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

• Conditions: Intracranial Aneurysm

• Registration Number: NCT00997698
• Lead Sponsor: 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.

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 Timeline

• Study Start: 2009-01
• Status Verified: 2009-10
• Study First Submitted: 2009-10-18
• Study First Submitted QC: 2009-10-18
• Study First Posted: 2009-10-19
• Last Update Submitted: 2009-10-26
• Last Update Posted: 2009-10-27
• Primary Completion: 2010-12
• Study Completion: 2011-06

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 4000

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Intracranial aneurysms identified by CE-MRA	24 months

Secondary Outcome Measures

Name	Time	Method
Statistical analysis of the prospective factors which contribute to the development of intracranial aneurysms	6 months after the study

Trial Locations

Locations (1)

Changhai Hospital, Second Military Medical University; 🇨🇳 Shanghai, Shanghai, China