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Mammograms may reveal hidden heart risks – new study tests if telling women saves lives

NCT ID NCT04983875

Knowledge-focused Sponsor: Icahn School of Medicine at Mount Sinai Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study looks at whether telling women about breast artery calcification (BAC) found on mammograms can encourage them to see a heart doctor and adopt healthier habits. Over 5,400 women participated, with a smaller group randomly receiving a letter that included their BAC results. The goal is to see if this simple addition to standard mammography reports can improve cardiovascular health awareness and care.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
BAC-Enhanced Letter
What this could lead to
If successful, this could lead to routine inclusion of heart risk information in mammography results, helping women take early steps to protect their heart health.
What could go wrong
This is a small, early-stage study focused on behavior and awareness, not on direct health outcomes. The results may not change actual heart disease rates or apply to all populations.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

5,492 people

The number who actually took part.

Started

Sep 2021

Expected to finish

Mar 2027

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

40 years and older

Sex

Female participants only

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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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Conditions

The condition(s) this trial relates to.

calcinosis Vascular Calcification

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Mammography Vascular calcification

Contacts and locations

Locations

  • Mount Sinai

    New York, New York, 10029, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.