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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
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

Full criteria on ClinicalTrials.gov

Sites (22)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
SoonChunHyang University Hospital Bucheon
Coordinator of this site? Confirm its status
Bucheon-siSouth KoreaRecruiting
Kangwon National University Hospital
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ChuncheonSouth KoreaRecruiting
Chungbuk National University Hospital
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ChungjuSouth KoreaRecruiting
Kyungpook National University Hospital
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DaeguSouth KoreaRecruiting
Keimyung University - Dongsan Medical Center
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DaeguSouth KoreaRecruiting
Chungnam National University Hospital
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DaejeonSouth KoreaRecruiting
Chonnam National University
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GwangjuSouth KoreaRecruiting
Chung-Ang University Gwangmyeong Hospital
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GwangmyeongSouth KoreaRecruiting
Inje University Ilsan Paik Hospital
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IlsanSouth KoreaRecruiting
Kwandong University Intl. ST. Mary's Hospital
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IncheonSouth KoreaRecruiting
Gachon University Gil Medical Center
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IncheonSouth KoreaRecruiting
Gyeongsang National University Hospital
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JinjuSouth KoreaRecruiting
Seoul National University Bundang Hospital
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Seongnam-siSouth KoreaRecruiting
Chung ang University Hospital
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SeoulSouth KoreaRecruiting
Seoul National University Boramae Medical Center
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SeoulSouth KoreaRecruiting
Kangbuk Samsung Hospital, Sungkyunkwan University School of Medicine
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SeoulSouth KoreaRecruiting
Ewha Womans University Mokdong Hospital
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SeoulSouth KoreaRecruiting
Korea University Anam Hospital
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SeoulSouth KoreaRecruiting
Hanyang University Seoul Hospital, College of Medicine, Hanyang University
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SeoulSouth KoreaRecruiting
Ewha Womans University Seoul Hospital
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SeoulSouth KoreaRecruiting
Samsung Medical Center
Coordinator of this site? Confirm its status
SeoulSouth KoreaRecruiting
Ajou University Hospital
Coordinator of this site? Confirm its status
SuwonSouth KoreaRecruiting

This page is information, not medical advice. Discuss any trial with your doctor.