The Natural Course of Unruptured Intracranial Aneurysms in a Chinese Cohort

• Conditions: Aneurysm, Intracranial; Natural History

• Registration Number: NCT03117803
• Lead Sponsor: Tang-Du Hospital

Brief Summary

This is a registry study of the natural course of unruptured intracranial aneurysms (UIA). In addition, the investigators will analyze the risk factors for the rupture of the UIA and their joint effect. The investigators aim to use research data to create a China national database of UIA.

Detailed Description

This is a registry study of the natural course of unruptured intracranial aneurysms (UIA). In addition, the investigators will analyze the risk factors for the rupture of the UIA and their joint effect. The investigators aim to use research data to create a China national database of UIA.

This study is supported by a research grant from the Ministry of Science and Technology of the People's Republic of China. The investigators will collaborate with the other 19 medical centers which locate in the different districts of China. During the study period, all the patients included in this study will observe and treat in the collaborating medical centers. Included patients will be followed-up for at least 1year.

Research data will represent the real natural course of UIA in China.

For this study, the investigators consulted and hired professional experts about data collection, data and methodology. An intact systematic project steering committee, including Data Monitoring Committee, Data Management Committee, Project Academic Committee, Executive Group, Project Manager, Project Statistician, and Technical Support Center has been built up. Scientific regulations have also been made.

Study Timeline

• Status Verified: 2017-04
• Study First Submitted: 2017-04-04
• Study First Submitted QC: 2017-04-12
• Study First Posted: 2017-04-18
• Study Start: 2017-05-01
• Last Update Submitted: 2017-07-02
• Last Update Posted: 2017-07-05
• Primary Completion: 2020-12-30
• Study Completion: 2021-12-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 5000

Inclusion Criteria

1. Diagnosis of untreated unruptured intracranial aneurysm (by CTA, MRA or DSA)
2. Patient with premorbid mRS of 3 or less.
3. Patient older than 18 years
4. Patient consenting to participate to the study

Exclusion Criteria

1. Subarachnoid hemorrhage with unknown causes
2. Patient with other cerebral arteriovenous malformations or cerebral arteriovenous fistulas
3. Patient with malignant tumor
4. Target aneurysm is fusiform, traumatic, mycotic, or dissecting related.
5. Inability to obtain informed consent.
6. Patients with a life expectancy less than 1 year
7. Participating in the other clinical studies of intracranial aneurysm
8. Refusal of follow-up

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
aneurysm rupture rate	Up to 4 years or time of aneurysm repair surgery	aneurysm rupture rate

Secondary Outcome Measures

Name	Time	Method
Morphological changes of aneurysms	Up to 4 years or time of aneurysm repair surgery	maximum diameter increase ≥ 1mm or appearance of a daughter sac

Trial Locations

Locations (1)

Tandu Hospital, Fourth Military Medical University; 🇨🇳 Xi'an, Shaanxi, China