Coronary Atherosclerosis Due to Calcified Coronary LesionSMART-EXAMNCT05796739
Routine Versus As-Needed Stress Testing in Asymptomatic Patients With High-Risk Coronary Calcium
A study testing Non-invasive stress test and Medical treatment without further testing in people with Coronary Atherosclerosis Due to Calcified Coronary Lesion, run by Samsung Medical Center at 1 site in South Korea.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Coronary Atherosclerosis Due to Calcified Coronary Lesion
- What is being tested?
- Non-invasive stress test and Medical treatment without further testing
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 3,000 participants
- Where
- 1 siteSouth Korea
- Study dates
- 3 Jul 2023to 31 Dec 2029
- 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 must be at least 19 years of age. ② Asymptomatic patients with high-risk coronary calcium (Agatston Score ≥ 400)
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
South Korea1 site, 1 recruiting
- Recruiting
SamsungMedicalCenter
Seoul, 06351
Seunghyuk Choi, PhMD, 82-2-3410-3437
About this study
Official title: 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 (SMART-EXAM)
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.
Read the detailed description
The coronary artery calcium (CAC) scan, a marker of subclinical coronary atherosclerosis, has become popular for individuals at risk for atherosclerotic cardiovascular disease. CAC is strongly associated with atherosclerotic burden and predicts coronary heart disease events and mortality, regardless of their age, sex, race, or atherosclerotic cardiovascular disease (ASCVD) risk. Furthermore, the progression of CAC is associated with an increased risk for future hard and total coronary heart disease events. The use of CAC scoring was associated with significant improvements in the reclassification and discrimination of incident ASCVD. Nevertheless, the current guidelines recommend CAC measurement for selected cases only with borderline or intermediate risk of ASCVD. However, in real-world practice, CAC testing is increasingly being promoted to the public as a means of self-assessment of cardiovascular risk and is widely being used regardless of ASCVD risk.
Non-invasive stress testing is often recommended to exclude potentially dangerous coronary artery disease. However, stress testing in asymptomatic individuals has low sensitivity and specificity.9 Although the 2019 Primary Prevention of Cardiovascular Disease Guidelines do not comment on functional or invasive testing in asymptomatic individuals with a high CAC score, the 2009 Appropriate Use Criteria for Cardiac Radionuclide Imaging report gives a level A recommendation for obtaining a stress test in asymptomatic individuals with CAC score ≥400.10 In addition, the 2013 update of the 2009 document also considers stress imaging appropriate for patients with CAC score >100. However, there have been no large randomized controlled trials or observational studies that have evaluated the utility of functional or invasive testing in asymptomatic individuals free of ASCVD with high CAC scores. Theoretically, early detection and revascularization of ischemia producing lesions in asymptomatic patients with high-risk coronary calcification without proven ASCVD might reduce the future risk of major adverse cardiovascular events.
- Being tested
- Non-invasive stress test, Medical treatment without further testing
- Keywords
- Non-invasive stress test, Coronary calcification, Agatston score
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Non-invasive stress testDiagnostic test
Nuclear imaging, stress echocardiography, exercise electrocardiography, stress cardiac magnetic resonance imaging
Medical treatment without further testingDiagnostic test
Optimal medical treatment for primary prevention.
| Study group | Role | What they receive |
|---|---|---|
| Routine stress testing | Experimental | In this group, the preselected functional stress testing (exercise electrocardiography, stress echocardiography, nuclear imaging, or stress cardiac magnetic resonance imaging) will be performed within three months (± 2 months) according to the practice pattern of each participating center. Receives: Diagnostic Test: Non-invasive stress test |
| As-needed stress testing | Active comparator | In this group, optimal medical treatment will be performed by current guidelines without further testing. A stress test will be performed only when new symptoms (exertional chest pain or dyspnea) occur that may clinically suggest significant coronary artery disease. Receives: Diagnostic Test: Medical treatment without further testing |
What is being measured
The primary outcome is the main question the study is designed to answer.
Occurrence of major adverse cardiovascular events
a composite of death from cardiovascular causes, myocardial infarction, unplanned hospitalization leading to an urgent revascularization procedure, or heart failure hospitalization
Measured: up to 4.5 years of median follow-up
Secondary outcomes (12)
cardiovascular death
death from cardiovascular causes
Measured: up to 4.5 years of median follow-up
myocardial infarction
myocardial infarction
Measured: up to 4.5 years of median follow-up
unplanned hospitalization leading to an urgent revascularization procedure
unplanned hospitalization leading to an urgent revascularization procedure
Measured: up to 4.5 years of median follow-up
heart failure hospitalization
heart failure hospitalization
Measured: up to 4.5 years of median follow-up
all-cause death
death from any causes
Measured: up to 4.5 years of median follow-up
a composite of death from cardiovascular cause or myocardial infarction
a composite of death from cardiovascular cause or myocardial infarction
Measured: up to 4.5 years of median follow-up
any hospitalization
any hospitalization
Measured: up to 4.5 years of median follow-up
performing revascularization procedure
performing revascularization procedure
Measured: up to 4.5 years of median follow-up
performing invasive coronary angiography procedure
performing invasive coronary angiography procedure
Measured: up to 4.5 years of median follow-up
stroke
stroke
Measured: up to 4.5 years of median follow-up
bleeding
Bleeding Academic Research Consortium type 2-5
Measured: up to 4.5 years of median follow-up
total medical cost
total medical cost
Measured: up to 4.5 years of median follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Apr 2023
- Study start3 Jul 2023
- Primary completion30 Jun 2029 (estimated)
- Study completion31 Dec 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary Atherosclerosis Due to Calcified Coronary LesionStudies 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
- Masking
- None (open label)
- Enrolment
- 3,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Samsung Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Seung-Hyuk Choi, Samsung Medical Center
- Investigators
- Seung-Hyuk Choi, MD, Principal investigator, Samsung Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05796739
- Sponsor's protocol ID
- SMART-EXAM
- Acronym
- SMART-EXAM
- Status last verified
- Jan 2025
- First submitted
- 21 Mar 2023
- Last updated
- 14 Jan 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 14 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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 (SMART-EXAM)
- ClinicalTrials.gov ID
- NCT05796739
- Acronym / sponsor ID
- SMART-EXAM / SMART-EXAM
- Keywords
- Non-invasive stress test, Coronary calcification, Agatston score
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 3,000 participants (estimated)
- Lead sponsor
- Samsung Medical CenterUniversity, hospital or other
- Study start
- 3 Jul 2023 (actual)
- Primary completion
- 30 Jun 2029 (estimated)
- Study completion
- 31 Dec 2029 (estimated)
- First posted
- 3 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.
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.
Detailed description
The coronary artery calcium (CAC) scan, a marker of subclinical coronary atherosclerosis, has become popular for individuals at risk for atherosclerotic cardiovascular disease. CAC is strongly associated with atherosclerotic burden and predicts coronary heart disease events and mortality, regardless of their age, sex, race, or atherosclerotic cardiovascular disease (ASCVD) risk. Furthermore, the progression of CAC is associated with an increased risk for future hard and total coronary heart disease events. The use of CAC scoring was associated with significant improvements in the reclassification and discrimination of incident ASCVD. Nevertheless, the current guidelines recommend CAC measurement for selected cases only with borderline or intermediate risk of ASCVD. However, in real-world practice, CAC testing is increasingly being promoted to the public as a means of self-assessment of cardiovascular risk and is widely being used regardless of ASCVD risk.
Non-invasive stress testing is often recommended to exclude potentially dangerous coronary artery disease. However, stress testing in asymptomatic individuals has low sensitivity and specificity.9 Although the 2019 Primary Prevention of Cardiovascular Disease Guidelines do not comment on functional or invasive testing in asymptomatic individuals with a high CAC score, the 2009 Appropriate Use Criteria for Cardiac Radionuclide Imaging report gives a level A recommendation for obtaining a stress test in asymptomatic individuals with CAC score ≥400.10 In addition, the 2013 update of the 2009 document also considers stress imaging appropriate for patients with CAC score >100. However, there have been no large randomized controlled trials or observational studies that have evaluated the utility of functional or invasive testing in asymptomatic individuals free of ASCVD with high CAC scores. Theoretically, early detection and revascularization of ischemia producing lesions in asymptomatic patients with high-risk coronary calcification without proven ASCVD might reduce the future risk of major adverse cardiovascular events.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Routine stress testing | Experimental | Diagnostic Test: Non-invasive stress testIn this group, the preselected functional stress testing (exercise electrocardiography, stress echocardiography, nuclear imaging, or stress cardiac magnetic resonance imaging) will be performed within three months (± 2 months) according to the practice pattern of each participating center. |
| As-needed stress testing | Active comparator | Diagnostic Test: Medical treatment without further testingIn this group, optimal medical treatment will be performed by current guidelines without further testing. A stress test will be performed only when new symptoms (exertional chest pain or dyspnea) occur that may clinically suggest significant coronary artery disease. |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Subject must be at least 19 years of age. ② Asymptomatic patients with high-risk coronary calcium (Agatston Score ≥ 400)
Key exclusion criteria (3 listed)
- Documentation of objective evidence of inducible ischemia before enrollment
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 |
|---|---|---|
| Non-invasive stress testNuclear imaging, stress echocardiography, exercise electrocardiography, stress cardiac magnetic resonance imaging | Diagnostic test | Routine stress testing |
| Medical treatment without further testingOptimal medical treatment for primary prevention. | Diagnostic test | As-needed stress testing |
Primary outcome
Occurrence of major adverse cardiovascular events
Time frame: up to 4.5 years of median follow-up
a composite of death from cardiovascular causes, myocardial infarction, unplanned hospitalization leading to an urgent revascularization procedure, or heart failure hospitalization
12 secondary outcomes
cardiovascular death
Time frame: up to 4.5 years of median follow-up
myocardial infarction
Time frame: up to 4.5 years of median follow-up
unplanned hospitalization leading to an urgent revascularization procedure
Time frame: up to 4.5 years of median follow-up
heart failure hospitalization
Time frame: up to 4.5 years of median follow-up
all-cause death
Time frame: up to 4.5 years of median follow-up
a composite of death from cardiovascular cause or myocardial infarction
Time frame: up to 4.5 years of median follow-up
any hospitalization
Time frame: up to 4.5 years of median follow-up
performing revascularization procedure
Time frame: up to 4.5 years of median follow-up
performing invasive coronary angiography procedure
Time frame: up to 4.5 years of median follow-up
stroke
Time frame: up to 4.5 years of median follow-up
bleeding
Time frame: up to 4.5 years of median follow-up
total medical cost
Time frame: up to 4.5 years of median follow-up
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 14 Jan 2025.
- Individual participant dataSharing planned: Undecided
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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.
Seung-Hyuk Choi, MD principal investigator
Samsung Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Non-invasive stress test and Medical treatment without further testing in people with Coronary Atherosclerosis Due to Calcified Coronary Lesion, run by Samsung Medical Center at 1 site 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 1 inclusion and 3 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 14 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 Seung-Hyuk Choi, MD (82-2-3410-3419, sh1214.choi@samsung.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Occurrence of major adverse cardiovascular events (time frame: up to 4.5 years of median follow-up). 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 14 Jan 2025.