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

NCT ID: NCT00997698

Last Updated: 2009-10-27

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 4000 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2009-01-31
• Study Completion Date: 2011-06-30

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.

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

Conditions

Intracranial Aneurysm

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Eligibility 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

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Second Military Medical University

OTHER

Sponsor Role: lead

Responsible Party

Changhai Hospital affiliated to Second Military Medical University

Principal Investigators

Ping J Lu, MD, PhD

Role: STUDY_DIRECTOR

Changhai Hospital affiliated to Second Military Medical University

Qi Liu, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Changhai Hospital affiliated to Second Military Medical University

Locations

Changhai Hospital, Second Military Medical University

Shanghai, Shanghai Municipality, China

Countries

China

Other Identifiers

SecondMMU

Identifier Type: -

Identifier Source: org_study_id