Epidemiology of Coronary Artery Calcification (ECAC)

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Patricia Peyser, University of Michigan
ClinicalTrials.gov Identifier:
NCT00005349
First received: May 25, 2000
Last updated: June 18, 2013
Last verified: June 2013

May 25, 2000
June 18, 2013
April 1991
February 2008   (final data collection date for primary outcome measure)
Coronary Artery Calcification [ Time Frame: 1991-2005 ] [ Designated as safety issue: No ]
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Complete list of historical versions of study NCT00005349 on ClinicalTrials.gov Archive Site
Coronary disease risk factors [ Time Frame: 1991-2005 ] [ Designated as safety issue: No ]
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coronary artery disease risk factors [ Time Frame: 1991-2005 ] [ Designated as safety issue: No ]
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Epidemiology of Coronary Artery Calcification
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Using subjects from the Rochester Family Heart Study (RFHS), to characterize predictors of coronary artery calcification (CAC), a potent marker of atherosclerosis, among individuals from the general population.

BACKGROUND:

Coronary artery disease (CAD) is a major cause of mortality and morbidity in the United States. Current noninvasive methods to identify individuals with atherosclerosis, such as exercise testing, are often insensitive until plaques have progressed enough to significantly impede blood flow or impair myocardial function. A large number of individuals destined to die suddenly or to experience myocardial infarction will experience no warning symptoms, having only mild non-flow limiting lesions which rupture and cause occlusive clot. Since coronary artery calcification (CAC) can identify individuals with mild, non-flow limiting lesions, CAC is a potent marker of atherosclerosis. The presence of calcium in mild, non-flow limiting lesions is hypothesized to be a predictor of coronary events in asymptomatic adults. Ultrafast Cardiac Computed Tomography (Ultrafast CT) provides a tool to obtain sensitive, noninvasive measures of both the presence and quantity of CAC.

DESIGN NARRATIVE:

Beginning in 1991, the study sought to establish if age and gender predict coronary artery calcification, a potent marker of atherosclerosis, in individuals who were sampled by the RFHS and who reported no symptoms of coronary artery disease. The study also sought to establish: if measures of lipid metabolism provide additional information in predicting CAC after accounting for variation in age and gender; if measures of blood pressure, body size, fat distribution, or smoking predict CAC after accounting for variation in age, gender, and measures of lipid metabolism; if the quantity of CAC aggregates in families; whether the predictors of CAC in asymptomatic individuals differ from predictors in those with symptoms of coronary artery disease. Ultrafast Cardiac Computed Tomography (Ultrafast CT) was used to obtain sensitive, noninvasive measures of both the presence and quantity of CAC.

The study was renewed in 2001 through February 2005 to: determine whether CAC predicts clinical events after 7.5 years of active followup; identify genetic determinants of change in CAC quantity; assess whether these genes act through measurable coronary artery disease risk factors. The full sample of 1,647 asymptomatic at baseline adults will be followed prospectively for clinical endpoints, while CAC quantity will be re-evaluated in a sub sample of 1,000 individuals.

The influence of newer inflammatory markers such as fibrinogen, C-reactive protein and antibodies to infective agents will be evaluated.

Observational
Observational Model: Ecologic or Community
Time Perspective: Cross-Sectional
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Non-Probability Sample

817 men and 830 women ages 20 and older recruited from Rochester, MN.

  • Cardiovascular Diseases
  • Atherosclerosis
  • Coronary Arteriosclerosis
  • Heart Diseases
  • Coronary Disease
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
1736
February 2008
February 2008   (final data collection date for primary outcome measure)

Individuals were recruited to participate if they had participated in the Rochester Family Heart Study or were siblings of those already in the ECAC study or had been in the GENOA Study or were identified to be at higher risk for having CAC. Potential participants were eligible if they were not pregnant, not lactating, and had never had coronary or non-coronary heart surgery. Eligibility for inclusion was independent of race, ethnicity, and country of birth.

Both
20 Years to 91 Years
Yes
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT00005349
4218, 5R01HL046292-13
Not Provided
Patricia Peyser, University of Michigan
University of Michigan
National Heart, Lung, and Blood Institute (NHLBI)
Principal Investigator: Patricia A Peyser, PhD University of Michigan
University of Michigan
June 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP