NCT05799092Recruiting
Invasive Versus Non-invasive Approach in Symptomatic Patient With Non-High Risk Coronary Artery Stenosis
Invasive Versus Non-invasive Approach in Symptomatic Patients With Non-High Risk Coronary Artery Stenosis (SMART-STEP Trial)
Source: ClinicalTrials.gov · Last updated 20 Nov 2025
Brief summary (registry, in English)
A pragmatic, prospective, multi-center, open label, randomized controlled, superiority trial. The study will compare clinical outcomes between invasive versus non-invasive approach as next diagnostic step in symptomatic patients with non-high risk obstructive coronary artery disease (CAD) on coronary computed tomography-angiography (CCTA).
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 2000 (estimated)
- First submitted
- 22 Mar 2023
- Start date
- 2 Oct 2023
- Primary completion date
- 30 Jun 2029
- Lead sponsor
- Samsung Medical Center
- Diseases
- Coronary artery disease
- NCT number
- NCT05799092
What you commit to
- Study type: Interventional
- Planned participants: 2000
- From 2 Oct 2023 to the primary completion date, 30 Jun 2029
- 22 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Known CAD with previous MI, percutaneous coronary intervention (PCI), coronary artery bypass graft (CABG)
Other illness
- Diagnosed or suspected acute coronary syndrome (ACS) requiring hospitalization or urgent or emergent testing (elevated cardiac troponin or CK-MB)
- High risk CAD (left main stenosis ≥ 50%; anatomically significant 3-vessel disease with ≥70% stenosis)
- Hemodynamically or clinically unstable condition (systolic BP \< 90 mmHg, ventricular arrhythmias, or persistent resting chest pain in ischemic nature despite adequate therapy
- Known true anaphylaxis to contrast medium (not allergic reaction but anaphylactic shock)
- Known significant congenital, severe valvular or cardiomyopathic (hypertrophic or dilated cardiomyopathy, or any other forms) process which could explain cardiac symptoms.
- 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)
Lab values
- Severe left ventricular systolic dysfunction (ejection fraction \<30%)
Other
- Intolerance to Aspirin, Clopidogrel, or Heparin.
- Unwillingness or inability to comply with the procedures described in this protocol.
Who the study is looking for
- Subject age ≥19 years old
- 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
- Any other clinical circumstance in which physician judged to proceed CCTA
- Obstructive CAD in CCTA (≥50% diameter stenosis)
- 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.
Age in the registry: 19 years to - · Sex: All · Does not accept healthy volunteers
Sites (22)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| SoonChunHyang University Hospital Bucheon Coordinator of this site? Confirm its status | Bucheon-si | South Korea | Recruiting |
| Kangwon National University Hospital Coordinator of this site? Confirm its status | Chuncheon | South Korea | Recruiting |
| Chungbuk National University Hospital Coordinator of this site? Confirm its status | Chungju | South Korea | Recruiting |
| Kyungpook National University Hospital Coordinator of this site? Confirm its status | Daegu | South Korea | Recruiting |
| Keimyung University - Dongsan Medical Center Coordinator of this site? Confirm its status | Daegu | South Korea | Recruiting |
| Chungnam National University Hospital Coordinator of this site? Confirm its status | Daejeon | South Korea | Recruiting |
| Chonnam National University Coordinator of this site? Confirm its status | Gwangju | South Korea | Recruiting |
| Chung-Ang University Gwangmyeong Hospital Coordinator of this site? Confirm its status | Gwangmyeong | South Korea | Recruiting |
| Inje University Ilsan Paik Hospital Coordinator of this site? Confirm its status | Ilsan | South Korea | Recruiting |
| Kwandong University Intl. ST. Mary's Hospital Coordinator of this site? Confirm its status | Incheon | South Korea | Recruiting |
| Gachon University Gil Medical Center Coordinator of this site? Confirm its status | Incheon | South Korea | Recruiting |
| Gyeongsang National University Hospital Coordinator of this site? Confirm its status | Jinju | South Korea | Recruiting |
| Seoul National University Bundang Hospital Coordinator of this site? Confirm its status | Seongnam-si | South Korea | Recruiting |
| Chung ang University Hospital Coordinator of this site? Confirm its status | Seoul | South Korea | Recruiting |
| Seoul National University Boramae Medical Center Coordinator of this site? Confirm its status | Seoul | South Korea | Recruiting |
| Kangbuk Samsung Hospital, Sungkyunkwan University School of Medicine Coordinator of this site? Confirm its status | Seoul | South Korea | Recruiting |
| Ewha Womans University Mokdong Hospital Coordinator of this site? Confirm its status | Seoul | South Korea | Recruiting |
| Korea University Anam Hospital Coordinator of this site? Confirm its status | Seoul | South Korea | Recruiting |
| Hanyang University Seoul Hospital, College of Medicine, Hanyang University Coordinator of this site? Confirm its status | Seoul | South Korea | Recruiting |
| Ewha Womans University Seoul Hospital Coordinator of this site? Confirm its status | Seoul | South Korea | Recruiting |
| Samsung Medical Center Coordinator of this site? Confirm its status | Seoul | South Korea | Recruiting |
| Ajou University Hospital Coordinator of this site? Confirm its status | Suwon | South Korea | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.