Contrast-enhanced Magnetic Resonance Angiography Investigation of Intracranial Aneurysms and Prospective Study of Risk Factors (EIIA)

October 26, 2009 updated by: Second Military Medical University

Imaging Epidemiological Investigation of Intracranial Aneurysms and the Prospective Study of Risk Factors：Assessment of MR Imaging Trail

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.

Study Overview

Status

Unknown

Conditions

Detailed Description

Intracranial aneurysms are common and have been reported increased incidence rate because of the widespread use of high-resolution imaging techniques. They are clinically important because of the life-threatening rupture and hemorrhage. Early detection and diagnosis is the key of treatment. Contrast-enhanced MR angiography (CE-MRA), as a simple, sensitivity and noninvasive method, is playing an important role in Vascular Imaging. CE-MRA has been an accuracy modality for intracranial aneurysm at most centers and proved the high sensitivity and accuracy comparing with DSA. Therefore, we use CE-MRA at 1.5T as a tool of epidemiological investigation of intracranial aneurysms.

In retrospective analysis, conventional risk factors for intracranial aneurysms include hypertension, hyperlipidemia, diabetes mellitus (DM), smoking history, and family history, etc. However, retrospective analysis probably gives an underestimation or overestimation of the actual results. Prospective analysis will get accurate data on the risk factors relating to intracranial aneurysms

Study Type

Observational

Enrollment (Anticipated)

4000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Shanghai
      • Shanghai, Shanghai, China, 200433
        • Changhai Hospital, Second Military Medical University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Non-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.

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Intracranial aneurysms identified by CE-MRA
Time Frame: 24 months
24 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Statistical analysis of the prospective factors which contribute to the development of intracranial aneurysms
Time Frame: 6 months after the study
6 months after the study

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Second Military Medical University

Investigators

  • Study Director: Ping J Lu, MD, PhD, Changhai Hospital affiliated to Second Military Medical University
  • Principal Investigator: Qi Liu, MD, PhD, Changhai Hospital affiliated to Second Military Medical University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2009

Primary Completion (Anticipated)

December 1, 2010

Study Completion (Anticipated)

June 1, 2011

Study Registration Dates

First Submitted

October 18, 2009

First Submitted That Met QC Criteria

October 18, 2009

First Posted (Estimate)

October 19, 2009

Study Record Updates

Last Update Posted (Estimate)

October 27, 2009

Last Update Submitted That Met QC Criteria

October 26, 2009

Last Verified

October 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SecondMMU

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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