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Routine versus As-Needed Stress Testing in Asymptomatic Patients with High-Risk Coronary Calcium

Not Applicable
Conditions
Diseases of the circulatory system
Registration Number
KCT0008326
Lead Sponsor
Samsung Medical Center
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
ot yet recruiting
Sex
All
Target Recruitment
3000
Inclusion Criteria

1. Subject must be at least 19 years of age.
2. Asymptomatic patients with high-risk coronary calcium (Agatston Score = 400)
3. Signed written informed consent

Exclusion Criteria

1. Documentation of objective evidence of inducible ischemia before enrollment
2. Presence of significant coronary artery stenosis (= 70% diameter stenosis) confirmed by coronary angiography or coronary computed tomography angiography before enrollment
3. History of coronary revascularization procedure
4. Pregnancy or breast feeding
5. Non-cardiac co-morbid conditions are present with life expectancy <1 year or that may result in protocol non-compliance (per site investigator’s medical judgment)
6. Unwillingness or inability to comply with the procedures described in this protocol.

Study & Design

Study Type
Interventional Study
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Occurrence of major adverse cardiovascular events (a composite of death from cardiovascular causes, myocardial infarction, unplanned hospitalization leading to an urgent revascularization procedure, or heart failure hospitalization)
Secondary Outcome Measures
NameTimeMethod
A.Death from cardiovascular causes;B.Myocardial infarction;C.Unplanned hospitalization leading to an urgent revascularization procedure;D.Heart failure hospitalization ;E.Death from any causes;F.A composite of death from cardiovascular cause or myocardial infarction;G.Any hospitalization;H.Performing revascularization procedure;I.Performing invasive coronary angiography procedure;J.Stroke;K.Bleeding (Bleeding Academic Research Consortium type 2-5) ;L.Total medical cost
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