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NCT Number: NCT05796739

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

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.

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Key information

Age range

19 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

SamsungMedicalCenter

Seoul, 06351, South Korea

Location status: Recruiting

Location contact

Seunghyuk Choi, PhMD

CONTACT

82-2-3410-3437

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Non-invasive stress test

Diagnostic Test

Nuclear imaging, stress echocardiography, exercise electrocardiography, stress cardiac magnetic resonance imaging

Medical treatment without further testing

Diagnostic Test

Optimal medical treatment for primary prevention.

Primary outcomes

  1. Occurrence of major adverse cardiovascular events

    Time frame: 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

Secondary outcomes

  1. cardiovascular death

    Time frame: up to 4.5 years of median follow-up

    death from cardiovascular causes

  2. myocardial infarction

    Time frame: up to 4.5 years of median follow-up

    myocardial infarction

  3. unplanned hospitalization leading to an urgent revascularization procedure

    Time frame: up to 4.5 years of median follow-up

    unplanned hospitalization leading to an urgent revascularization procedure

  4. heart failure hospitalization

    Time frame: up to 4.5 years of median follow-up

    heart failure hospitalization

  5. all-cause death

    Time frame: up to 4.5 years of median follow-up

    death from any causes

  6. a composite of death from cardiovascular cause or myocardial infarction

    Time frame: up to 4.5 years of median follow-up

    a composite of death from cardiovascular cause or myocardial infarction

  7. any hospitalization

    Time frame: up to 4.5 years of median follow-up

    any hospitalization

  8. performing revascularization procedure

    Time frame: up to 4.5 years of median follow-up

    performing revascularization procedure

  9. performing invasive coronary angiography procedure

    Time frame: up to 4.5 years of median follow-up

    performing invasive coronary angiography procedure

  10. stroke

    Time frame: up to 4.5 years of median follow-up

    stroke

  11. bleeding

    Time frame: up to 4.5 years of median follow-up

    Bleeding Academic Research Consortium type 2-5

  12. total medical cost

    Time frame: up to 4.5 years of median follow-up

    total medical cost

Study contacts

Contact information is provided by the study sponsor or research team.

Ki Hong Choi

CONTACT

[email protected]

82-2-3410-6653

Seung-Hyuk Choi, MD

CONTACT

[email protected]

82-2-3410-3419

Sponsors and collaborators

Lead sponsor

Samsung Medical Center

Other

Registry information

Official study 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)

Acronym: SMART-EXAM

Important dates

Study start
2023
Primary completion
2029
Study completion
2029
First posted
Apr 3, 2023
Registry last updated
Jan 14, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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