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Breast Artery Calcification (BAC) and Female Cardiovascular Disease

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

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT07809932
Enrollment
200
Registered
2026-09-09
Start date
2026-07-31
Completion date
2027-08-01
Last updated
2026-09-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cardiovascular Health Risk Communication, Cardiovascular (CV) Risk, Cardiovascular Disease Prevention

Keywords

female health, Breast Artery Calcification, mammogram

Brief summary

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.

Detailed description

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.

Interventions

DIAGNOSTIC_TESTCardiac CT Scan

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

DIAGNOSTIC_TESTBloodwork

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.

Sponsors

Northwell Health
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
FEMALE
Age
55 Years to 65 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Coronary Artery Calcium Score7 daysThis result is obtained by the Cardiac CT Scan.

Secondary

MeasureTime frameDescription
Incidence of Dyslipidemia3 daysObtained through laboratory testing
High-sensitivity C-reactive protein elevation3 daysObtained through laboratory testing
Lp(a) elevation3 daysObtained through laboratory testing
HbA1c3 daysObtained through laboratory testing

Countries

United States

Contacts

CONTACTThara Ali, MD
Tali7@northwell.edu917-951-8945
CONTACTElizabeth M Musso, BA
emusso1@northwell.edu516-881-7012
PRINCIPAL_INVESTIGATORNisha Parikh, MD, MPH

Northwell Health

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Sep 10, 2026