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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03235622
Other study ID # B-1707-406-102
Secondary ID
Status Completed
Phase N/A
First received July 24, 2017
Last updated July 29, 2017
Start date March 2011
Est. completion date July 2017

Study information

Verified date July 2017
Source Seoul National University Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


Description:

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


Recruitment information / eligibility

Status Completed
Enrollment 2100
Est. completion date July 2017
Est. primary completion date February 2013
Accepts healthy volunteers No
Gender Female
Age group 40 Years and older
Eligibility 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 Design


Intervention

Diagnostic Test:
Coronary CT angiography
Presence of coronary plaques Characteristic of coronary plaques

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Seoul National University Hospital

Outcome

Type Measure Description Time frame Safety issue
Primary Presence of coronary plaque Any coronary plaque in coronary CT angiography 5 years
Secondary Characteristics of coronary plaque Plaque characteristics (fibrosis, calcification, lipid, thrombosis) in coronary CT angiography 5 years
Secondary Major adverse cardiovascular events Cardiac death, nonfatal myocardial infarction, ischemic stroke, coronary revascularization 5 years
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