NCT07809932

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
200

participants targeted

Target at P75+ for all trials

Timeline
10mo left

Started Jul 2026

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress18%
Jul 2026Aug 2027

Study Start

First participant enrolled

July 31, 2026

Completed
25 days until next milestone

First Submitted

Initial submission to the registry

August 25, 2026

Completed
15 days until next milestone

First Posted

Study publicly available on registry

September 9, 2026

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2027

Last Updated

September 9, 2026

Status Verified

September 1, 2026

Enrollment Period

1 year

First QC Date

August 25, 2026

Last Update Submit

September 8, 2026

Conditions

Cardiovascular Health Risk CommunicationCardiovascular (CV) RiskCardiovascular Disease Prevention

Keywords

female healthBreast Artery Calcificationmammogram

Outcome Measures

Primary Outcomes (1)

  • Coronary Artery Calcium Score

    This result is obtained by the Cardiac CT Scan.

    7 days

Secondary Outcomes (4)

  • Incidence of Dyslipidemia

    3 days

  • High-sensitivity C-reactive protein elevation

    3 days

  • Lp(a) elevation

    3 days

  • HbA1c

    3 days

Study Arms (2)

BAC = 0 Group

Diagnostic Test: Cardiac CT ScanDiagnostic Test: Bloodwork

BAC >0 Group

Diagnostic Test: Cardiac CT ScanDiagnostic Test: Bloodwork

Interventions

Cardiac CT ScanDIAGNOSTIC_TEST

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

BAC = 0 GroupBAC >0 Group
BloodworkDIAGNOSTIC_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.

BAC = 0 GroupBAC >0 Group

Eligibility Criteria

Age55 Years - 65 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsFemales are invited to participate.
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Potential subjects will be recruited from all women who underwent a mammogram at Northwell Health.

You may qualify if:

  • female
  • years old

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

North Shore University Hospital

Manhasset, New York, 11030, United States

RECRUITING

Related Publications (7)

  • Monticciolo DL, Malak SF, Friedewald SM, Eby PR, Newell MS, Moy L, Destounis S, Leung JWT, Hendrick RE, Smetherman D. Breast Cancer Screening Recommendations Inclusive of All Women at Average Risk: Update from the ACR and Society of Breast Imaging. J Am Coll Radiol. 2021 Sep;18(9):1280-1288. doi: 10.1016/j.jacr.2021.04.021. Epub 2021 Jun 19.

    PMID: 34154984BACKGROUND

  • Venkatesan P. New US breast cancer screening recommendations. Lancet Oncol. 2023 Jun;24(6):e242. doi: 10.1016/S1470-2045(23)00238-3. Epub 2023 May 18. No abstract available.

    PMID: 37211021BACKGROUND

  • Koh TJW, Tan HJH, Ravi PRJ, Sng JWZ, Yeo TC, Tan BYQ, Chai P, Yeo LLL, Chan MY, Kong WKF, Wong RCC, Teo YH, Ho JSY, Teo YN, Sia CH. Association Between Breast Arterial Calcifications and Cardiovascular Disease: A Systematic Review and Meta-analysis. Can J Cardiol. 2023 Dec;39(12):1941-1950. doi: 10.1016/j.cjca.2023.07.024. Epub 2023 Jul 26.

    PMID: 37506765BACKGROUND

  • Iribarren C, Chandra M, Lee C, Sanchez G, Sam DL, Azamian FF, Cho HM, Ding H, Wong ND, Molloi S. Breast Arterial Calcification: a Novel Cardiovascular Risk Enhancer Among Postmenopausal Women. Circ Cardiovasc Imaging. 2022 Mar;15(3):e013526. doi: 10.1161/CIRCIMAGING.121.013526. Epub 2022 Mar 15.

    PMID: 35290077BACKGROUND

  • Bui QM, Daniels LB. A Review of the Role of Breast Arterial Calcification for Cardiovascular Risk Stratification in Women. Circulation. 2019 Feb 19;139(8):1094-1101. doi: 10.1161/CIRCULATIONAHA.118.038092.

    PMID: 30779650BACKGROUND

  • Bots SH, Peters SAE, Woodward M. Sex differences in coronary heart disease and stroke mortality: a global assessment of the effect of ageing between 1980 and 2010. BMJ Glob Health. 2017 Mar 27;2(2):e000298. doi: 10.1136/bmjgh-2017-000298. eCollection 2017.

    PMID: 28589033BACKGROUND

  • Wilmot KA, O'Flaherty M, Capewell S, Ford ES, Vaccarino V. Coronary Heart Disease Mortality Declines in the United States From 1979 Through 2011: Evidence for Stagnation in Young Adults, Especially Women. Circulation. 2015 Sep 15;132(11):997-1002. doi: 10.1161/CIRCULATIONAHA.115.015293. Epub 2015 Aug 24.

    PMID: 26302759BACKGROUND

Study Officials

  • Nisha Parikh, MD, MPH

    Northwell Health

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Thara Ali, MD

CONTACT

917-951-8945Tali7@northwell.edu

Elizabeth M Musso, BA

CONTACT

516-881-7012emusso1@northwell.edu

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 25, 2026

First Posted

September 9, 2026

Study Start

July 31, 2026

Primary Completion (Estimated)

August 1, 2027

Study Completion (Estimated)

August 1, 2027

Last Updated

September 9, 2026

Record last verified: 2026-09

Data Sharing

IPD Sharing
Will not share

Locations

US(1)