RecruitingNot ApplicableNCT05796739

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

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)

Sponsor

Samsung Medical Center

Enrollment

3,000 participants

Start Date

Jul 3, 2023

Study Type

INTERVENTIONAL

Conditions

Coronary Atherosclerosis Due to Calcified Coronary Lesion

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

Min Age: 19 Years

Plain Language Summary

Simplified for easier understanding

This trial compares routine heart stress testing versus testing only when symptoms develop in people who have high coronary calcium scores but no symptoms, to see which approach leads to better outcomes. **You may be eligible if...** - You are 19 years or older - You have no heart-related symptoms - You have a high coronary calcium score (Agatston score of 400 or higher) **You may NOT be eligible if...** - You already have documented reduced blood flow to the heart (ischemia) - You have a significant coronary artery blockage (70% or more) - You have had a previous stent or bypass surgery - You are pregnant or breastfeeding - Your life expectancy is less than 1 year - You are unwilling to follow the study requirements Talk to your doctor to see if this trial is right for you.

This is a simplified summary. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DIAGNOSTIC_TESTNon-invasive stress test

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

DIAGNOSTIC_TESTMedical treatment without further testing

Optimal medical treatment for primary prevention.

Locations(1)

SamsungMedicalCenter

Seoul, South Korea

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NCT05796739