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

This study is enrolling participants by invitation only.
Sponsor:
Information provided by:
Second Military Medical University
ClinicalTrials.gov Identifier:
NCT00997698
First received: October 18, 2009
Last updated: October 26, 2009
Last verified: October 2009

October 18, 2009
October 26, 2009
January 2009
December 2010   (final data collection date for primary outcome measure)
Intracranial aneurysms identified by CE-MRA [ Time Frame: 24 months ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT00997698 on ClinicalTrials.gov Archive Site
Statistical analysis of the prospective factors which contribute to the development of intracranial aneurysms [ Time Frame: 6 months after the study ] [ Designated as safety issue: Yes ]
Same as current
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Contrast-enhanced Magnetic Resonance Angiography Investigation of Intracranial Aneurysms and Prospective Study of Risk Factors
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.

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

Observational
Observational Model: Cohort
Time Perspective: Prospective
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Non-Probability Sample

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.

Intracranial Aneurysm
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Enrolling by invitation
4000
June 2011
December 2010   (final data collection date for primary outcome measure)

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
Both
20 Years to 80 Years
Yes
Contact information is only displayed when the study is recruiting subjects
China
 
NCT00997698
SecondMMU
Yes
Changhai Hospital affiliated to Second Military Medical University
Second Military Medical University
Not Provided
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
Second Military Medical University
October 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP