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
  Purpose

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.


Condition
Cardiovascular Diseases
Atherosclerosis
Coronary Arteriosclerosis
Heart Diseases
Coronary Disease

Study Type: Observational
Study Design: Observational Model: Ecologic or Community
Time Perspective: Cross-Sectional

Resource links provided by NLM:


Further study details as provided by University of Michigan:

Primary Outcome Measures:
  • Coronary Artery Calcification [ Time Frame: 1991-2005 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Coronary disease risk factors [ Time Frame: 1991-2005 ] [ Designated as safety issue: No ]

Other Outcome Measures:
  • coronary artery disease risk factors [ Time Frame: 1991-2005 ] [ Designated as safety issue: No ]

Enrollment: 1736
Study Start Date: April 1991
Study Completion Date: February 2008
Primary Completion Date: February 2008 (Final data collection date for primary outcome measure)
Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   20 Years to 91 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

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

Criteria

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.

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00005349

Sponsors and Collaborators
University of Michigan
Investigators
Principal Investigator: Patricia A Peyser, PhD University of Michigan
  More Information

Publications:

Responsible Party: Patricia Peyser, Professor, University of Michigan
ClinicalTrials.gov Identifier: NCT00005349     History of Changes
Other Study ID Numbers: 4218, 5R01HL046292-13
Study First Received: May 25, 2000
Last Updated: June 18, 2013
Health Authority: United States: Federal Government

Additional relevant MeSH terms:
Arteriosclerosis
Atherosclerosis
Cardiovascular Diseases
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Heart Diseases
Arterial Occlusive Diseases
Vascular Diseases

ClinicalTrials.gov processed this record on August 19, 2014