Epidemiology of Breast Arterial Calcification
Primary Purpose
Coronary Disease, Cardiovascular Diseases, Heart Diseases
Status
Completed
Phase
Locations
Study Type
Observational
Intervention
Sponsored by
About this trial
This is an observational trial for Coronary Disease
Eligibility Criteria
No eligibility criteria
Sites / Locations
Outcomes
Primary Outcome Measures
Secondary Outcome Measures
Full Information
NCT ID
NCT00091780
First Posted
September 16, 2004
Last Updated
February 19, 2014
Sponsor
Mayo Clinic
Collaborators
National Heart, Lung, and Blood Institute (NHLBI)
1. Study Identification
Unique Protocol Identification Number
NCT00091780
Brief Title
Epidemiology of Breast Arterial Calcification
Study Type
Observational
2. Study Status
Record Verification Date
February 2014
Overall Recruitment Status
Completed
Study Start Date
September 2004 (undefined)
Primary Completion Date
July 2007 (Actual)
Study Completion Date
July 2007 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Mayo Clinic
Collaborators
National Heart, Lung, and Blood Institute (NHLBI)
4. Oversight
5. Study Description
Brief Summary
To test the hypothesis that breast arterial calcification (BAC) seen on mammograms can identify women with an increased risk of coronary artery disease (CAD).
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Coronary Disease, Cardiovascular Diseases, Heart Diseases
7. Study Design
10. Eligibility
Sex
Female
Accepts Healthy Volunteers
No
Eligibility Criteria
No eligibility criteria
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dana Whaley
Organizational Affiliation
Mayo Clinic
12. IPD Sharing Statement
Learn more about this trial
Epidemiology of Breast Arterial Calcification
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