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Recruiting NCT05796739

Routine Versus As-Needed Stress Testing in Asymptomatic Patients With High-Risk Coronary Calcium

Trial Parameters

Condition Coronary Atherosclerosis Due to Calcified Coronary Lesion
Sponsor Samsung Medical Center
Study Type INTERVENTIONAL
Phase N/A
Enrollment 3,000
Sex ALL
Min Age 19 Years
Max Age N/A
Start Date 2023-07-03
Completion 2029-06-30
Interventions
Non-invasive stress testMedical treatment without further testing

Brief Summary

The purpose of the SMART-EXAM (SMart Angioplasty Research Team-Pragmatic Randomized Trial for Comparing Routine versus As-Needed EXercise or Pharmacologic Stress Testing in Asymptomatic Patients with High-Risk Coronary CalciuM) trial is to compare the major adverse cardiovascular events between routine stress testing and as-needed stress testing in asymptomatic patients with high-risk coronary calcium (Agatston Score ≥ 400) without proven ASCVD.

Eligibility Criteria

Inclusion Criteria: * Subject must be at least 19 years of age. ② Asymptomatic patients with high-risk coronary calcium (Agatston Score ≥ 400) Exclusion Criteria: * Documentation of objective evidence of inducible ischemia before enrollment * Presence of significant coronary artery stenosis (≥ 70% diameter stenosis) confirmed by coronary angiography or coronary computed tomography angiography before enrollment * 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.

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