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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03235622
Recruitment Status : Completed
First Posted : August 1, 2017
Last Update Posted : August 1, 2017
Sponsor:
Information provided by (Responsible Party):
Jung-Won Suh, Seoul National University Hospital

Tracking Information
First Submitted Date July 24, 2017
First Posted Date August 1, 2017
Last Update Posted Date August 1, 2017
Actual Study Start Date March 2011
Actual Primary Completion Date February 2013   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: July 29, 2017)
Presence of coronary plaque [ Time Frame: 5 years ]
Any coronary plaque in coronary CT angiography
Original Primary Outcome Measures Same as current
Change History No Changes Posted
Current Secondary Outcome Measures
 (submitted: July 29, 2017)
  • Characteristics of coronary plaque [ Time Frame: 5 years ]
    Plaque characteristics (fibrosis, calcification, lipid, thrombosis) in coronary CT angiography
  • Major adverse cardiovascular events [ Time Frame: 5 years ]
    Cardiac death, nonfatal myocardial infarction, ischemic stroke, coronary revascularization
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Women Health Cohort for Breast, Bone and Coronary Artery Disease
Official Title Women Health Cohort for Breast, Bone and Coronary Artery Disease
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.
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
Study Design Observational Model: Cohort
Time Perspective: Retrospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
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.
Condition Coronary Artery Disease
Intervention Diagnostic Test: Coronary CT angiography
Presence of coronary plaques Characteristic of coronary plaques
Other Names:
  • Bone DEXA
  • Mammography
Study Groups/Cohorts Not Provided
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: July 29, 2017)
2100
Original Actual Enrollment Same as current
Actual Study Completion Date July 2017
Actual Primary Completion Date February 2013   (Final data collection date for primary outcome measure)
Eligibility Criteria

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
Sex/Gender
Sexes Eligible for Study: Female
Ages 40 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number NCT03235622
Other Study ID Numbers B-1707-406-102
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: Undecided
Responsible Party Jung-Won Suh, Seoul National University Hospital
Study Sponsor Seoul National University Hospital
Collaborators Not Provided
Investigators
Principal Investigator: Jung-Won Suh, MD, PhD Seoul National University Bundang Hospital
PRS Account Seoul National University Hospital
Verification Date July 2017