Routine Versus As-Needed Stress Testing in Asymptomatic Patients With High-Risk Coronary Calcium
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age19+
SponsorSamsung Medical Center
About this trial
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
This trial does not accept healthy volunteersQualifiers
Subject must be at least 19 years of age. ② Asymptomatic patients with high-risk coronary calcium (Agatston Score ≥ 400)
Disqualifiers
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.
Trial design
Design model
Parallel
Treatments tested in this trial
Non-invasive stress test
Diagnostic testNuclear imaging, stress echocardiography, exercise electrocardiography, stress cardiac magnetic resonance imaging
Medical treatment without further testing
Diagnostic testOptimal medical treatment for primary prevention.
Treatment groups
3,000 Participants
are divided into 2 treatment groupsGroup A: Routine stress testingExperimental treatment 1 intervention
Group B: As-needed stress testingActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
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
Time frame
up to 4.5 years of median follow-upSecondary outcomes
1
cardiovascular death
death from cardiovascular causes
Time frame
up to 4.5 years of median follow-up2
myocardial infarction
myocardial infarction
Time frame
up to 4.5 years of median follow-up3
unplanned hospitalization leading to an urgent revascularization procedure
unplanned hospitalization leading to an urgent revascularization procedure
Time frame
up to 4.5 years of median follow-up4
heart failure hospitalization
heart failure hospitalization
Time frame
up to 4.5 years of median follow-upSponsors and contacts
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Source ClinicalTrials.gov