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

This study has been completed.
Sponsor:
Collaborator:
Northwestern University
Information provided by:
Johns Hopkins University
ClinicalTrials.gov Identifier:
NCT00353795
First received: July 18, 2006
Last updated: May 25, 2010
Last verified: September 2009
History of Changes
Results First Received: August 4, 2009  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Diagnostic
Conditions: Coronary Arteriosclerosis
Arteriosclerosis, Coronary
Atherosclerosis, Coronary
Coronary Artery Disease
Coronary Atherosclerosis
Intervention: Procedure: MR Imaging of the Coronary Arteries

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
Participants 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

Participant Flow:   Overall Study
    Participants  
STARTED     179  
COMPLETED     179  
NOT COMPLETED     0  



  Baseline Characteristics
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Reporting Groups
  Description
Participants 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

Baseline Measures
    Participants  
Number of Participants  
[units: participants]
 		  179  
Age  
[units: participants]
 		 
<=18 years     0  
Between 18 and 65 years     179  
>=65 years     0  
Age  
[units: years]
Mean ± Standard Deviation 		  61  ± 9  
Gender  
[units: participants]
 		 
Female     90  
Male     89  
Region of Enrollment  
[units: participants]
 		 
United States     179  



  Outcome Measures

1.  Primary:   Mean Coronary Wall Thickness   [ Time Frame: n/a (cross sectional analysis) ]
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  Serious Adverse Events
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Additional Description No text entered.

Reporting Groups
  Description
Participants 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

Serious Adverse Events
    Participants  
Total, serious adverse events    
# participants affected / at risk     0/179 (0.00%)  




  Other Adverse Events
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  More Information
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Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Limitations and Caveats
Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
Cross sectional study  


Results Point of Contact:  
Name/Title: David Bluemke
Organization: NIH
phone: 301 402 1854
e-mail: bluemked@nih.gov


No publications provided


ClinicalTrials.gov Identifier: NCT00353795     History of Changes
Other Study ID Numbers: 05-05-23-01, 5R01HL078909
Study First Received: July 18, 2006
Results First Received: August 4, 2009
Last Updated: May 25, 2010
Health Authority: United States: Institutional Review Board