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

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.

Study Overview

• Status: Completed
• Conditions: Intracranial Aneurysm
• Intervention / Treatment: Other: Obervation

• Study Type: Observational
• Enrollment (Actual): 3740

Contacts and Locations

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China
      • Beijing Tiantan Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 71 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Chinese

Description

Inclusion Criteria:

1. 18-75 years old;
2. At least one unruptured intracranial aneurysm was found by CTA;
3. No relevant symptoms, receiving non-operative and conservative observation treatment;
4. Signing the informed consent.

Exclusion Criteria:

1. Other cerebrovascular structural lesions (such as cerebrovascular malformation and arteriovenous fistula) or craniocerebral tumors;
2. Fusiform or dissecting aneurysms;
3. Traumatic, mycotic and atrial myxoma associated aneurysms;
4. Suffering from systemic connective tissue diseases, such as polycystic kidney disease;
5. Expectant survival of no more than 3 years due to other diseases or poor general conditions;
6. Patients refuse to follow up or cannot communicate with them due to mental diseases;
7. Pregnant women or participating in other aneurysm related studies.

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
unstable intracranial aneurysms; Unstable intracranial aneurysms are defined as the intracranial aneurysms that grows or ruptures.	Other: Obervation; This study is an observational study without any intervention
stable intracranial aneurysms; Stable intracranial aneurysms are defined as the intracranial aneurysms that have no significant morphological changes.	Other: Obervation; This study is an observational study without any intervention

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Aneurysm rupture	2 years

Secondary Outcome Measures

Outcome Measure	Time Frame
Aneurysm growth	2 years

Collaborators and Investigators

• Sponsor: Beijing Tiantan Hospital

Study record dates

Study Major Dates

• Study Start (Actual): October 30, 2022
• Primary Completion (Actual): November 10, 2024
• Study Completion (Actual): November 10, 2024

Study Registration Dates

• First Submitted: November 1, 2022
• First Submitted That Met QC Criteria: November 1, 2022
• First Posted (Actual): November 8, 2022

Study Record Updates

• Last Update Posted (Actual): April 3, 2025
• Last Update Submitted That Met QC Criteria: March 30, 2025
• Last Verified: November 1, 2024

More Information

Terms related to this study

• Keywords: Artificial Intelligence; Intracranial Aneurysm
• Additional Relevant MeSH Terms: Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Intracranial Arterial Diseases; Aneurysm; Intracranial Aneurysm
• Other Study ID Numbers: KY-2021-110-01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No