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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

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.

Condition or disease Intervention/treatment
Coronary Artery Disease 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

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Study Type : Observational
Actual Enrollment : 2100 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Women Health Cohort for Breast, Bone and Coronary Artery Disease
Actual Study Start Date : March 2011
Actual Primary Completion Date : February 2013
Actual Study Completion Date : July 2017

Resource links provided by the National Library of Medicine



Intervention Details:
  • Diagnostic Test: Coronary CT angiography
    Presence of coronary plaques Characteristic of coronary plaques
    Other Names:
    • Bone DEXA
    • Mammography


Primary Outcome Measures :
  1. Presence of coronary plaque [ Time Frame: 5 years ]
    Any coronary plaque in coronary CT angiography


Secondary Outcome Measures :
  1. Characteristics of coronary plaque [ Time Frame: 5 years ]
    Plaque characteristics (fibrosis, calcification, lipid, thrombosis) in coronary CT angiography

  2. Major adverse cardiovascular events [ Time Frame: 5 years ]
    Cardiac death, nonfatal myocardial infarction, ischemic stroke, coronary revascularization



Information from the National Library of Medicine

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Ages Eligible for Study:   40 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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.
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03235622


Sponsors and Collaborators
Seoul National University Hospital
Investigators
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Principal Investigator: Jung-Won Suh, MD, PhD Seoul National University Bundang Hospital
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Jung-Won Suh, Professor, Seoul National University Hospital
ClinicalTrials.gov Identifier: NCT03235622    
Other Study ID Numbers: B-1707-406-102
First Posted: August 1, 2017    Key Record Dates
Last Update Posted: August 1, 2017
Last Verified: July 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Heart Diseases
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases