NCT05608122

Establishment of Online Registration Platform for Unruptured Intracranial Aneurysms Based on Regional Medical Centers in China and Population Follow-up Study (Phase Ⅱ)

Completed Last updated 3 April 2025

What this trial tests

trial testing Obervation in Intracranial Aneurysm in 3,740 participants. Completed in 10 November 2024.

Timeline

30 October 2022

Primary endpoint
10 November 2024

10 November 2024

Quick facts

Lead sponsor	Beijing Tiantan Hospital
Status	Completed
Study type	OBSERVATIONAL
Enrollment	3,740
Start date	30 October 2022
Primary completion	10 November 2024
Estimated completion	10 November 2024
Sites	1 location across China

Drugs / interventions tested

• Obervation
• Obervation

Conditions studied

• Intracranial Aneurysm — all drugs for Intracranial Aneurysm →

Sponsor

Beijing Tiantan Hospital

Who can join

Adults 18 to 75, any sex, with Intracranial Aneurysm. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Intracranial aneurysm is the main cause of subarachnoid hemorrhage, and the incidence of subarachnoid hemorrhage in Chinese population is about 5%. The intervention of unruptured intracranial aneurysms is controversial because of its great harm after natural rupture and bleeding, and about a quarter of patients still have poor prognosis through existing invasive treatment methods. How to accurately determine the instability risk of unruptured intracranial aneurysms is the key to resolve this controversy.

In previous studies, the stability of intracranial aneurysms involves many characteristics, and the sample size is small. Most of them are retrospective studies and studies on the status after change (rupture/growth). Therefore, the relevant risk factors are not clear at present, and there is still a lack of reliable prediction model. Based on the above facts, this study proposed based on the national hundred regional medical institutions set up the network registration platform of unruptured intracranial aneurysms, real time and openness of Internet, through the way of case resource sharing build unruptured intracranial aneurysm queue, collecting clinical characteristics, imaging features, hemodynamic detection of biological samples and the results of the analysis data, And observe them for two years. The artificial intelligence platform of Tonglian Medical Health was used to integrate and analyze and learn all the data, and then the risk factors related to the stability of intracranial aneurysms within two years were obtained, and the stability prediction model of unruptured intracranial aneurysms was constructed. This study will build the largest network registration platform and population follow-up cohort of unruptured intracranial aneurysms in China, and put forward a prediction model for the stability of unruptured intracranial aneurysms by integrating the multi-dimensional factors of intracranial aneurysms, so as to provide a powerful auxiliary judgment tool for the clinical decision-making of this disease.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

1. Artificial Intelligence in Neurosurgery: A State-of-the-Art Review from Past to Future.
   Tangsrivimol JA, Schonfeld E, Zhang M, Veeravagu A, et al · · 2023 · cited 43× · PMID 37510174 · DOI 10.3390/diagnostics13142429
2. A Decision Tree Model to Help Treatment Decision-Making for Unruptured Intracranial Aneurysms: A Multi-center, Long-Term Follow-up Study in a Large Chinese Cohort.
   Wen Z, Nie X, Chen L, Liu P, et al · · 2025 · cited 4× · PMID 39037513 · DOI 10.1007/s12975-024-01280-7