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NCT Number: NCT07809932

Breast Artery Calcification (BAC) and Female Cardiovascular Disease

The investigators are recruiting women with and without Breast Artery Calcification (BAC) on their mammograms. Each participant in the study will undergo bloodwork at a Northwell Health lab, a cardiac CT scan, and fill out some brief questionnaires. Results will be shared with the respective participant. At the conclusion of the study, statistical analyses will be performed to further understand the associations between BAC and cardiovascular markers.

Recruiting

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Key information

Age range

55 year–65 year

Sex eligibility

Female

Study type

Observational

Primary location

North Shore University Hospital

Manhasset, New York, 11030, United States

Location status: Recruiting

About this study

Previous work has demonstrated an association between incidentally found BAC on screening mammograms and long-term major adverse cardiovascular events. However, there are no guidelines for how to manage asymptomatic women with no history of cardiovascular disease who have incidentally found BAC on a screening mammogram. This study will simulate a reasonable approach that a cardiologist might take in determining how to manage such patients. The study is unique compared with prior studies that have utilized a convenience sample, the investigators seek to gather this information in two parallel cohorts prospectively.

The investigators seek to recruit 100 women with BAC = 0 and 100 women with BAC >0 on their mammograms. The inclusion and exclusion criteria for these groups is otherwise identical. All women have had a recent mammogram and are 55-65 years old. Exclusion criteria include: ischemia, diabetes, statin/cholesterol lowering medication use, cardiovascular disease, breast cancer, breast surgery, current pregnancy/breastfeeding, and women unable to consent.

Participants will be recruited over the phone and able to e-consent if interested in the study. All participants will fill out 2 questionnaires: one on their baseline demographics/clinical history, and one on social factors. Patients will then be scheduled for bloodwork at a Northwell lab which will need to be done in a fasting state. Patients will also be schedules for a Cardiac CT scan performed at the hospital. All costs will be paid for by the study itself and patients will receive no bills from these exams.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • female
  • 55-65 years old

Exclusion criteria

  • ischemia
  • diabetes
  • statin or cholesterol lowering medicine use
  • cardiovascular disease: coronary artery disease, heart failure, arrhythmia, significant valvular disease
  • history of breast surgery or breast cancer
  • pregnant women
  • breastfeeding women
  • women unable to consent

Treatment and study plan

Cardiac CT Scan

Diagnostic Test

A non-contrast Cardiac CT Scan is a routine exam and a non-invasive scan to look for coronary artery calcium.

Bloodwork

Diagnostic Test

Blood will be drawn at a Northwell Lab. Participants will need to fast before the collection. Cholesterol levels, blood sugar (hemoglobin A1C), and markers for inflammation and kidney function will be analyzed.

Primary outcomes

  1. Coronary Artery Calcium Score

    Time frame: 7 days

    This result is obtained by the Cardiac CT Scan.

Secondary outcomes

  1. Incidence of Dyslipidemia

    Time frame: 3 days

    Obtained through laboratory testing

  2. High-sensitivity C-reactive protein elevation

    Time frame: 3 days

    Obtained through laboratory testing

  3. Lp(a) elevation

    Time frame: 3 days

    Obtained through laboratory testing

  4. HbA1c

    Time frame: 3 days

    Obtained through laboratory testing

Study contacts

Contact information is provided by the study sponsor or research team.

Elizabeth M Musso, BA

CONTACT

[email protected]

516-881-7012

Thara Ali, MD

CONTACT

[email protected]

917-951-8945

Sponsors and collaborators

Lead sponsor

Northwell Health

Other

Registry information

Official study title

Risk Stratification for Asymptomatic Women With Incidentally Found Breast Artery Calcification on Their Routine Screening Mammogram

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Sep 9, 2026
Registry last updated
Sep 9, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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