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Clinical Trials in South Korea / NCT05796739
Recruiting Not applicable

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

NCT05796739 · tracked via the Priya Life Science South Korea tracker
Sponsor
Samsung Medical Center
Phase
Not applicable
Started
2023-07-03
Last updated
2025-01-14

Condition(s) studied

Coronary Atherosclerosis Due to Calcified Coronary Lesion

Investigational drug(s) / intervention(s)

Non-invasive stress testMedical treatment without further testing

Non-invasive stress test: Nuclear imaging, stress echocardiography, exercise electrocardiography, stress cardiac magnetic resonance imaging

Medical treatment without further testing: Optimal medical treatment for primary prevention.

Study 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

Sex
ALL
Min age
19 Years
Max age
—
Healthy volunteers
No
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.

Primary outcome measure(s)

  • Occurrence of major adverse cardiovascular events — up to 4.5 years of median follow-up
    a composite of death from cardiovascular causes, myocardial infarction, unplanned hospitalization leading to an urgent revascularization procedure, or heart failure hospitalization

Trial sites (1)

FacilityCityRegionStatus
SamsungMedicalCenter Seoul South Korea Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05796739 on ClinicalTrials.gov ↗ ← All trials in South Korea