Mammography and Breast Arterial Calcification: An Information-Sharing Trial

  • STATUS
    Recruiting
  • End date
    Mar 25, 2026
  • participants needed
    14875
  • sponsor
    Icahn School of Medicine at Mount Sinai
Updated on 4 October 2022

Summary

The purpose of this research study is to determine the potential benefits of adding information on patients' breast arterial calcification (BAC) results to the standard results letter women receive after mammography. In addition to looking for potential breast cancer, research shows that mammograms can also detect the presence of calcifications within the breast arteries. Those calcifications can be associated with coronary artery disease. Right now, women are not routinely told whether or not they have BAC; that is, it's not part of standard practice to communicate that information to patients. However, previous research has suggested that patients would like to be informed about their BAC status more often. In this study, the team has two goals. First, the team wants to measure the rates of BAC in a large, diverse group of 14,875 women. Because most of the past research on BAC has largely been focused on White mammography patients, the researchers feel it is important to see if the results are similar or different in a more racially and ethnically diverse sample.

Second, the study team wants to understand the effects of giving women information on their BAC results as part of their standard post-mammography letter. Specifically, the study team wants to see how sharing that information might affect women's healthcare choices and lifestyle. The research will include 1,888 women in this second part of the study, which will be the first in the literature to explore women's reactions to BAC information. If research shows that women find the information useful, BAC information may be given to women regularly in the future.

Details
Condition Mammography, Vascular Calcification
Treatment Waitlist Control, BAC-Enhanced Letter
Clinical Study IdentifierNCT04983875
SponsorIcahn School of Medicine at Mount Sinai
Last Modified on4 October 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

Female
Scheduled to undergo mammography at one of Mount Sinai's breast radiology clinics (e.g., Dubin Breast Center, Radiology Associates)
Age ≥ 40 years
Read and speak English or Spanish
Ability to understand and the willingness to sign a written informed consent
Willing to sign and date any applicable medical record release documents for the study

Exclusion Criteria

Participants with known coronary artery disease (via self-report)
Previous physician-diagnosed heart attack, stroke or TIA, heart failure, angina or taking nitroglycerin, or atrial fibrillation (via self-report or review of EMR)
Inability to understand and comply with the instructions of the study due to the presence of cognitive or psychiatric conditions (such as dementia, psychosis, or mania), compromising ability to provide informed consent and/or follow study procedures
Pregnant women
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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