The Natural Course of Unruptured Intracranial Aneurysms in a Chinese Cohort

NCT ID: NCT03117803

Last Updated: 2017-07-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

5000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-05-01

Study Completion Date

2021-12-30

Brief Summary

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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

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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.

Conditions

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Aneurysm, Intracranial Natural History

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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
Minimum Eligible Age

14 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Xuanwu Hospital, Beijing

OTHER

Sponsor Role collaborator

Tang-Du Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Yan Qu, M.D, Ph.D

Role: PRINCIPAL_INVESTIGATOR

Department of Neurosurgery, Tangdu Hospital, Fourth Military Medical University Xi'an, China

Locations

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Tandu Hospital, Fourth Military Medical University

Xi'an, Shaanxi, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Wei Guo, M.D, Ph.D

Role: CONTACT

86-18729985168

Haixiao Liu, M.D

Role: CONTACT

86-15929315407

Facility Contacts

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Wei Guo, M.D Ph.D

Role: primary

86-18729985168

Haixiao Liu, M.D

Role: backup

86-15929315407

References

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International Study of Unruptured Intracranial Aneurysms Investigators. Unruptured intracranial aneurysms--risk of rupture and risks of surgical intervention. N Engl J Med. 1998 Dec 10;339(24):1725-33. doi: 10.1056/NEJM199812103392401.

Reference Type BACKGROUND
PMID: 9867550 (View on PubMed)

Wiebers DO, Whisnant JP, Huston J 3rd, Meissner I, Brown RD Jr, Piepgras DG, Forbes GS, Thielen K, Nichols D, O'Fallon WM, Peacock J, Jaeger L, Kassell NF, Kongable-Beckman GL, Torner JC; International Study of Unruptured Intracranial Aneurysms Investigators. Unruptured intracranial aneurysms: natural history, clinical outcome, and risks of surgical and endovascular treatment. Lancet. 2003 Jul 12;362(9378):103-10. doi: 10.1016/s0140-6736(03)13860-3.

Reference Type BACKGROUND
PMID: 12867109 (View on PubMed)

UCAS Japan Investigators; Morita A, Kirino T, Hashi K, Aoki N, Fukuhara S, Hashimoto N, Nakayama T, Sakai M, Teramoto A, Tominari S, Yoshimoto T. The natural course of unruptured cerebral aneurysms in a Japanese cohort. N Engl J Med. 2012 Jun 28;366(26):2474-82. doi: 10.1056/NEJMoa1113260.

Reference Type BACKGROUND
PMID: 22738097 (View on PubMed)

Liu H, Guo W, Xiang S, Hu P, Sun F, Gao J, Zhang X, Wang P, Jing W, Zhang L, Yang X, Duan C, He M, Zhang H, Qu Y. The natural course of unruptured intracranial aneurysms in a Chinese cohort: protocol of a multi-center registration study in CIAP. J Transl Med. 2019 Oct 22;17(1):349. doi: 10.1186/s12967-019-2092-z.

Reference Type DERIVED
PMID: 31640726 (View on PubMed)

Other Identifiers

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2016YFC1300801

Identifier Type: -

Identifier Source: org_study_id

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