Breast Artery Calcification (BAC) and Female Cardiovascular Disease
Risk Stratification for Asymptomatic Women With Incidentally Found Breast Artery Calcification on Their Routine Screening Mammogram
研究概览
地位
详细说明
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.
研究类型
注册 (估计的)
联系人和位置
学习联系方式
- 姓名:Thara Ali, MD
- 电话号码:917-951-8945
- 邮箱:Tali7@northwell.edu
研究联系人备份
- 姓名:Elizabeth M Musso, BA
- 电话号码:516-881-7012
- 邮箱:emusso1@northwell.edu
学习地点
-
-
New York
-
Manhasset、New York、美国、11030
- 招聘中
- North Shore University Hospital
-
-
参与标准
资格标准
适合学习的年龄
- 成人
- 年长者
接受健康志愿者
取样方法
研究人群
描述
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
学习计划
研究是如何设计的?
设计细节
队列和干预
团体/队列 |
干预/治疗 |
|---|---|
|
BAC = 0 Group
|
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.
|
|
BAC >0 Group
|
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.
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研究衡量的是什么?
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Coronary Artery Calcium Score
大体时间:7 days
|
This result is obtained by the Cardiac CT Scan.
|
7 days
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Incidence of Dyslipidemia
大体时间:3 days
|
Obtained through laboratory testing
|
3 days
|
|
High-sensitivity C-reactive protein elevation
大体时间:3 days
|
Obtained through laboratory testing
|
3 days
|
|
Lp(a) elevation
大体时间:3 days
|
Obtained through laboratory testing
|
3 days
|
|
HbA1c
大体时间:3 days
|
Obtained through laboratory testing
|
3 days
|
合作者和调查者
调查人员
- 首席研究员:Nisha Parikh, MD, MPH、Northwell Health
出版物和有用的链接
一般刊物
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (估计的)
研究完成 (估计的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
与本研究相关的术语
其他研究编号
- 25-0239
计划个人参与者数据 (IPD)
计划共享个人参与者数据 (IPD)?
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