Epidemiological Insights Into the Formation, Progression, and Rupture of Intracranial Aneurysms: A Retrospective, Multi-Center Hospital-Based Study in China

June 7, 2024 updated by: Duan Chuanzhi, Zhujiang Hospital

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.

Study Overview

Status

Recruiting

Conditions

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 Type

Observational

Enrollment (Estimated)

30000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

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.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
2010.01.01-2024.06.01

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Zhujiang Hospital

Collaborators

Beijing Tiantan Hospital
Guangdong Provincial People's Hospital
First Affiliated Hospital of Chongqing Medical University
The Affiliated Hospital Of Southwest Medical University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2010

Primary Completion (Actual)

June 1, 2024

Study Completion (Estimated)

December 31, 2026

Study Registration Dates

First Submitted

June 7, 2024

First Submitted That Met QC Criteria

June 7, 2024

First Posted (Actual)

June 13, 2024

Study Record Updates

Last Update Posted (Actual)

June 13, 2024

Last Update Submitted That Met QC Criteria

June 7, 2024

Last Verified

June 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NCT20240606IA

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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