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Status unknownNCT03117803Updated Jul 5, 2017

The Natural Course of Unruptured Intracranial Aneurysms in a Chinese Cohort

An observational study in Aneurysm, Intracranial and Natural History, sponsored by Tang-Du Hospital. Status unknown at 1 site in China. Open to participants aged 14 Years and older. Per ClinicalTrials.gov, last updated 2017-07-05.

Sponsored by Tang-Du Hospital · Observational

The sponsor has not verified this record recently (last verified Apr 2017), so the status shown — last known as Recruiting — may be out of date.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
5,000
Ages
14 Years and older
Sex
All
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Study 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.

Read the 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.

02

Conditions studied

  • Aneurysm, Intracranial
  • Natural History

Keywords

  • Aneurysm, Intracranial
  • Registries
  • Multicenter Studies
  • People's Republic of China
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In context

Intracranial Aneurysm

427 studies on the registry are indexed under Intracranial Aneurysm; 115 are open to participants now.

This study's planned enrollment of 5,000 is above the median of 200 across 198 observational studies indexed under Intracranial Aneurysm.

Browse Intracranial Aneurysm studies →

Lead sponsor

Tang-Du Hospital is the lead sponsor of 164 studies on the registry; 77 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
14 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

The patients who diagnosed as unruptured intracranial aneurysms

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

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
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Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
5,000 participants (estimated)
Target follow-up
1 Year
Patient registry
Yes
Biospecimen retention
Samples with dna
06

What researchers measure

Primary outcomes

  1. aneurysm rupture rate

    aneurysm rupture rate

    Time frame: Up to 4 years or time of aneurysm repair surgery

Secondary outcomes

  1. Morphological changes of aneurysms

    maximum diameter increase ≥ 1mm or appearance of a daughter sac

    Time frame: Up to 4 years or time of aneurysm repair surgery

07

Study locations

1 of 1 sites recruiting
  • Tandu Hospital, Fourth Military Medical University
    Xi'an, Shaanxi 710038, China
    • Wei Guo, M.D Ph.D · Contact · 18729985168@163.com · 86-18729985168
    • Haixiao Liu, M.D · Contact · 56761311@qq.com · 86-15929315407
    • Yan Qu, M.D, Ph.D · Principal investigator
    Recruiting
08

References and documents

Publications

  • 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. PubMed 9867550 ↗
  • 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. PubMed 12867109 ↗
  • 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. PubMed 22738097 ↗
  • 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. PubMed 31640726 ↗

Individual participant data

Plan to share: Yes — share the original data 5 years after the study completion

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 5, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT03117803
Lead sponsor
Tang-Du Hospital
Collaborators
Xuanwu Hospital, Beijing
Responsible party
Sponsor
First posted
Apr 18, 2017
Start date
May 1, 2017
Primary completion
Dec 30, 2020 (estimated)
Completion
Dec 30, 2021 (estimated)
Last update
Jul 5, 2017

Study contacts

Wei Guo, M.D, Ph.D
Contact
18729985168@163.com
86-18729985168
Haixiao Liu, M.D
Contact
56761311@qq.com
86-15929315407
Yan Qu, M.D, Ph.D
principal investigator · Department of Neurosurgery, Tangdu Hospital, Fourth Military Medical University Xi'an, China

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is status unknown, as verified in Apr 2017. You cannot join it, but the record below documents what was studied.

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