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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).
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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.. |
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| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Invasive coronary angiography | Diagnostic Test | As alternative to non-invasive functional testing, invasive coronary angiography will be performed. |
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| Measure | Description | Time Frame |
|---|---|---|
| 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. | 2 years after the last patient enrollment |
| Measure | Description | Time Frame |
|---|---|---|
| All-cause death | All-cause death | 2 years after the last patient enrollment |
| Cardiac death | Cardiac death | 2 years after the last patient enrollment |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Joo Myung Lee, MD, MPH, PhD | Contact | 82-2-3410-3391 | drone80@hanmail.net | |
| David Hong, MD | Contact | 82-2-3410-3391 | hongdawi@naver.com |
| Name | Affiliation | Role |
|---|---|---|
| Joo Myung Lee, MD, MPH, PhD | Samsung Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| SoonChunHyang University Hospital Bucheon | Recruiting | Bucheon-si | South Korea |
After publication of first manuscript and trial results, the de-identified data will be shared by permission of principle investigator, when asked
After publication of first manuscript and trial results, the de-identified data will be shared by permission of principle investigator, when asked
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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Pragmatic, prospective, multi-center, open label, randomized controlled, superiority trial.
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Clinical outcome assessment will be performed under blinded assessment about the allocated treatment group.
| Non-invasive functional test | Diagnostic Test | Standard non-invasive functional testing will be performed. |
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| Any MI | Defined by Forth Universal definition of MI | 2 years after the last patient enrollment |
| Spontaneous MI | Defined by Forth Universal definition of MI | 2 years after the last patient enrollment |
| Procedure-related MI | Defined by ARC II definition | 2 years after the last patient enrollment |
| Resuscitated cardiac arrest | Resuscitated cardiac arrest | 2 years after the last patient enrollment |
| Unplanned revascularization (clinically driven) | Unplanned revascularization (clinically driven) | 2 years after the last patient enrollment |
| Cerebrovascular accidents | Cerebrovascular accidents (ischemic or hemorrhagic) | 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) | 2 years after the last patient enrollment |
| Rate of index coronary angiography | Rate of index coronary angiography | up to 30 days following randomization |
| Rate of index revascularization by PCI or CABG | Rate of index revascularization by PCI or CABG | up to 30 days following randomization |
| European Quality of Life-5 Dimensions | European Quality of Life-5 Dimensions | 6 months after initial management according to allocated diagnostic test |
| Seattle Angina Questionnaire | Seattle Angina Questionnaire | 6 months after initial management according to allocated diagnostic test |
| Total medical cost | Total medical cost | 2 years after the last patient enrollment |
| Procedure-related complications from invasive procedure | Procedure-related complications from invasive procedure | up to 30 days following randomization |
| Kangwon National University Hospital | Recruiting | Chuncheon | South Korea |
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| Chungbuk National University Hospital | Recruiting | Chungju | South Korea |
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| Keimyung University Dongsan Medical Center | Recruiting | Daegu | South Korea |
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| Kyungpook National University Hospital | Recruiting | Daegu | South Korea |
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| Chungnam National University Hospital | Recruiting | Daejeon | South Korea |
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| Chonnam National University | Recruiting | Gwangju | South Korea |
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| Chung-Ang University Gwangmyeong Hospital | Recruiting | Gwangmyeong | South Korea |
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| Inje university Ilsan Paik hospital | Recruiting | Ilsan | South Korea |
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| Gachon University Gil Medical Center | Recruiting | Incheon | South Korea |
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| Kwandong University Intl. ST. Mary's Hospital | Recruiting | Incheon | South Korea |
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| Gyeongsang National University Hospital | Recruiting | Jinju | South Korea |
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| Seoul National University Bundang Hospital | Recruiting | Seongnam-si | South Korea |
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| Chung-Ang University Hospital | Recruiting | Seoul | South Korea |
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| Ewha Womans University Mokdong Hospital | Recruiting | Seoul | South Korea |
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| Ewha Womans University Seoul Hospital | Recruiting | Seoul | South Korea |
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| Hanyang University Seoul Hospital, College of Medicine, Hanyang University | Recruiting | Seoul | South Korea |
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| Kangbuk Samsung Hospital, Sungkyunkwan University School of Medicine | Recruiting | Seoul | South Korea |
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| Korea University Anam Hospital | Recruiting | Seoul | South Korea |
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| Samsung Medical Center | Recruiting | Seoul | South Korea |
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| Seoul National University Boramae Medical Center | Recruiting | Seoul | South Korea |
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| Ajou University Hospital | Recruiting | Suwon | South Korea |
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| ID | Term |
|---|---|
| D003324 | Coronary Artery Disease |
| ID | Term |
|---|---|
| D003327 | Coronary Disease |
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D001161 | Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |
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