Information-sharing about breast arterial calcification after mammography
Enhancing the Public Health Benefits of Mammography Screening by Informing Women of Both Breast Cancer and Breast Arterial Calcification Results: a Randomized Trial to Promote Cardiovascular Health
NA · Icahn School of Medicine at Mount Sinai · NCT04983875
This study is testing if giving women extra information about their breast arterial calcification results along with their mammogram results helps them understand their health better.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 14875 (estimated) |
| Ages | 40 Years and up |
| Sex | Female |
| Sponsor | Icahn School of Medicine at Mount Sinai (other) |
| Locations | 1 site (New York, New York) |
| Trial ID | NCT04983875 on ClinicalTrials.gov |
What this trial studies
This study aims to evaluate the benefits of providing women with information about their breast arterial calcification (BAC) results alongside standard mammography results. The research will involve a diverse group of 14,875 women scheduled for mammography at Mount Sinai's breast radiology clinics. Participants will receive either a BAC-enhanced letter or be placed in a waitlist control group to assess the impact of this additional information on patient awareness and health outcomes. The study seeks to address the gap in communication regarding BAC, which may be linked to coronary artery disease.
Who should consider this trial
Good fit: Ideal candidates are women aged 40 and older who are scheduled for mammography and can read and speak English or Spanish.
Not a fit: Patients with known coronary artery disease or significant cardiovascular conditions may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance patient awareness and potentially lead to better cardiovascular health outcomes for women.
How similar studies have performed: Previous studies have indicated a desire among patients for more information regarding BAC, suggesting potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
New York, New York
- Mount Sinai — New York, New York, United States (RECRUITING)
Study contacts
- Principal investigator: Guy H. Montgomery, Ph.D. — Icahn School of Medicine at Mount Sinai
- Study coordinator: Crystalinda Rapozo
- Email: crystalinda.rapozo@mssm.edu
- Phone: 212-659-5411
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Mammography, Vascular Calcification, Breast Arterial Calcification, Women's Health, Preventive Medicine, Behavioral Medicine, Screening