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

Coronary Atherosclerosis Due to Calcified Coronary Lesion Clinical Trial

— SMART-EXAM  

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)

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05796739
• Other study ID #: SMART-EXAM
• Status: Not yet recruiting
• Phase: N/A
• Start date: May 1, 2023
• Est. completion date: December 31, 2029

Study information

• Verified date: March 2023
• Source: Samsung Medical Center
• Contact: Seung-Hyuk Choi, MD
• Phone: 82-2-3410-3419
• Email: sh1214.choi[@]samsung.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 3000
• Est. completion date: December 31, 2029
• Est. primary completion date: June 30, 2029
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years and older

Eligibility

Inclusion Criteria:

• Subject must be at least 19 years of age. ? 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 ? Pregnancy or breast feeding ? 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) ? Unwillingness or inability to comply with the procedures described in this protocol.

Related Conditions & MeSH terms

• Atherosclerosis
• Coronary Artery Disease
• Coronary Atherosclerosis Due to Calcified Coronary Lesion
• Myocardial Ischemia

Intervention

Diagnostic Test:
• 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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Samsung Medical Center

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	up to 4.5 years of median follow-up
Secondary	cardiovascular death	death from cardiovascular causes	up to 4.5 years of median follow-up
Secondary	myocardial infarction	myocardial infarction	up to 4.5 years of median follow-up
Secondary	unplanned hospitalization leading to an urgent revascularization procedure	unplanned hospitalization leading to an urgent revascularization procedure	up to 4.5 years of median follow-up
Secondary	heart failure hospitalization	heart failure hospitalization	up to 4.5 years of median follow-up
Secondary	all-cause death	death from any causes	up to 4.5 years of median follow-up
Secondary	a composite of death from cardiovascular cause or myocardial infarction	a composite of death from cardiovascular cause or myocardial infarction	up to 4.5 years of median follow-up
Secondary	any hospitalization	any hospitalization	up to 4.5 years of median follow-up
Secondary	performing revascularization procedure	performing revascularization procedure	up to 4.5 years of median follow-up
Secondary	performing invasive coronary angiography procedure	performing invasive coronary angiography procedure	up to 4.5 years of median follow-up
Secondary	stroke	stroke	up to 4.5 years of median follow-up
Secondary	bleeding	Bleeding Academic Research Consortium type 2-5	up to 4.5 years of median follow-up
Secondary	total medical cost	total medical cost	up to 4.5 years of median follow-up