An observational study in Cardiovascular Health Risk Communication, Cardiovascular (CV) Risk and Cardiovascular Disease Prevention, sponsored by Northwell Health. Recruiting at 1 site in United States. Open to female participants aged 55 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-09-09.
Sponsored by Northwell Health · Observational
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.
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.
719 studies on the registry are indexed under Communication; 159 are open to participants now.
This study's planned enrollment of 200 is above the median of 104 across 132 observational studies indexed under Communication.
Browse Communication studies →Northwell Health is the lead sponsor of 475 studies on the registry; 107 are open to participants now.
Of its 45 completed or terminated interventional studies of FDA-regulated products, 23 (51%) have results posted.
Counted across the registry records on this site, refreshed daily.
Potential subjects will be recruited from all women who underwent a mammogram at Northwell Health.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Diagnostic Test: Cardiac CT Scan · Diagnostic Test: Bloodwork
Diagnostic Test: Cardiac CT Scan · Diagnostic Test: Bloodwork
A non-contrast Cardiac CT Scan is a routine exam and a non-invasive scan to look for coronary artery calcium.
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.
Coronary Artery Calcium Score
This result is obtained by the Cardiac CT Scan.
Time frame: 7 days
Incidence of Dyslipidemia
Obtained through laboratory testing
Time frame: 3 days
High-sensitivity C-reactive protein elevation
Obtained through laboratory testing
Time frame: 3 days
Lp(a) elevation
Obtained through laboratory testing
Time frame: 3 days
HbA1c
Obtained through laboratory testing
Time frame: 3 days
Plan to share: No
Started Jul 2026 (actual). Primary completion is estimated for Aug 2027, 13 months after the start.
Of 51 non-industry observational studies under Communication, half reached primary completion within 25 months of starting (the median), counting those still running; a quarter within 10 and three quarters within 61. This study's planned 13 months is below that.
Counting every sponsor, half of 53 studies reached it within 25 months; a quarter within 9 and three quarters within 61.
How these figures are worked out, and which studies are left out of them.
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