Coronary Artery DiseaseSMART-STEPNCT05799092
Invasive Versus Non-invasive Approach in Symptomatic Patient With Non-High Risk Coronary Artery Stenosis
A study testing Invasive coronary angiography and Non-invasive functional test in people with Coronary Artery Disease, run by Samsung Medical Center at 22 sites in South Korea.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Coronary Artery Disease
- What is being tested?
- Invasive coronary angiography and Non-invasive functional test
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2,000 participants
- Where
- 22 sitesSouth Korea
- Study dates
- 2 Oct 2023to 31 Dec 2030
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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 CAD with previous MI, percutaneous coronary intervention (PCI), coronary artery bypass graft (CABG)
- 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.
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- Severe left ventricular systolic dysfunction (ejection fraction <30%)
- Intolerance to Aspirin, Clopidogrel, or Heparin.
- 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)
- Unwillingness or inability to comply with the procedures described in this protocol.
Trial locations and contacts
22 sites in 1 country. Contact the study team or a site near you to ask about taking part.
22 sites in 1 country
South Korea22 sites, 22 recruiting
- Recruiting
SoonChunHyang University Hospital Bucheon
Bucheon-si
Jon Suh, MD, PhD, marunada@gmail.com
Jon Suh, MD, PhD
- Recruiting
Kangwon National University Hospital
Chuncheon
Byung Ryul Cho, MD, PhD, heartcho@kangwon.ac.kr
Byung Ryul Cho, MD, PhD
- Recruiting
Chungbuk National University Hospital
Chungju
Woong Gil Choi, MD, PhD, wooggil7@gmail.com
Woong Gil Choi, MD, PhD
- Recruiting
Keimyung University Dongsan Medical Center
Daegu
Hyuck Jun Yoon, MD,PhD, hippsons@gmail.com
Hyuck Jun Yoon, MD,PhD
- Recruiting
Kyungpook National University Hospital
Daegu
Jang Hoon Lee, MD, PhD, ljhmh75@knu.ac.kr
Namkyun Kim, MD, PhD, namkyun.kim@knu.ac.kr
- Recruiting
Chungnam National University Hospital
Daejeon
Jin-Ok Jeong, MD, PhD, jojeong@cnu.ac.kr
Pil Sang Song, MD, PhD, pssong73@gmail.com
- Recruiting
Chonnam National University
Gwangju
Young Joon Hong, MD, PhD, hyj200@hanmail.net
Seung Hun Lee, MD, PhD, lsh8602@naver.com
- Recruiting
Chung-Ang University Gwangmyeong Hospital
Gwangmyeong
Sang Yeub Lee, MD, PhD, louisahj@gmail.com
Sang Yeub Lee, MD, PhD
- Recruiting
Inje university Ilsan Paik hospital
Ilsan
Joonhyung Doh, MD, PhD, joon.doh@gmail.com
Sung Eun Kim, MD, PhD, I0540@paik.ac.kr
- Recruiting
Gachon University Gil Medical Center
Incheon
Seung Hwan Han, MD, PhD, kheartist@gmail.com
Seung Hwan Han, MD, PhD
- Recruiting
Kwandong University Intl. ST. Mary's Hospital
Incheon
Hyung-Bok Park, MD, PhD, hyungbok7@gmail.com
Hyung-Bok Park, MD, PhD
- Recruiting
Gyeongsang National University Hospital
Jinju
Jin Sin Koh, MD, PhD, kjs0175@gmail.com
Hangyul Kim, MD, PhD, 13medicine@naver.com
- Recruiting
Seoul National University Bundang Hospital
Seongnam-si
Ki-Hyun Jeon, MD, PhD, imcardio@gmail.com
Ki-Hyun Jeon, MD, PhD
- Recruiting
Chung-Ang University Hospital
Seoul
Ho Youn Won, MD, PhD, nowhy@cau.ac.kr
Ho Youn Won, MD, PhD
- Recruiting
Ewha Womans University Mokdong Hospital
Seoul
Kyung-Jin Kim, MD, PhD, kyungjinkimkorea@gmail.com
So-Dam Jung, MD, PhD, cvdosam@gmail.com
- Recruiting
Ewha Womans University Seoul Hospital
Seoul
Sang Hoon Shin, MD, PhD, shin_sh@i.ewha.ac.kr
Sang Hoon Shin, MD, PhD
- Recruiting
Hanyang University Seoul Hospital, College of Medicine, Hanyang University
Seoul
Young-Hyo Lim, MD, PhD, mdoim@hanyang.ac.kr
Young-Hyo Lim, MD, PhD
- Recruiting
Kangbuk Samsung Hospital, Sungkyunkwan University School of Medicine
Seoul
Jong-Young Lee, MD, PhD, jyleeheart@naver.com
Woochan Kwon, MD, PhD, danced1@naver.com
- Recruiting
Korea University Anam Hospital
Seoul
Soon-Jun Hong, MD, PhD, psyche94@hanmail.net
Soon-Jun Hong, MD, PhD
- Recruiting
Samsung Medical Center
Seoul
Joo Myung Lee, MD, MPH, PhD, 82-2-3410-2575, drone80@hanmail.net
David Hong, MD, 82-2-3410-2575, hongdawi@naver.com
- Recruiting
Seoul National University Boramae Medical Center
Seoul
Hyun Sung Joh, MD, PhD, wingx4@naver.com
Hyun Sung Joh, MD, PhD
- Recruiting
Ajou University Hospital
Suwon
Hong-Seok Lim, MD, PhD, hslimmd@hanmail.net
Hong-Seok Lim, MD, PhD
About this study
Official title: Invasive Versus Non-invasive Approach in Symptomatic Patients With Non-High Risk Coronary Artery Stenosis (SMART-STEP Trial)
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).
Read the detailed description
CCTA has been emerged as useful diagnostic tool to evaluate CAD. Besides high diagnostic accuracy, CCTA has additional benefit of measuring the cumulative atherosclerotic burden and more accurately discriminating obstructive CAD with additional fractional flow reserve by CT (FFRCT), making it more predictive of a patient's prognosis. Recently, several randomized clinical trials have demonstrated the clinical utility of CCTA when compared with noninvasive stress test, which has been previously widely used as an initial assessment for stable chest pain, or invasive coronary angiography, which is the gold standard for diagnosing obstructive CAD.
On this background, CCTA, along with stress imaging test, is recommended as first step to diagnose obstructive CAD in patients with intermediate to high pretest probabilities with stable chest pain and is increasingly utilized. Although CCTA is increasingly used as initial assessment tool in these patients, there are insufficient studies to clearly establish the next step after obstructive CAD is confirmed in CCTA. Without high-risk features of CAD on CCTA, current guidelines suggest noninvasive stress imaging or FFRCT as class IIA recommendation. However, supporting evidence of these suggestions are mostly based on studies with low level of evidence. Furthermore, given the limited diagnostic performance of noninvasive stress test, concern remains whether it is safe to defer invasive coronary angiography based on the result from noninvasive stress test in patients with obstructive CAD on CCTA.
Therefore, this trial aims to compare clinical outcomes between invasive versus non-invasive approach as next diagnostic step in symptomatic patients with non-high risk obstructive CAD on CCTA.
- Conditions
- Coronary Artery Disease
- Being tested
- Invasive coronary angiography, Non-invasive functional test
- Keywords
- Coronary Computed Tomography Angiography, Non-High Risk Obstructive CAD, Diagnostic Approach, Invasive Coronary Angiography, Non-Invasive Functional Test
- Medical subject headings
- Coronary Artery Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Invasive coronary angiographyDiagnostic test
As alternative to non-invasive functional testing, invasive coronary angiography will be performed.
Non-invasive functional testDiagnostic test
Standard non-invasive functional testing will be performed.
| Study group | Role | What they receive |
|---|---|---|
| Invasive approach group | Experimental | Invasive coronary angiography will be performed as next diagnostic step in symptomatic patients with non-high risk obstructive CAD on CCTA.. Receives: Diagnostic Test: Invasive coronary angiography |
| Non-invasive approach group | Active comparator | Usual care of non-invasive ischemia testing (exercise electrocardiography [ECG], stress echocardiography by exercise or pharmacologic agent, nuclear test including SPECT or PET, stress cardiac magnetic resonance [MR]) will be performed as next diagnostic step in symptomatic patients with non-high risk obstructive CAD on CCTA. Receives: Diagnostic Test: Non-invasive functional test |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to first event of major adverse cardiac events (MACE)
MACE is a composite of death from any causes, myocardial infarction (MI), clinically driven unplanned revascularization.
Measured: 2 years after the last patient enrollment
Secondary outcomes (15)
All-cause death
All-cause death
Measured: 2 years after the last patient enrollment
Cardiac death
Cardiac death
Measured: 2 years after the last patient enrollment
Any MI
Defined by Forth Universal definition of MI
Measured: 2 years after the last patient enrollment
Spontaneous MI
Defined by Forth Universal definition of MI
Measured: 2 years after the last patient enrollment
Procedure-related MI
Defined by ARC II definition
Measured: 2 years after the last patient enrollment
Resuscitated cardiac arrest
Resuscitated cardiac arrest
Measured: 2 years after the last patient enrollment
Unplanned revascularization (clinically driven)
Unplanned revascularization (clinically driven)
Measured: 2 years after the last patient enrollment
Cerebrovascular accidents
Cerebrovascular accidents (ischemic or hemorrhagic)
Measured: 2 years after the last patient enrollment
Major adverse cardiac and cerebrovascular events
Major adverse cardiac and cerebrovascular events (MACCE, a composite of death, MI, clinically-driven unplanned revascularization, or cerebrovascular accident)
Measured: 2 years after the last patient enrollment
Rate of index coronary angiography
Rate of index coronary angiography
Measured: up to 30 days following randomization
Rate of index revascularization by PCI or CABG
Rate of index revascularization by PCI or CABG
Measured: up to 30 days following randomization
European Quality of Life-5 Dimensions
European Quality of Life-5 Dimensions
Measured: 6 months after initial management according to allocated diagnostic test
Seattle Angina Questionnaire
Seattle Angina Questionnaire
Measured: 6 months after initial management according to allocated diagnostic test
Total medical cost
Total medical cost
Measured: 2 years after the last patient enrollment
Procedure-related complications from invasive procedure
Procedure-related complications from invasive procedure
Measured: up to 30 days following randomization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Apr 2023
- Study start2 Oct 2023
- Primary completion30 Jun 2029 (estimated)
- Study completion31 Dec 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary Artery DiseaseStudies of the same condition, open and under way.
- More trials run by Samsung Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Pragmatic, prospective, multi-center, open label, randomized controlled, superiority trial.
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 2,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Samsung Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Joo Myung Lee, Samsung Medical Center
- Investigators
- Joo Myung Lee, MD, MPH, PhD, Principal investigator, Samsung Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05799092
- Sponsor's protocol ID
- SMC2023-02-096-001
- Acronym
- SMART-STEP
- Status last verified
- Nov 2025
- First submitted
- 22 Mar 2023
- Last updated
- 20 Nov 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: After publication of first manuscript and trial results, the de-identified data will be shared by permission of principle investigator, when asked
Study at a glance
From the registry record, last updated by the sponsor on 20 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Invasive Versus Non-invasive Approach in Symptomatic Patients With Non-High Risk Coronary Artery Stenosis (SMART-STEP Trial)
- ClinicalTrials.gov ID
- NCT05799092
- Acronym / sponsor ID
- SMART-STEP / SMC2023-02-096-001
- Conditions
- Coronary Artery Disease
- Keywords
- Coronary Computed Tomography Angiography, Non-High Risk Obstructive CAD, Diagnostic Approach, Invasive Coronary Angiography, Non-Invasive Functional Test
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 2,000 participants (estimated)
- Lead sponsor
- Samsung Medical CenterUniversity, hospital or other
- Study start
- 2 Oct 2023 (actual)
- Primary completion
- 30 Jun 2029 (estimated)
- Study completion
- 31 Dec 2030 (estimated)
- First posted
- 5 Apr 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Detailed description
CCTA has been emerged as useful diagnostic tool to evaluate CAD. Besides high diagnostic accuracy, CCTA has additional benefit of measuring the cumulative atherosclerotic burden and more accurately discriminating obstructive CAD with additional fractional flow reserve by CT (FFRCT), making it more predictive of a patient's prognosis. Recently, several randomized clinical trials have demonstrated the clinical utility of CCTA when compared with noninvasive stress test, which has been previously widely used as an initial assessment for stable chest pain, or invasive coronary angiography, which is the gold standard for diagnosing obstructive CAD.
On this background, CCTA, along with stress imaging test, is recommended as first step to diagnose obstructive CAD in patients with intermediate to high pretest probabilities with stable chest pain and is increasingly utilized. Although CCTA is increasingly used as initial assessment tool in these patients, there are insufficient studies to clearly establish the next step after obstructive CAD is confirmed in CCTA. Without high-risk features of CAD on CCTA, current guidelines suggest noninvasive stress imaging or FFRCT as class IIA recommendation. However, supporting evidence of these suggestions are mostly based on studies with low level of evidence. Furthermore, given the limited diagnostic performance of noninvasive stress test, concern remains whether it is safe to defer invasive coronary angiography based on the result from noninvasive stress test in patients with obstructive CAD on CCTA.
Therefore, this trial aims to compare clinical outcomes between invasive versus non-invasive approach as next diagnostic step in symptomatic patients with non-high risk obstructive CAD on CCTA.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Pragmatic, prospective, multi-center, open label, randomized controlled, superiority trial.
| Arm | Type | Receives |
|---|---|---|
| Invasive approach group | Experimental | Diagnostic Test: Invasive coronary angiographyInvasive coronary angiography will be performed as next diagnostic step in symptomatic patients with non-high risk obstructive CAD on CCTA.. |
| Non-invasive approach group | Active comparator | Diagnostic Test: Non-invasive functional testUsual care of non-invasive ischemia testing (exercise electrocardiography [ECG], stress echocardiography by exercise or pharmacologic agent, nuclear test including SPECT or PET, stress cardiac magnetic resonance [MR]) will be performed as next diagnostic step in symptomatic patients with non-high risk obstructive CAD on CCTA. |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (10 listed)
- 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 CAD with previous MI, percutaneous coronary intervention (PCI), coronary artery bypass graft (CABG)
- Known true anaphylaxis to contrast medium (not allergic reaction but anaphylactic shock)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Invasive coronary angiographyAs alternative to non-invasive functional testing, invasive coronary angiography will be performed. | Diagnostic test | Invasive approach group |
| Non-invasive functional testStandard non-invasive functional testing will be performed. | Diagnostic test | Non-invasive approach group |
Primary outcome
Time to first event of major adverse cardiac events (MACE)
Time frame: 2 years after the last patient enrollment
MACE is a composite of death from any causes, myocardial infarction (MI), clinically driven unplanned revascularization.
15 secondary outcomes
All-cause death
Time frame: 2 years after the last patient enrollment
Cardiac death
Time frame: 2 years after the last patient enrollment
Any MI
Time frame: 2 years after the last patient enrollment
Spontaneous MI
Time frame: 2 years after the last patient enrollment
Procedure-related MI
Time frame: 2 years after the last patient enrollment
Resuscitated cardiac arrest
Time frame: 2 years after the last patient enrollment
Unplanned revascularization (clinically driven)
Time frame: 2 years after the last patient enrollment
Cerebrovascular accidents
Time frame: 2 years after the last patient enrollment
Major adverse cardiac and cerebrovascular events
Time frame: 2 years after the last patient enrollment
Rate of index coronary angiography
Time frame: up to 30 days following randomization
Rate of index revascularization by PCI or CABG
Time frame: up to 30 days following randomization
European Quality of Life-5 Dimensions
Time frame: 6 months after initial management according to allocated diagnostic test
Seattle Angina Questionnaire
Time frame: 6 months after initial management according to allocated diagnostic test
Total medical cost
Time frame: 2 years after the last patient enrollment
Procedure-related complications from invasive procedure
Time frame: up to 30 days following randomization
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Nov 2025.
- Individual participant dataSharing planned: Yes. After publication of first manuscript and trial results, the de-identified data will be shared by permission of principle investigator, when asked
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Joo Myung Lee, MD, MPH, PhD principal investigator
Samsung Medical Center
22 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Invasive coronary angiography and Non-invasive functional test in people with Coronary Artery Disease, run by Samsung Medical Center at 22 sites in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 20 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 22 sites in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Joo Myung Lee, MD, MPH, PhD (82-2-3410-3391, drone80@hanmail.net), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time to first event of major adverse cardiac events (MACE) (time frame: 2 years after the last patient enrollment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Nov 2025.