Epidemiology of Breast Arterial Calcification

This study has been completed.
Sponsor:
Collaborator:
Information provided by:
Mayo Clinic
ClinicalTrials.gov Identifier:
NCT00091780
First received: September 16, 2004
Last updated: February 19, 2014
Last verified: February 2014
  Purpose

To test the hypothesis that breast arterial calcification (BAC) seen on mammograms can identify women with an increased risk of coronary artery disease (CAD).


Condition
Coronary Disease
Cardiovascular Diseases
Heart Diseases

Study Type: Observational

Resource links provided by NLM:


Further study details as provided by Mayo Clinic:

Study Start Date: September 2004
Study Completion Date: July 2007
Primary Completion Date: July 2007 (Final data collection date for primary outcome measure)
Detailed Description:

BACKGROUND:

The study hypothesis is that breast arterial calcification (BAC) seen on mammograms can identify women with an increased risk of coronary artery disease (CAD). Annual mammograms are now routinely obtained on nearly 70% of women over forty years of age. The nearly 40 million examinations performed every year could be used to evaluate for BAC without any additional cost or change in current mammographic techniques. Identification of women with BAC has potential to substantially decrease the rate of heart attack and sudden death due to CAD in asymptomatic women. Before BAC can be used in a clinical setting, the age-specific prevalence of BAC needs to be fully defined using state of the art mammographic techniques. BAC then needs to be compared with well understood CAD risk factors and measures of coronary atherosclerosis. While this could be accomplished in a prospective study, the same goals can be attained using data already acquired in the Epidemiology of Coronary Calcification (ECAC) Study.

The study uses existing data on 612 non-high risk, non-referred women who are participants in the community-based ECAC Study funded by NIH from 1991-2006. This database includes traditional and newer coronary artery disease (CAD) risk factors and the results of electron beam computed tomography (EBCT) examinations for CAC at a baseline examination. Most of the women also have had risk factors and CAC measured during a follow-up examination, on average, five years after baseline examinations. The women in the ECAC Study, who do not have a history of myocardial infarction (MI) or stroke, represent the full age range routinely evaluated with mammograms. Almost all these women have their usual care, including annual mammograms, in Rochester, Minnesota.

DESIGN NARRATIVE:

The ECAC study has been instrumental in establishing the distribution of presence and quantity of CAC as well as the predictors of CAC. The database includes clinical and laboratory assessments of CAD risk factors, results of EBCTs, and findings on physical examinations. It will ultimately include information on adverse clinical events. There are 612 female participants who had one or more mammograms during the 12-year history of that study. Many women had 10 or more mammograms. The study will evaluate all of these mammograms for BAC and compare the findings with information already in the database. The combination of newly acquired data from mammograms with the existing data allows this to be a very comprehensive study and still be completed in the two-year time period. The findings can then be used to help design a future study to prospectively evaluate the impact of instituting preventive and early therapeutic measures for CAD in asymptomatic women with the appropriate features of BAC on mammography.

  Eligibility

Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

No eligibility criteria

  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: NCT00091780

Sponsors and Collaborators
Mayo Clinic
Investigators
Investigator: Dana Whaley Mayo Clinic
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00091780     History of Changes
Other Study ID Numbers: 1271, R21HL077123
Study First Received: September 16, 2004
Last Updated: February 19, 2014
Health Authority: United States: Federal Government

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

ClinicalTrials.gov processed this record on July 31, 2014