Purpose

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.

Conditions

Eligibility

Eligible Ages
Between 55 Years and 65 Years
Eligible Sex
Female
Accepts 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

Study Design

Phase
Study Type
Observational
Observational Model
Cohort
Time Perspective
Prospective

Arm Groups

ArmDescriptionAssigned Intervention
BAC = 0 Group
  • Diagnostic Test: Cardiac CT Scan
    A non-contrast Cardiac CT Scan is a routine exam and a non-invasive scan to look for coronary artery calcium.
  • Diagnostic Test: Bloodwork
    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 Group
  • Diagnostic Test: Cardiac CT Scan
    A non-contrast Cardiac CT Scan is a routine exam and a non-invasive scan to look for coronary artery calcium.
  • Diagnostic Test: Bloodwork
    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.

Recruiting Locations

North Shore University Hospital
Manhasset, New York 11030

More Details

Status
Recruiting
Sponsor
Northwell Health

Study Contact

Thara Ali, MD
917-951-8945
Tali7@northwell.edu

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.

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.