NCT03235622

Brief Summary

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
2,100

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Mar 2011

Longer than P75 for all trials

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2011

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2013

Completed
4.4 years until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2017

Completed
23 days until next milestone

First Submitted

Initial submission to the registry

July 24, 2017

Completed
8 days until next milestone

First Posted

Study publicly available on registry

August 1, 2017

Completed
Last Updated

August 1, 2017

Status Verified

July 1, 2017

Enrollment Period

1.9 years

First QC Date

July 24, 2017

Last Update Submit

July 29, 2017

Conditions

Outcome Measures

Primary Outcomes (1)

  • Presence of coronary plaque

    Any coronary plaque in coronary CT angiography

    5 years

Secondary Outcomes (2)

  • Characteristics of coronary plaque

    5 years

  • Major adverse cardiovascular events

    5 years

Interventions

Presence of coronary plaques Characteristic of coronary plaques

Also known as: Bone DEXA, Mammography

Eligibility Criteria

Age40 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • 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.

MeSH Terms

Conditions

Coronary Artery Disease

Interventions

Mammography

Condition Hierarchy (Ancestors)

Coronary DiseaseMyocardial IschemiaHeart DiseasesCardiovascular DiseasesArteriosclerosisArterial Occlusive DiseasesVascular Diseases

Intervention Hierarchy (Ancestors)

RadiographyDiagnostic ImagingDiagnostic Techniques and ProceduresDiagnosis

Study Officials

  • Jung-Won Suh, MD, PhD

    Seoul National University Bundang Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

July 24, 2017

First Posted

August 1, 2017

Study Start

March 1, 2011

Primary Completion

February 1, 2013

Study Completion

July 1, 2017

Last Updated

August 1, 2017

Record last verified: 2017-07