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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
History of Changes
  Purpose

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
Intracranial Aneurysm

Study Type: Observational
Study Design: 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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Second Military Medical University:

Primary Outcome Measures:
  • Intracranial aneurysms identified by CE-MRA [ Time Frame: 24 months ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 4000
Study Start Date: January 2009
Estimated Study Completion Date: June 2011
Estimated Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)
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

  Eligibility

Ages Eligible for Study:   20 Years to 80 Years
Genders Eligible for Study:   Both
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.

Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00997698

Locations
China, Shanghai
Changhai Hospital, Second Military Medical University
Shanghai, Shanghai, China, 200433
Sponsors and Collaborators
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
  More Information

No publications provided

Responsible Party: Changhai Hospital affiliated to Second Military Medical University
ClinicalTrials.gov Identifier: NCT00997698     History of Changes
Other Study ID Numbers: SecondMMU
Study First Received: October 18, 2009
Last Updated: October 26, 2009
Health Authority: China: National Natural Science Foundation

Keywords provided by Second Military Medical University:
Intracranial aneurysm
Magnetic resonance angiography
Epidemiology

Additional relevant MeSH terms:
Aneurysm
Intracranial Aneurysm
Vascular Diseases
Cardiovascular Diseases
Intracranial Arterial Diseases
 Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases

ClinicalTrials.gov processed this record on May 16, 2013