NCT00997698

Brief Summary

This is a prospective observational registry with intent to detect the prevalence of intracranial aneurysms with contrast-enhanced MR angiography (CE-MRA) at 1.5T, and to determine the risk factors such as high blood pressure and cigarette smoking relating to intracranial aneurysms.

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
4,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2009

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

January 1, 2009

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

October 18, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 19, 2009

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2010

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2011

Completed
Last Updated

October 27, 2009

Status Verified

October 1, 2009

Enrollment Period

1.9 years

First QC Date

October 18, 2009

Last Update Submit

October 26, 2009

Conditions

Intracranial Aneurysm

Keywords

Intracranial aneurysmMagnetic resonance angiographyEpidemiology

Outcome Measures

Primary Outcomes (1)

  • Intracranial aneurysms identified by CE-MRA

    24 months

Secondary Outcomes (1)

  • Statistical analysis of the prospective factors which contribute to the development of intracranial aneurysms

    6 months after the study

Eligibility Criteria

Age20 Years - 80 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

People coming to Changhai hospital to get health check or consult docter, undergoing cerebral CE-MRA, and according with the criteria were recruited. Assuming an 8 percent prevalence of intracranial aneurysm in the general population and using a two-sided alpha value of 0.05, we estimated that 4000 persons would need to be enrolled for the study.

You may qualify if:

  • Aged 20 to 80 years
  • Willing to undergo study procedures
  • Who are fully informed about the study and have signed the informed consent form

You may not qualify if:

  • History of intracranial aneurysm
  • History of intracranial tumor
  • History of cerebral infarction
  • Acute stroke
  • Require emergency treatment
  • Contraindication for MRI examination
  • Severely impaired renal functions
  • Known anaphylactic reaction to MR contrast media
  • Pregnancy or nursing

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Changhai Hospital, Second Military Medical University

Shanghai, Shanghai Municipality, 200433, China

Location

MeSH Terms

Conditions

Intracranial Aneurysm

Condition Hierarchy (Ancestors)

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

Study Officials

  • Ping J Lu, MD, PhD

    Changhai Hospital affiliated to Second Military Medical University

    STUDY DIRECTOR

  • Qi Liu, MD, PhD

    Changhai Hospital affiliated to Second Military Medical University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER

Study Record Dates

First Submitted

October 18, 2009

First Posted

October 19, 2009

Study Start

January 1, 2009

Primary Completion

December 1, 2010

Study Completion

June 1, 2011

Last Updated

October 27, 2009

Record last verified: 2009-10

Locations

CN(1)