Women Health Cohort for Breast, Bone and Coronary Artery Disease (BBC)

A single center cohort which enrolled women who performed mammography, bone densitometry (DEXA), and coronary CT angiography in Seoul National University Bundang Hospital from March 2011 to February 2013.

Study Overview

• Status: Completed
• Conditions: Coronary Artery Disease
• Intervention / Treatment: Diagnostic test: Coronary CT angiography

Detailed Description

To evaluate whether bone mineral density and breast arterial calcification can predict coronary artery disease in women older than 40 years

• Study Type: Observational
• Enrollment (Actual): 2100

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

• Sampling Method: Non-Probability Sample

Study Population

• The number of women who met inclusion criteria was 2113.
• 13 women were excluded due to history of coronary revascularization (n=1) and breast surgery or intervention (n=12).
• Finally, 2100 women were enrolled to the BBC cohort.

Description

Inclusion Criteria:

• Women (≥ 40 years) who performed mammography, bone DEXA, and coronary CT angiography at health promotion center of Seoul National University Bundang Hospital.

Exclusion Criteria:

• Women who have history of breast surgery or intervention
• Women who have history of myocardial infarction or revascularization
• Too poor image quality of coronary CT angiography for interpretation
• Renal dysfunction with serum creatinine ≥ 1.4mg/dL

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Presence of coronary plaque	Any coronary plaque in coronary CT angiography	5 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Characteristics of coronary plaque	Plaque characteristics (fibrosis, calcification, lipid, thrombosis) in coronary CT angiography	5 years
Major adverse cardiovascular events	Cardiac death, nonfatal myocardial infarction, ischemic stroke, coronary revascularization	5 years

Collaborators and Investigators

• Sponsor: Seoul National University Hospital

Publications and helpful links

General Publications

• Yoon YE, Kim KM, Han JS, Kang SH, Chun EJ, Ahn S, Kim SM, Choi SI, Yun B, Suh JW. Prediction of Subclinical Coronary Artery Disease With Breast Arterial Calcification and Low Bone Mass in Asymptomatic Women: Registry for the Women Health Cohort for the BBC Study. JACC Cardiovasc Imaging. 2019 Jul;12(7 Pt 1):1202-1211. doi: 10.1016/j.jcmg.2018.07.004. Epub 2018 Aug 15.

Study record dates

Study Major Dates

• Study Start (ACTUAL): March 1, 2011
• Primary Completion (ACTUAL): February 1, 2013
• Study Completion (ACTUAL): July 1, 2017

Study Registration Dates

• First Submitted: July 24, 2017
• First Submitted That Met QC Criteria: July 29, 2017
• First Posted (ACTUAL): August 1, 2017

Study Record Updates

• Last Update Posted (ACTUAL): August 1, 2017
• Last Update Submitted That Met QC Criteria: July 29, 2017
• Last Verified: July 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Coronary Artery Disease; Myocardial Ischemia; Coronary Disease
• Other Study ID Numbers: B-1707-406-102

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No