Mammography and Breast Arterial Calcification: An Information-Sharing Trial
Running, not enrolling · Not applicable
Conditions studied: Mammography, Vascular Calcification
In brief
The purpose of this research study was 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. Women are not currently routinely told whether or not they have BAC; that is, it's not part of standard national practice to communicate that information to patients. However, previous research has suggested that patients would like to be informed about the BAC status more often. In this study, the team had two goals. First, the team wanted to measure the rates of BAC in a large, representative sample of 5492 women. Second, the study team wanted to understand the effects of providing women with the BAC results as part of the standard post-mammography letter. Specifically, the study team wants to see how sharing BAC information might affect women's healthcare choices and lifestyle. The research includes 527 randomized women in this second part of the study, which is the first in the literature to explore women's reactions to the BAC results. If research shows that women find the information useful, BAC information may be given to women regularly in the future.
Key facts
- Study ID
- NCT04983875
- Run by
- Icahn School of Medicine at Mount Sinai
- People needed
- 5492
- Starts
- 2021-09-29
- Expected to finish
- 2027-03-31
- Last updated by the study team
- 2026-04-16
Who can join
Age: 40 and older. Sex: female. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
Where it is running
- Mount Sinai — New York, New York, United States
Full record on ClinicalTrials.gov
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