Coronary Atherosclerosis Evaluation by Arterial Wall Magnetic Resonance Imaging (MRI)

Coronary Artery Disease Clinical Trial

Official title:

Coronary Atherosclerosis Evaluation by Arterial Wall MRI

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00353795
• Other study ID #: 05-05-23-01
• Secondary ID: 5R01HL078909
• Status: Completed
• Phase: N/A
• First received: July 18, 2006
• Last updated: May 25, 2010
• Start date: July 2005
• Est. completion date: June 2008

Study information

• Verified date: September 2009
• Source: Johns Hopkins University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

The overall goal of this study is to use MRI to:

• Examine the relationship between known risk factors for cardiovascular disease and coronary artery wall thickness;

• Examine the relationship between coronary artery wall thickness and other markers of subclinical coronary atherosclerosis, such as carotid wall thickness and coronary calcium scores; and,

• Examine the feasibility of measuring the progression of coronary artery wall thickness over time in a subset of participants.

Description:

Each enrolled participant will undergo MR Imaging of the coronary arteries in conjunction with their routine MESA follow-up visit. The MRI will last approximately 45-60 minutes

Recruitment information / eligibility

• Status: Completed
• Enrollment: 179
• Est. completion date: June 2008
• Est. primary completion date: June 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 45 Years and older

Eligibility

Inclusion Criteria:

• Prior enrollment in the MESA Study at the Hopkins MESA Field Center or the Northwestern University MESA Field Center

• Male or Female adult equal to or older than 45 years of age

• Willing/able to provide informed consent

Exclusion Criteria:

• Any known contraindications to MRI (i.e. severe claustrophobia, pacemaker, etc.)

• Metal in the eyes

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Arteriosclerosis
• Arteriosclerosis, Coronary
• Atherosclerosis
• Atherosclerosis, Coronary
• Coronary Arteriosclerosis
• Coronary Artery Disease
• Coronary Atherosclerosis
• Coronary Disease
• Myocardial Ischemia

Intervention

Procedure:
• MR Imaging of the Coronary Arteries

Locations

Country	Name	City	State
United States	Johns Hopkins MESA Field Center	Baltimore	Maryland
United States	Northwestern University MESA Field Center	Chicago	Illinois

Sponsors (2)

Lead Sponsor	Collaborator
Johns Hopkins University	Northwestern University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mean Coronary Wall Thickness	Average thickness of the wall of the left anterior descending, right and left main coronary artery measured by magnetic resonance imaging (MRI).	n/a (cross sectional analysis)	No

External Links

•   Multi-Ethnic Study of Atherosclerosis webpage