Comparing routine and as-needed stress testing for patients with high 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)
Run by Samsung Medical Center · NCT05796739 · Data updated 2026-11-12
This study is testing whether regular stress tests are better than only doing them when needed for people who have a high coronary calcium score but no heart disease symptoms.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 19 Years and up |
| Sex | All |
| Enrollment | 3000 (estimated) |
| Sponsor | Samsung Medical Center Academic / other |
| Locations | 1 site (Seoul) |
| Status | Recruiting |
| Started | July 3, 2023 |
| Main results expected | June 30, 2029 |
| Study ends | December 31, 2029 |
| Registry record updated | January 14, 2025 |
| Trial ID | NCT05796739 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates for this study are asymptomatic individuals aged 19 and older with a high coronary calcium score of 400 or greater.
✕Probably not a fit
Patients with documented inducible ischemia or significant coronary artery stenosis, as well as those with a history of coronary revascularization, will not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
The SMART-EXAM trial aims to evaluate the differences in major adverse cardiovascular events between routine stress testing and as-needed stress testing in asymptomatic patients who have a high coronary calcium score (Agatston Score ≥ 400). This study focuses on individuals without proven atherosclerotic cardiovascular disease (ASCVD) and seeks to determine the effectiveness of stress testing in this specific population. By utilizing non-invasive stress tests, the trial will assess whether routine testing provides significant benefits over a more selective approach based on patient needs. The findings could influence guidelines on stress testing practices for high-risk individuals.
Why it matters
Potential benefit: If successful, this study could lead to more tailored and effective cardiovascular risk assessment strategies for asymptomatic patients with high coronary calcium.
How similar studies have gone: While there is existing literature on the use of coronary artery calcium scoring, this specific comparison of routine versus as-needed stress testing in asymptomatic patients is a novel approach.
Who can join: the full rules
Show full inclusion / exclusion 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.
Where it's running
-
SamsungMedicalCenter
Seoul, South Korea Recruiting
Study contacts
- Principal investigator: Seung-Hyuk Choi, MD — Samsung Medical Center
- Study coordinator: Seung-Hyuk Choi, MD
- Email: sh1214.choi@samsung.com
- Phone: 82-2-3410-3419
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.