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NCT Number: NCT06456814

Epidemiological Insights Into the Formation, Progression, and Rupture of Intracranial 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.

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

Primary outcomes

  1. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Chuanzhi Duan, MD, PhD

CONTACT

[email protected]

15622311746

Sponsors and collaborators

Lead sponsor

Zhujiang Hospital

Other

Collaborators

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

Registry information

Official study title

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

Important dates

Study start
2010
Primary completion
2024
Study completion
2026
First posted
Jun 13, 2024
Registry last updated
Jun 13, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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