- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT03117803
The Natural Course of Unruptured Intracranial Aneurysms in a Chinese Cohort
Studieoversigt
Status
Betingelser
Detaljeret beskrivelse
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.
Undersøgelsestype
Tilmelding (Forventet)
Kontakter og lokationer
Studiekontakt
- Navn: Wei Guo, M.D, Ph.D
- Telefonnummer: 86-18729985168
- E-mail: 18729985168@163.com
Undersøgelse Kontakt Backup
- Navn: Haixiao Liu, M.D
- Telefonnummer: 86-15929315407
- E-mail: 56761311@qq.com
Studiesteder
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Shaanxi
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Xi'an, Shaanxi, Kina, 710038
- Rekruttering
- Tandu Hospital, Fourth Military Medical University
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Kontakt:
- Haixiao Liu, M.D
- Telefonnummer: 86-15929315407
- E-mail: 56761311@qq.com
-
Kontakt:
- Wei Guo, M.D Ph.D
- Telefonnummer: 86-18729985168
- E-mail: 18729985168@163.com
-
Ledende efterforsker:
- Yan Qu, M.D, Ph.D
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Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Prøveudtagningsmetode
Studiebefolkning
Beskrivelse
Inclusion Criteria:
- Diagnosis of untreated unruptured intracranial aneurysm (by CTA, MRA or DSA)
- Patient with premorbid mRS of 3 or less.
- Patient older than 18 years
- Patient consenting to participate to the study
Exclusion Criteria:
- Subarachnoid hemorrhage with unknown causes
- Patient with other cerebral arteriovenous malformations or cerebral arteriovenous fistulas
- Patient with malignant tumor
- Target aneurysm is fusiform, traumatic, mycotic, or dissecting related.
- Inability to obtain informed consent.
- Patients with a life expectancy less than 1 year
- Participating in the other clinical studies of intracranial aneurysm
- Refusal of follow-up
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
aneurysm rupture rate
Tidsramme: Up to 4 years or time of aneurysm repair surgery
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aneurysm rupture rate
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Up to 4 years or time of aneurysm repair surgery
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Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
Morfologiske ændringer af aneurismer
Tidsramme: Op til 4 år eller tidspunkt for aneurismereparationsoperation
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maksimal diameterforøgelse ≥ 1 mm eller udseende af en dattersæk
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Op til 4 år eller tidspunkt for aneurismereparationsoperation
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Samarbejdspartnere og efterforskere
Sponsor
Samarbejdspartnere
Efterforskere
- Ledende efterforsker: Yan Qu, M.D, Ph.D, Department of Neurosurgery, Tangdu Hospital, Fourth Military Medical University Xi'an, China
Publikationer og nyttige links
Generelle publikationer
- 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.
- 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. Erratum In: N Engl J Med 1999 Mar 4;340(9):744.
- 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.
Datoer for undersøgelser
Studer store datoer
Studiestart (Faktiske)
Primær færdiggørelse (Forventet)
Studieafslutning (Forventet)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Faktiske)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- 2016YFC1300801
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
IPD-planbeskrivelse
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
Studerer et amerikansk FDA-reguleret lægemiddelprodukt
Studerer et amerikansk FDA-reguleret enhedsprodukt
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Kliniske forsøg med Aneurisme, intrakraniel
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