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

NCT05608122 | Completed

• 1 other identifier: KY-2021-110-01
• Study Type: observational
• Target: 3,740
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Intracranial Aneurysm

Keywords

Intracranial Aneurysm; Artificial Intelligence

Outcome Measures

Primary Outcomes (1)

• Aneurysm rupture

  2 years

Secondary Outcomes (1)

• Aneurysm growth

  2 years

Study Arms (2)

unstable intracranial aneurysms

Unstable intracranial aneurysms are defined as the intracranial aneurysms that grows or ruptures.

Other: Obervation

stable intracranial aneurysms

Stable intracranial aneurysms are defined as the intracranial aneurysms that have no significant morphological changes.

Other: Obervation

Interventions

Obervation OTHER

This study is an observational study without any intervention

unstable intracranial aneurysms

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Chinese

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Beijing Tiantan Hospital: lead

Study Sites (1)

Beijing Tiantan Hospital

Beijing, Beijing Municipality, China

Location

MeSH Terms

Conditions

Intracranial Aneurysm

Condition Hierarchy (Ancestors)

Intracranial Arterial Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Aneurysm; Vascular Diseases; Cardiovascular Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 4 Years
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Department of neurosurgery

Study Record Dates

• First Submitted: November 1, 2022
• First Posted: November 8, 2022
• Study Start: October 30, 2022
• Primary Completion: November 10, 2024
• Study Completion: November 10, 2024
• Last Updated: April 3, 2025

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will share

Locations

CN (1)