North Shore University Hospital
Manhasset, New York, 11030, United States
Location status: Recruiting
NCT Number: NCT07809932
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.
Interested in participating?
Request Info55 year–65 year
Female
Observational
Manhasset, New York, 11030, United States
Location status: Recruiting
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
Time frame: 7 days
This result is obtained by the Cardiac CT Scan.
Time frame: 3 days
Obtained through laboratory testing
Time frame: 3 days
Obtained through laboratory testing
Time frame: 3 days
Obtained through laboratory testing
Time frame: 3 days
Obtained through laboratory testing
Contact information is provided by the study sponsor or research team.
Elizabeth M Musso, BA
CONTACT
Thara Ali, MD
CONTACT
Northwell Health
Other
Risk Stratification for Asymptomatic Women With Incidentally Found Breast Artery Calcification on Their Routine Screening Mammogram
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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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