Comparing invasive and non-invasive diagnostic approaches for coronary artery disease
Invasive Versus Non-invasive Approach in Symptomatic Patients With Non-High Risk Coronary Artery Stenosis (SMART-STEP Trial)
This study is testing whether invasive heart tests or non-invasive tests are better for helping patients with certain types of coronary artery disease after they've had a CT scan.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 2000 (estimated) |
| Ages | 19 Years and up |
| Sex | All |
| Sponsor | Samsung Medical Center Academic / other |
| Locations | 22 sites (Bucheon-si and 21 other locations) |
| Trial ID | NCT05799092 on ClinicalTrials.gov |
What this trial studies
This study aims to evaluate the clinical outcomes of invasive coronary angiography versus non-invasive functional tests in symptomatic patients with non-high risk obstructive coronary artery disease (CAD) confirmed by coronary computed tomography angiography (CCTA). It is a pragmatic, prospective, multi-center, open-label, randomized controlled trial designed to determine the most effective next step in diagnosis after CCTA. The study will assess the safety and efficacy of these approaches in a population that has been previously under-researched regarding follow-up diagnostics after CCTA. By comparing these two methods, the trial seeks to provide clearer guidelines for managing patients with obstructive CAD.
Who should consider this trial
Good fit: Ideal candidates are adults aged 19 and older with new or worsening chest pain and confirmed obstructive CAD on CCTA.
Not a fit: Patients with diagnosed or suspected acute coronary syndrome or high-risk CAD will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved diagnostic strategies for patients with coronary artery disease, potentially reducing unnecessary invasive procedures.
How similar studies have performed: Previous studies have shown the clinical utility of CCTA compared to traditional methods, but this specific comparison of follow-up approaches is less established.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Subject age ≥19 years old 2. Patients with new or worsening chest pain syndrome, equivalent symptoms, or abnormal laboratory test findings (suspected ischemic changes in electrocardiography, regional wall motion abnormality in echocardiography, or coronary calcium score \> 100) suspected for clinically significant CAD who are evaluated by CCTA 3. Any other clinical circumstance in which physician judged to proceed CCTA 4. Obstructive CAD in CCTA (≥50% diameter stenosis) 5. Subject who can verbally confirm understandings of risks, benefits, and treatment alternatives of receiving invasive approach and he/she or his/her legally authorized representative provides written informed consent prior to any study related procedure. Exclusion Criteria: 1. Diagnosed or suspected acute coronary syndrome (ACS) requiring hospitalization or urgent or emergent testing (elevated cardiac troponin or CK-MB) 2. High risk CAD (left main stenosis ≥ 50%; anatomically significant 3-vessel disease with ≥70% stenosis) 3. Hemodynamically or clinically unstable condition (systolic BP \< 90 mmHg, ventricular arrhythmias, or persistent resting chest pain in ischemic nature despite adequate therapy 4. Known CAD with previous MI, percutaneous coronary intervention (PCI), coronary artery bypass graft (CABG) 5. Known true anaphylaxis to contrast medium (not allergic reaction but anaphylactic shock) 6. Known significant congenital, severe valvular or cardiomyopathic (hypertrophic or dilated cardiomyopathy, or any other forms) process which could explain cardiac symptoms. 7. Severe left ventricular systolic dysfunction (ejection fraction \<30%) 8. Intolerance to Aspirin, Clopidogrel, or Heparin. 9. Non-cardiac co-morbid conditions are present with life expectancy \<2 year or that may result in protocol non-compliance (per site investigator's medical judgment) 10. Unwillingness or inability to comply with the procedures described in this protocol.
Where this trial is running
Bucheon-si and 21 other locations
- SoonChunHyang University Hospital Bucheon — Bucheon-si, South Korea (Recruiting)
- Kangwon National University Hospital — Chuncheon, South Korea (Recruiting)
- Chungbuk National University Hospital — Chungju, South Korea (Recruiting)
- Keimyung University Dongsan Medical Center — Daegu, South Korea (Recruiting)
- Kyungpook National University Hospital — Daegu, South Korea (Recruiting)
- Chungnam National University Hospital — Daejeon, South Korea (Recruiting)
- Chonnam National University — Gwangju, South Korea (Recruiting)
- Chung-Ang University Gwangmyeong Hospital — Gwangmyeong, South Korea (Recruiting)
- Inje university Ilsan Paik hospital — Ilsan, South Korea (Recruiting)
- Gachon University Gil Medical Center — Incheon, South Korea (Recruiting)
- Kwandong University Intl. ST. Mary's Hospital — Incheon, South Korea (Recruiting)
- Gyeongsang National University Hospital — Jinju, South Korea (Recruiting)
- Seoul National University Bundang Hospital — Seongnam-si, South Korea (Recruiting)
- Chung-Ang University Hospital — Seoul, South Korea (Recruiting)
- Ewha Womans University Mokdong Hospital — Seoul, South Korea (Recruiting)
- Ewha Womans University Seoul Hospital — Seoul, South Korea (Recruiting)
- Hanyang University Seoul Hospital, College of Medicine, Hanyang University — Seoul, South Korea (Recruiting)
- Kangbuk Samsung Hospital, Sungkyunkwan University School of Medicine — Seoul, South Korea (Recruiting)
- Korea University Anam Hospital — Seoul, South Korea (Recruiting)
- Samsung Medical Center — Seoul, South Korea (Recruiting)
- Seoul National University Boramae Medical Center — Seoul, South Korea (Recruiting)
- Ajou University Hospital — Suwon, South Korea (Recruiting)
Study contacts
- Principal investigator: Joo Myung Lee, MD, MPH, PhD — Samsung Medical Center
- Study coordinator: Joo Myung Lee, MD, MPH, PhD
- Email: drone80@hanmail.net
- Phone: 82-2-3410-3391
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.