Myocardial Perfusion, Risk Factors, and Coronary Calcium
Primary Purpose
Cardiovascular Diseases, Coronary Arteriosclerosis, Coronary Disease
Status
Completed
Phase
Locations
Study Type
Observational
Intervention
Sponsored by
About this trial
This is an observational trial for Cardiovascular Diseases
Eligibility Criteria
No eligibility criteria
Sites / Locations
Outcomes
Primary Outcome Measures
Secondary Outcome Measures
Full Information
NCT ID
NCT00006502
First Posted
November 16, 2000
Last Updated
February 26, 2016
Sponsor
National Heart, Lung, and Blood Institute (NHLBI)
1. Study Identification
Unique Protocol Identification Number
NCT00006502
Brief Title
Myocardial Perfusion, Risk Factors, and Coronary Calcium
Study Type
Observational
2. Study Status
Record Verification Date
July 2005
Overall Recruitment Status
Completed
Study Start Date
September 2000 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
June 2005 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
National Heart, Lung, and Blood Institute (NHLBI)
4. Oversight
5. Study Description
Brief Summary
To determine whether an impairment of myocardial perfusion reserve is an early indicator of coronary artery disease.
Detailed Description
BACKGROUND:
Impairment of coronary vasofunction is believed to be one of the earliest manifestations of coronary heart disease (CHD). The impact of risk factors such as elevated cholesterol levels, diabetes, hypertension, and smoking on the coronary microcirculation remains largely unknown.
DESIGN NARRATIVE:
The cross-sectional study will determine whether an impairment of the myocardial perfusion reserve provides a marker of coronary heart disease (CHD) by comparing it to other novel measures of subclinical vascular disease, and by testing its association with risk factors for CHD. The study is ancillary to the Multi-Ethnic Study of Atherosclerosis ("MESA"), which is an NHLBI funded, prospective observational study of the characteristics of subclinical cardiovascular disease, i.e. disease detected non-invasively before it has produced signs and symptoms. In MESA new measures of subclinical disease such as coronary artery calcium and impaired brachial artery reactivity are to be examined to investigate their relationships to well-established risk factors and clinical events. Myocardial perfusion reserve (MPR)is a useful measure of coronary vasofunction that should be included in an evaluation of new measures of subclinical disease. An impaired MPR appears to be a specific early indicator of the functional impairment of the microcirculation in patients with risk factors for coronary artery disease. Magnetic resonance imaging (MRI) will be used as an advanced, quantitative imaging modality to determine in short (20 minute) exams the myocardial perfusion reserve in a group of 400 MESA participants. The study tests the hypothesis that impaired myocardial perfusion reserve indicates the presence of subclinical coronary atherosclerosis and coronary microvascular disease.
The study completion date listed in this record was obtained from the "End Date" entered in the Protocol Registration and Results System (PRS) record.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cardiovascular Diseases, Coronary Arteriosclerosis, Coronary Disease, Heart Diseases
7. Study Design
10. Eligibility
Sex
All
Maximum Age & Unit of Time
100 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
No eligibility criteria
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michael Jerosch-Herold
Organizational Affiliation
University of Minnesota
12. IPD Sharing Statement
Citations:
PubMed Identifier
12033585
Citation
Jerosch-Herold M, Swingen C, Seethamraju RT. Myocardial blood flow quantification with MRI by model-independent deconvolution. Med Phys. 2002 May;29(5):886-97. doi: 10.1118/1.1473135.
Results Reference
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PubMed Identifier
14598902
Citation
Swingen C, Seethamraju RT, Jerosch-Herold M. An approach to the three-dimensional display of left ventricular function and viability using MRI. Int J Cardiovasc Imaging. 2003 Aug;19(4):325-36. doi: 10.1023/a:1025450211508.
Results Reference
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PubMed Identifier
14579397
Citation
Jerosch-Herold M, Hu X, Murthy NS, Rickers C, Stillman AE. Magnetic resonance imaging of myocardial contrast enhancement with MS-325 and its relation to myocardial blood flow and the perfusion reserve. J Magn Reson Imaging. 2003 Nov;18(5):544-54. doi: 10.1002/jmri.10384.
Results Reference
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PubMed Identifier
12720262
Citation
Swingen CM, Seethamraju RT, Jerosch-Herold M. Feedback-assisted three-dimensional reconstruction of the left ventricle with MRI. J Magn Reson Imaging. 2003 May;17(5):528-37. doi: 10.1002/jmri.10290.
Results Reference
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PubMed Identifier
15170782
Citation
Jerosch-Herold M, Seethamraju RT, Swingen CM, Wilke NM, Stillman AE. Analysis of myocardial perfusion MRI. J Magn Reson Imaging. 2004 Jun;19(6):758-70. doi: 10.1002/jmri.20065.
Results Reference
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Myocardial Perfusion, Risk Factors, and Coronary Calcium
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