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

Intracranial Aneurysm Clinical Trial

— EIIA  

Official title:

Imaging Epidemiological Investigation of Intracranial Aneurysms and the Prospective Study of Risk Factors：Assessment of MR Imaging Trail

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT00997698
• Other study ID #: SecondMMU
• Status: Enrolling by invitation
• Phase: N/A
• First received: October 18, 2009
• Last updated: October 26, 2009
• Start date: January 2009
• Est. completion date: June 2011

Study information

• Verified date: October 2009
• Source: Second Military Medical University
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: National Natural Science Foundation
• Study type: Observational

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 4000
• Est. completion date: June 2011
• Est. primary completion date: December 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 20 Years to 80 Years

Eligibility

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

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Aneurysm
• Intracranial Aneurysm

Locations

Country	Name	City	State
China	Changhai Hospital, Second Military Medical University	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Second Military Medical University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Intracranial aneurysms identified by CE-MRA		24 months	Yes
Secondary	Statistical analysis of the prospective factors which contribute to the development of intracranial aneurysms		6 months after the study	Yes