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

• Sponsor: Johns Hopkins University (Other)
• Overall Status: Completed
• CT.gov ID: NCT00353795
• Collaborator: Northwestern University (Other)
• Enrollment: 179
• Locations: 2
• Duration (Months): 35
• Patients Per Site: 89.5
• Patients Per Site Per Month: 2.6

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Coronary Arteriosclerosis; Arteriosclerosis, Coronary; Atherosclerosis, Coronary; Coronary Artery Disease; Coronary Atherosclerosis	Procedure: MR Imaging of the Coronary Arteries	N/A

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

Study Design

• Study Type: Interventional
• Actual Enrollment: 179 participants
• Allocation: Randomized
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Diagnostic
• Official Title: Coronary Atherosclerosis Evaluation by Arterial Wall MRI
• Study Start Date: Jul 1, 2005
• Actual Primary Completion Date: Jun 1, 2008
• Actual Study Completion Date: Jun 1, 2008

Outcome Measures

Primary Outcome Measures

1. Mean Coronary Wall Thickness [n/a (cross sectional analysis)]

   Average thickness of the wall of the left anterior descending, right and left main coronary artery measured by magnetic resonance imaging (MRI).

Eligibility Criteria

Criteria

• Ages Eligible for Study: 45 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Northwestern University MESA Field Center	Chicago	Illinois	United States	60611
2	Johns Hopkins MESA Field Center	Baltimore	Maryland	United States	21244

Sponsors and Collaborators

• Johns Hopkins University
• Northwestern University

Investigators

• Principal Investigator: David A Bluemke, MD PhD, Johns Hopkins University

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

• Multi-Ethnic Study of Atherosclerosis webpage

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT00353795
• Other Study ID Numbers: 05-05-23-01; 5R01HL078909
• First Posted: Jul 19, 2006
• Last Update Posted: Jun 22, 2010
• Last Verified: Sep 1, 2009

• Keywords provided by , ,: MESA; MRI; Cardiovascular; Cardiac; Coronary; Atherosclerosis
• Additional relevant MeSH terms: Coronary Artery Disease; Myocardial Ischemia; Atherosclerosis; Arteriosclerosis

Study Results

Participant Flow

Arm/Group Title	Participants
Arm/Group Description	Participants in the MESA trial (http://www.mesa-nhlbi.org/) randomly selected by the University of Washington Coordinating center who agreed to participate. Enrollment from October 2005 to February 2008
Period Title: Overall Study
STARTED	179
COMPLETED	179
NOT COMPLETED	0

Baseline Characteristics

Arm/Group Title	Participants
Arm/Group Description	Participants in the MESA trial (http://www.mesa-nhlbi.org/) randomly selected by the University of Washington Coordinating center who agreed to participate. Enrollment from October 2005 to February 2008
Overall Participants	179
Age (Count of Participants)
<=18 years	0 0%
Between 18 and 65 years	179 100%
>=65 years	0 0%
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	61 (9)
Sex: Female, Male (Count of Participants)
Female	90 50.3%
Male	89 49.7%
Region of Enrollment (participants) [Number]
United States	179 100%

Outcome Measures

1. Primary Outcome

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)

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Participants
Arm/Group Description	Participants in the MESA trial (http://www.mesa-nhlbi.org/) randomly selected by the University of Washington Coordinating center who agreed to participate. Enrollment from October 2005 to February 2008
Measure Participants	179
Mean (Standard Deviation) [mm]	2.0 (0.3)

Adverse Events

Arm/Group Title	Participants
Arm/Group Description	Participants in the MESA trial (http://www.mesa-nhlbi.org/) randomly selected by the University of Washington Coordinating center who agreed to participate. Enrollment from October 2005 to February 2008
All Cause Mortality
	Participants
	Affected / at Risk (%)	# Events
Total	/ (NaN)
Serious Adverse Events
	Participants
	Affected / at Risk (%)	# Events
Total	0/179 (0%)
Other (Not Including Serious) Adverse Events
	Participants
	Affected / at Risk (%)	# Events
Total	0/179 (0%)

Limitations/Caveats

Cross sectional study

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.