NCT00926172

Brief Summary

The Chinese Cerebral Aneurysms Survey is a continuing prospective study among middle-aged and older individuals (35 - 75 years) that aims to determine the prevalence of cerebral intracranial aneurysms in the general population with MRA at 3.0 Tesla (T).

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
4,500

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jun 2007

Typical duration 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

Study Start

First participant enrolled

June 1, 2007

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2008

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

June 19, 2009

Completed
4 days until next milestone

First Posted

Study publicly available on registry

June 23, 2009

Completed
11 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2010

Completed
Last Updated

December 14, 2009

Status Verified

December 1, 2009

Enrollment Period

1.5 years

First QC Date

June 19, 2009

Last Update Submit

December 11, 2009

Conditions

Keywords

Magnetic resonance angiographyIntracranial aneurysmcerebral aneurysmunruptured aneurysmEpidemiologyMagnetic Resonance Imaging

Outcome Measures

Primary Outcomes (1)

  • Cerebral intracranial aneurysms identified by 3-D TOF-MRA at 3T

    18 months after the study

Secondary Outcomes (1)

  • Suspected cerebral aneurysms detected by MRA underwent digital subtraction angiography (DSA) examination

    32-36 months

Eligibility Criteria

Age35 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

The investigators recruited 4500-5000 native inhabitants aged 35-75 years lived in China according to China census-tract data from the year 2005. The gender was accordance with China census-tract data, and the population aged 35-75 years has a higher incident of intracranial aneurysm in the literature. Assuming an 8 percent prevalence of intracranial aneurysm in the general population and using a two-sided alpha value of 0.05, the investigators estimated that 4500-5000 native inhabitants would need to be enrolled for the study.

You may qualify if:

  • Native inhabitants lived in a defined area sites in China
  • Aged 35-75 years

You may not qualify if:

  • Less than 35 years old or more than 75 years old
  • Incompetent patient who cannot give consent for routine MR Angiography and his/her surrogate decision maker is not available
  • Any patients with a contraindication to having a standard MRI examination, such as phase maker, orbital metallic foreign body, etc.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The Sixth Affiliated People's Hospital, Shanghai Jiao Tong University

Shanghai, Shanghai Municipality, 200233, China

RECRUITING

Related Publications (1)

  • Li MH, Cheng YS, Li YD, Fang C, Chen SW, Wang W, Hu DJ, Xu HW. Large-cohort comparison between three-dimensional time-of-flight magnetic resonance and rotational digital subtraction angiographies in intracranial aneurysm detection. Stroke. 2009 Sep;40(9):3127-9. doi: 10.1161/STROKEAHA.109.553800. Epub 2009 Jun 25.

MeSH Terms

Conditions

Intracranial Aneurysm

Condition Hierarchy (Ancestors)

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

Study Officials

  • Ming-Hua Li, MD, PhD

    The Sixth Affiliated People's Hospital, Shanghai Jiao Tong University

    STUDY CHAIR
  • Yong-Dong Li, MD, PhD

    The Sixth Affiliated People's Hospital, Shanghai Jiao Tong University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Yong-Dong Li, MD, PhD

CONTACT

Ming-Hua Li, MD, PhD

CONTACT

Study Design

Study Type
observational
Observational Model
ECOLOGIC OR COMMUNITY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER

Study Record Dates

First Submitted

June 19, 2009

First Posted

June 23, 2009

Study Start

June 1, 2007

Primary Completion

December 1, 2008

Study Completion

June 1, 2010

Last Updated

December 14, 2009

Record last verified: 2009-12

Locations