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Epidemiology of Breast Arterial Calcification

Primary Purpose

Coronary Disease, Cardiovascular Diseases, Heart Diseases

Status
Completed
Phase
Locations
Study Type
Observational
Intervention
Sponsored by
Mayo Clinic
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an observational trial for Coronary Disease

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)FemaleDoes not accept healthy volunteers

No eligibility criteria

Sites / Locations

    Outcomes

    Primary Outcome Measures

    Secondary Outcome Measures

    Full Information

    First Posted
    September 16, 2004
    Last Updated
    February 19, 2014
    Sponsor
    Mayo Clinic
    Collaborators
    National Heart, Lung, and Blood Institute (NHLBI)
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    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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