010.01.01-2024.06.01
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