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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
Johns Hopkins University
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Coronary Arteriosclerosis focused on measuring MESA, MRI, Cardiovascular, Cardiac, Coronary, Atherosclerosis

Eligibility Criteria

45 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

First Posted
July 18, 2006
Last Updated
May 25, 2010
Sponsor
Johns Hopkins University
Collaborators
Northwestern University
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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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