Clinical trial NCT05796739: Routine Versus As-Needed Stress Testing in Asymptomatic Patients With High-Risk Coronary Calcium
Official title: 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 (SMART-EXAM)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Coronary Atherosclerosis Due to Calcified Coronary Lesion
Keywords: Non-invasive stress test
Coronary calcification
Agatston score
Lead sponsor: Samsung Medical Center
Sponsor class: OTHER
First posted: 2023-04-03
Enrollment: 3000
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

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.

Detailed description: The coronary artery calcium (CAC) scan, a marker of subclinical coronary atherosclerosis, has become popular for individuals at risk for atherosclerotic cardiovascular disease. CAC is strongly associated with atherosclerotic burden and predicts coronary heart disease events and mortality, regardless of their age, sex, race, or atherosclerotic cardiovascular disease (ASCVD) risk. Furthermore, the progression of CAC is associated with an increased risk for future hard and total coronary heart disease events. The use of CAC scoring was associated with significant improvements in the reclassification and discrimination of incident ASCVD. Nevertheless, the current guidelines recommend CAC measurement for selected cases only with borderline or intermediate risk of ASCVD. However, in real-world practice, CAC testing is increasingly being promoted to the public as a means of self-assessment of cardiovascular risk and is widely being used regardless of ASCVD risk.

Non-invasive stress testing is often recommended to exclude potentially dangerous coronary artery disease. However, stress testing in asymptomatic individuals has low sensitivity and specificity.9 Although the 2019 Primary Prevention of Cardiovascular Disease Guidelines do not comment on functional or invasive testing in asymptomatic individuals with a high CAC score, the 2009 Appropriate Use Criteria for Cardiac Radionuclide Imaging report gives a level A recommendation for obtaining a stress test in asymptomatic individuals with CAC score ≥400.10 In addition, the 2013 update of the 2009 document also considers stress imaging appropriate for patients with CAC score \>100. However, there have been no large randomized controlled trials or observational studies that have evaluated the utility of functional or invasive testing in asymptomatic individuals free of ASCVD with high CAC scores. Theoretically, early detection and revascularization of ischemia producing lesions in asymptomatic patients with high-risk coronary calcification without proven ASCVD might reduce the future risk of major adverse cardiovascular events.

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.

Primary outcomes:
measure: Occurrence of major adverse cardiovascular events
timeFrame: up to 4.5 years of median follow-up
Secondary outcomes:
measure: cardiovascular death
timeFrame: up to 4.5 years of median follow-up
measure: myocardial infarction
timeFrame: up to 4.5 years of median follow-up
measure: unplanned hospitalization leading to an urgent revascularization procedure
timeFrame: up to 4.5 years of median follow-up
measure: heart failure hospitalization
timeFrame: up to 4.5 years of median follow-up
measure: all-cause death
timeFrame: up to 4.5 years of median follow-up
measure: a composite of death from cardiovascular cause or myocardial infarction
timeFrame: up to 4.5 years of median follow-up
measure: any hospitalization
timeFrame: up to 4.5 years of median follow-up
measure: performing revascularization procedure
timeFrame: up to 4.5 years of median follow-up
measure: performing invasive coronary angiography procedure
timeFrame: up to 4.5 years of median follow-up
measure: stroke
timeFrame: up to 4.5 years of median follow-up
measure: bleeding
timeFrame: up to 4.5 years of median follow-up
measure: total medical cost
timeFrame: up to 4.5 years of median follow-up
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: SamsungMedicalCenter
Study officials:
affiliation: Samsung Medical Center
name: Seung-Hyuk Choi, MD
role: PRINCIPAL_INVESTIGATOR
References: