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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


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
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