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Mammography and Breast Arterial Calcification: An Information-Sharing Trial

NCT04983875 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 5492

Last updated 2026-04-16

No results posted yet for this study

Summary

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.

Conditions

  • Mammography
  • Vascular Calcification

Interventions

BEHAVIORAL

BAC-Enhanced Letter

The BAC-Enhanced Letter intervention includes enhancing the standard mammography results letter with a few additional lines of text informing patients of their personal BAC status.

BEHAVIORAL

Waitlist Control

Patients randomized to this group will receive a standard post-mammography results letter which does not include any information about their personal BAC status. However, participants randomized to this group will be informed of their personal BAC findings at the end of their study participation (approximately 6 months after mammography).

Sponsors & Collaborators

Principal Investigators

  • Guy H. Montgomery, Ph.D. · Icahn School of Medicine at Mount Sinai

Study Design

Allocation
RANDOMIZED
Purpose
SCREENING
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
40 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-09-29
Primary Completion
2026-09-30
Completion
2027-03-31

Countries

  • United States

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04983875 on ClinicalTrials.gov