Coronary Atherosclerosis Evaluation by Arterial Wall Magnetic Resonance Imaging (MRI)
Primary Purpose
Coronary Arteriosclerosis, Arteriosclerosis, Coronary, Atherosclerosis, Coronary
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
MR Imaging of the Coronary Arteries
Sponsored by
About this trial
This is an interventional diagnostic trial for Coronary Arteriosclerosis focused on measuring MESA, MRI, Cardiovascular, Cardiac, Coronary, Atherosclerosis
Eligibility Criteria
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
Sites / Locations
- Northwestern University MESA Field Center
- Johns Hopkins MESA Field Center
Outcomes
Primary Outcome Measures
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).
Secondary Outcome Measures
Full Information
NCT ID
NCT00353795
First Posted
July 18, 2006
Last Updated
May 25, 2010
Sponsor
Johns Hopkins University
Collaborators
Northwestern University
1. Study Identification
Unique Protocol Identification Number
NCT00353795
Brief Title
Coronary Atherosclerosis Evaluation by Arterial Wall Magnetic Resonance Imaging (MRI)
Official Title
Coronary Atherosclerosis Evaluation by Arterial Wall MRI
Study Type
Interventional
2. Study Status
Record Verification Date
September 2009
Overall Recruitment Status
Completed
Study Start Date
July 2005 (undefined)
Primary Completion Date
June 2008 (Actual)
Study Completion Date
June 2008 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Johns Hopkins University
Collaborators
Northwestern University
4. Oversight
5. Study Description
Brief 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.
Detailed 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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Coronary Arteriosclerosis, Arteriosclerosis, Coronary, Atherosclerosis, Coronary, Coronary Artery Disease, Coronary Atherosclerosis
Keywords
MESA, MRI, Cardiovascular, Cardiac, Coronary, Atherosclerosis
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
179 (Actual)
8. Arms, Groups, and Interventions
Intervention Type
Procedure
Intervention Name(s)
MR Imaging of the Coronary Arteries
Primary Outcome Measure Information:
Title
Mean Coronary Wall Thickness
Description
Average thickness of the wall of the left anterior descending, right and left main coronary artery measured by magnetic resonance imaging (MRI).
Time Frame
n/a (cross sectional analysis)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
David A Bluemke, MD PhD
Organizational Affiliation
Johns Hopkins University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Northwestern University MESA Field Center
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611
Country
United States
Facility Name
Johns Hopkins MESA Field Center
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21244
Country
United States
12. IPD Sharing Statement
Links:
URL
http://www.mesa-nhlbi.org/
Description
Multi-Ethnic Study of Atherosclerosis webpage
Learn more about this trial
Coronary Atherosclerosis Evaluation by Arterial Wall Magnetic Resonance Imaging (MRI)
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