The Natural Course of Unruptured Intracranial Aneurysms in a Chinese Cohort
NCT ID: NCT03117803
Last Updated: 2017-07-05
Study Results
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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UNKNOWN
5000 participants
OBSERVATIONAL
2017-05-01
2021-12-30
Brief Summary
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Detailed Description
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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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Study Design
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COHORT
PROSPECTIVE
Eligibility Criteria
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Inclusion Criteria
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
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
14 Years
ALL
No
Sponsors
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Xuanwu Hospital, Beijing
OTHER
Tang-Du Hospital
OTHER
Responsible Party
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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
Countries
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Central Contacts
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Facility Contacts
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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.
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.
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.
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.
Other Identifiers
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2016YFC1300801
Identifier Type: -
Identifier Source: org_study_id
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