AzTrials
AzTrials

Cardiovascular DiseasesECACNCT00005349

Epidemiology of Coronary Artery Calcification

An observational study of Cardiovascular Diseases and Atherosclerosis, run by University of Michigan.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 20 to 91 yearsHealthy volunteers can take part
How many people
1,736 participants
Where
No sites listed yet
Study dates
Apr 1991to Feb 2008
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 20 to 91 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

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

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.

About this study

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.

Read the 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.

Medical subject headings
Cardiovascular Diseases, Atherosclerosis, Coronary Artery Disease, Heart Diseases, Coronary Disease

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Coronary Artery Calcification

    Measured: 1991-2005

Secondary outcomes (1)

  1. Coronary disease risk factors

    Measured: 1991-2005

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted26 May 2000 (estimated)
  2. Study startApr 1991
  3. Primary completionFeb 2008
  4. Study completionFeb 2008

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Ecologic or community
Time perspective
Cross-sectional
Enrolment
1,736 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00005349
Sponsor's protocol ID
4218
Other IDs
5R01HL046292-13
Acronym
ECAC
Status last verified
Jun 2013
First submitted
25 May 2000
Last updated
19 Jun 2013
Results posted
No

Publications

  • Bielak LF, Kaufmann RB, Moll PP, McCollough CH, Schwartz RS, Sheedy PF 2nd. Small lesions in the heart identified at electron beam CT: calcification or noise? Radiology. 1994 Sep;192(3):631-6. doi: 10.1148/radiology.192.3.8058926.

    PubMed 8058926

  • Blanco-Vaca F, Gaubatz JW, Bren N, Kottke BA, Morrisett JD, Guevara J Jr. Identification and quantification of apolipoproteins in addition to apo[a] and apo B-100 in human lipoprotein[a]. Chem Phys Lipids. 1994 Jan;67-68:35-42. doi: 10.1016/0009-3084(94)90122-8.

    PubMed 8187234

  • Rastogi A, Bren ND, Hallaway BJ, Kottke BA. Immunomagnetic separation of subpopulations of apolipoprotein A-I. Mayo Clin Proc. 1994 Feb;69(2):137-43. doi: 10.1016/s0025-6196(12)61040-4.

    PubMed 8309265

  • Kaufmann RB, Sheedy PF 2nd, Breen JF, Kelzenberg JR, Kruger BL, Schwartz RS, Moll PP. Detection of heart calcification with electron beam CT: interobserver and intraobserver reliability for scoring quantification. Radiology. 1994 Feb;190(2):347-52. doi: 10.1148/radiology.190.2.8284380.

    PubMed 8284380

  • Kanaley JA, Andresen-Reid ML, Oenning L, Kottke BA, Jensen MD. Differential health benefits of weight loss in upper-body and lower-body obese women. Am J Clin Nutr. 1993 Jan;57(1):20-6. doi: 10.1093/ajcn/57.1.20.

    PubMed 8416660

  • Peyser PA. Genetic epidemiology of coronary artery disease. Epidemiol Rev. 1997;19(1):80-90. doi: 10.1093/oxfordjournals.epirev.a017949. No abstract available.

    PubMed 9360905

  • Rumberger JA, Sheedy PF, Breen JF, Schwartz RS. Electron beam computed tomographic coronary calcium score cutpoints and severity of associated angiographic lumen stenosis. J Am Coll Cardiol. 1997 Jun;29(7):1542-8. doi: 10.1016/s0735-1097(97)00093-4.

    PubMed 9180117

  • Rumberger JA, Sheedy PF 2nd, Breen JF, Fitzpatrick LA, Schwartz RS. Electron beam computed tomography and coronary artery disease: scanning for coronary artery calcification. Mayo Clin Proc. 1996 Apr;71(4):369-77. doi: 10.4065/71.4.369.

    PubMed 8637260

  • Rumberger JA, Simons DB, Fitzpatrick LA, Sheedy PF, Schwartz RS. Coronary artery calcium area by electron-beam computed tomography and coronary atherosclerotic plaque area. A histopathologic correlative study. Circulation. 1995 Oct 15;92(8):2157-62. doi: 10.1161/01.cir.92.8.2157.

    PubMed 7554196

  • McCollough CH, Kaufmann RB, Cameron BM, Katz DJ, Sheedy PF 2nd, Peyser PA. Electron-beam CT: use of a calibration phantom to reduce variability in calcium quantitation. Radiology. 1995 Jul;196(1):159-65. doi: 10.1148/radiology.196.1.7784560.

    PubMed 7784560

  • Rumberger JA, Sheedy PF 3rd, Breen JF, Schwartz RS. Coronary calcium, as determined by electron beam computed tomography, and coronary disease on arteriogram. Effect of patient's sex on diagnosis. Circulation. 1995 Mar 1;91(5):1363-7. doi: 10.1161/01.cir.91.5.1363.

    PubMed 7867174

  • Kaufmann RB, Sheedy PF 2nd, Maher JE, Bielak LF, Breen JF, Schwartz RS, Peyser PA. Quantity of coronary artery calcium detected by electron beam computed tomography in asymptomatic subjects and angiographically studied patients. Mayo Clin Proc. 1995 Mar;70(3):223-32. doi: 10.4065/70.3.223.

    PubMed 7861809

  • Kaufmann RB, Peyser PA, Sheedy PF, Rumberger JA, Schwartz RS. Quantification of coronary artery calcium by electron beam computed tomography for determination of severity of angiographic coronary artery disease in younger patients. J Am Coll Cardiol. 1995 Mar 1;25(3):626-32. doi: 10.1016/0735-1097(94)00435-S.

    PubMed 7860906

  • Maher JE, Raz JA, Bielak LF, Sheedy PF 2nd, Schwartz RS, Peyser PA. Potential of quantity of coronary artery calcification to identify new risk factors for asymptomatic atherosclerosis. Am J Epidemiol. 1996 Nov 15;144(10):943-53. doi: 10.1093/oxfordjournals.aje.a008864.

    PubMed 8916505

  • Kardia SL, Haviland MB, Ferrell RE, Sing CF. The relationship between risk factor levels and presence of coronary artery calcification is dependent on apolipoprotein E genotype. Arterioscler Thromb Vasc Biol. 1999 Feb;19(2):427-35. doi: 10.1161/01.atv.19.2.427.

    PubMed 9974428

Questions about this trial

What is this clinical trial studying?

An observational study of Cardiovascular Diseases and Atherosclerosis, run by University of Michigan.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 19 Jun 2013. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Coronary Artery Calcification (time frame: 1991-2005). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00005349, which also lists 36 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Jun 2013.

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