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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00997698
Recruitment Status : Unknown
Verified October 2009 by Second Military Medical University.
Recruitment status was:  Enrolling by invitation
First Posted : October 19, 2009
Last Update Posted : October 27, 2009
Information provided by:
Second Military Medical University

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.

Condition or disease
Intracranial Aneurysm

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

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Study Type : Observational
Estimated Enrollment : 4000 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Imaging Epidemiological Investigation of Intracranial Aneurysms and the Prospective Study of Risk Factors:Assessment of MR Imaging Trail
Study Start Date : January 2009
Estimated Primary Completion Date : December 2010
Estimated Study Completion Date : June 2011

Resource links provided by the National Library of Medicine

Primary Outcome Measures :
  1. Intracranial aneurysms identified by CE-MRA [ Time Frame: 24 months ]

Secondary Outcome Measures :
  1. Statistical analysis of the prospective factors which contribute to the development of intracranial aneurysms [ Time Frame: 6 months after the study ]

Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00997698

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China, Shanghai
Changhai Hospital, Second Military Medical University
Shanghai, Shanghai, China, 200433
Sponsors and Collaborators
Second Military Medical University
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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
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Responsible Party: Changhai Hospital affiliated to Second Military Medical University Identifier: NCT00997698    
Other Study ID Numbers: SecondMMU
First Posted: October 19, 2009    Key Record Dates
Last Update Posted: October 27, 2009
Last Verified: October 2009
Keywords provided by Second Military Medical University:
Intracranial aneurysm
Magnetic resonance angiography
Additional relevant MeSH terms:
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Intracranial Aneurysm
Vascular Diseases
Cardiovascular Diseases
Intracranial Arterial Diseases
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases