NCT03117803

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
5,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started May 2017

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 4, 2017

Completed
14 days until next milestone

First Posted

Study publicly available on registry

April 18, 2017

Completed
13 days until next milestone

Study Start

First participant enrolled

May 1, 2017

Completed
3.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 30, 2020

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2021

Completed
Last Updated

July 5, 2017

Status Verified

April 1, 2017

Enrollment Period

3.7 years

First QC Date

April 4, 2017

Last Update Submit

July 2, 2017

Conditions

Aneurysm, IntracranialNatural History

Keywords

Aneurysm, IntracranialRegistriesMulticenter StudiesPeople's Republic of China

Outcome Measures

Primary Outcomes (1)

  • aneurysm rupture rate

    aneurysm rupture rate

    Up to 4 years or time of aneurysm repair surgery

Secondary Outcomes (1)

  • Morphological changes of aneurysms

    Up to 4 years or time of aneurysm repair surgery

Eligibility Criteria

Age14 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

The patients who diagnosed as unruptured intracranial aneurysms

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Tandu Hospital, Fourth Military Medical University

Xi'an, Shaanxi, 710038, China

RECRUITING

Related Publications (4)

  • 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.

    PMID: 9867550BACKGROUND

  • 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.

    PMID: 12867109BACKGROUND

  • 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.

    PMID: 22738097BACKGROUND

  • 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.

    PMID: 31640726DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

whole blood

MeSH Terms

Conditions

Intracranial Aneurysm

Condition Hierarchy (Ancestors)

Intracranial Arterial DiseasesCerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesAneurysmVascular DiseasesCardiovascular Diseases

Study Officials

  • Yan Qu, M.D, Ph.D

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

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Wei Guo, M.D, Ph.D

CONTACT

86-1872998516818729985168@163.com

Haixiao Liu, M.D

CONTACT

86-1592931540756761311@qq.com

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
1 Year
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 4, 2017

First Posted

April 18, 2017

Study Start

May 1, 2017

Primary Completion

December 30, 2020

Study Completion

December 30, 2021

Last Updated

July 5, 2017

Record last verified: 2017-04

Data Sharing

IPD Sharing
Will share

share the original data 5 years after the study completion

Locations

CN(1)