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临床试验/NCT07809932
NCT07809932招募中不适用

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

Northwell Health1 个研究点 分布在 1 个国家目标入组 200 人开始时间: 2026年7月31日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
入组人数
200
试验地点
1
主要终点
Coronary Artery Calcium Score

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
55 Years 至 65 Years(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • 55-65 years old

排除标准

  • 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

研究组 & 干预措施

BAC = 0 Group

干预措施: Cardiac CT Scan (Diagnostic Test)

BAC = 0 Group

干预措施: Bloodwork (Diagnostic Test)

BAC >0 Group

干预措施: Cardiac CT Scan (Diagnostic Test)

BAC >0 Group

干预措施: Bloodwork (Diagnostic Test)

结局指标

主要结局

Coronary Artery Calcium Score

时间窗: 7 days

This result is obtained by the Cardiac CT Scan.

次要结局

  • Incidence of Dyslipidemia(3 days)
  • High-sensitivity C-reactive protein elevation(3 days)
  • Lp(a) elevation(3 days)
  • HbA1c(3 days)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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