Routine Versus As-Needed Stress Testing in Asymptomatic Patients With High-Risk Coronary Calcium
Recruiting now · Not applicable
Conditions studied: Coronary Atherosclerosis Due to Calcified Coronary Lesion
In brief
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.
Key facts
- Study ID
- NCT05796739
- Run by
- Samsung Medical Center
- People needed
- 3000
- Starts
- 2023-07-03
- Expected to finish
- 2029-12-31
- Last updated by the study team
- 2025-01-14
Who can join
Age: 19 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Subject must be at least 19 years of age. ② Asymptomatic patients with high-risk coronary calcium (Agatston Score ≥ 400)
You may not qualify if…
- 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 is running
- SamsungMedicalCenter — Seoul, South Korea (enrolling)
Full record on ClinicalTrials.gov
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