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

July 29, 2017 updated by: Jung-Won Suh, Seoul National University Hospital
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

Intervention / Treatment

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

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Seoul National University Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

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

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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