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| ID | Type | Description | Link |
|---|---|---|---|
| Not yet assigned | Other Grant/Funding Number | Chong Kun Dang | |
| Not yet assigned | Other Grant/Funding Number | Dotter |
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| Name | Class |
|---|---|
| Seoul National University Bundang Hospital | OTHER |
| Seoul National University Boramae Hospital | OTHER |
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To compare the effects of physiology- and imaging-guided PCI combined with optimal medical therapy (OMT) versus OMT alone on the recovery of left ventricular systolic function in patients with ischemic cardiomyopathy and multivessel coronary artery disease.
This study is a prospective, open-label, randomized, multicenter trial to test the safety and efficacy of physiology- and imaging-guided complete revascularization with PCI combined with optimal medical therapy (OMT) versus OMT alone on the recovery of left ventricle ejection fraction (LVEF) in patients with ischemic cardiomyopathy and multivessel coronary artery disease.
The primary hypothesis is that physiology- and imaging-guided complete revascularization with PCI combined with OMT will show greater improvements in LV systolic function at 6 months after randomization compared with OMT alone.
Patients with left ventricular ejection fraction (LVEF) less than 40% on echocardiography will undergo gadolinium-enhanced cardiac MRI to determine the underlying cause of cardiac dysfunction and assess the presence of viable myocardium. Among patients suspected of having ischemic cardiomyopathy, those who provide informed consent will be considered for enrollment. Eligible patients undergoing invasive coronary angiography and meeting inclusion and exclusion criteria will be randomly assigned to either: a group receiving physiology- and imaging-guided PCI in combination with optimal medical therapy, or a group receiving optimal medical therapy alone.
Improvement in LVEF will be evaluated using follow-up gadolinium-enhanced cardiac MRI at 6 months. Clinical outcomes will be assessed at 6 and 12 months, and long-term outcomes will be analyzed through 36-month follow-up.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Physiology-and imaging-guided PCI | Experimental | The goal is to achieve functional complete revascularization of major coronary arteries and their branches with diameters ≥2.5 mm. For lesions with ≥50% diameter stenosis, fractional flow reserve (FFR) measurement is mandatory. However, for severely stenotic lesions (>90%), revascularization may proceed at the operator's discretion without FFR assessment. In addition, intravascular ultrasound (IVUS) should be utilized during revascularization procedures and serve as an additional criterion for decision-making. All patients in the intervention group will receive optimal medical therapy identical to that provided to the optimal medical therapy group following PCI. |
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| Optimal medical treatment | Active Comparator | All study participants will receive guideline-directed medical therapy, including an angiotensin receptor-neprilysin inhibitor (ARNi) or an angiotensin-converting enzyme inhibitor (ACEi) or angiotensin receptor blocker (ARB), a beta-blocker (carvedilol or bisoprolol), an aldosterone antagonist, and an SGLT2 inhibitor (empagliflozin or dapagliflozin). Medications will be administered even at low doses, as tolerated based on the patient's clinical status. Antiplatelet agents and statins will be maintained throughout the study period, and ezetimibe or PCSK9 inhibitors may be added as needed. In addition, appropriate treatment will be provided for major cardiovascular risk factors such as hypertension, diabetes, and hyperlipidemia. Coexisting arrhythmias will be managed according to their respective guidelines. In the case of atrial fibrillation, active rate and rhythm control strategies will be implemented. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Physiology-and imaging-guided PCI | Procedure | The criteria for performing revascularization are as follows
For all target vessels and lesions identified for intervention, optimal revascularization should be pursued. The criteria for optimal revascularization are as follows, and operators are encouraged to achieve them:
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| Measure | Description | Time Frame |
|---|---|---|
| LV ejection fraction from GE-MRI | LV ejection fraction from gadolinium-enhanced MRI | At 6 months after randomization |
| Measure | Description | Time Frame |
|---|---|---|
| Changes in the transmural extent of myocardial infarction from GE-MRI | Changes in the transmural extent of myocardial infarction from GE-MRI | At 6 months after randomization |
| Number of improved dysfunctional myocardial segments from GE-MRI |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Doyeon Hwang, MD | Contact | 82-10-7446-2779 | cardiol.intv@gmail.com | |
| Junpil Yun, MD | Contact | 82-10-8001-9969 | junpilyun@gmail.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Seoul National University Hospital | Recruiting | Seoul | Chongno-gu | 03080 | South Korea |
The deidentified data will be shared after publication of first manuscript
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Data will be available within 12 months of study completion.
Data access requests will be reviewed by an external Independent Review Panel. Requestors will be required to sign a Data Access Agreement
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| Optimal medical treatment | Drug | All study participants will receive guideline-directed medical therapy. Even for patients assigned to the optimal medical therapy group, revascularization may be performed during follow-up if clinically indicated. If such a decision is made prior to the primary endpoint assessment, a gadolinium-enhanced cardiac MRI will be performed at the time of consideration to reassess myocardial viability. |
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Number of improved dysfunctional myocardial segments from GE-MRI
| At 6 months after randomization |
| Changes in the LV chamber size from GE MRI | Changes in the LV chamber size from GE MRI | At 6 months after randomization |
| LV ejection fraction from echocardiography | LV ejection fraction from echocardiography | At 6 months and 12 months after randomization |
| Number of improved dysfunctional myocardial segments from echocardiography | Number of improved dysfunctional myocardial segments from echocardiography | At 6 months and 12 months after randomization |
| Changes in the LV chamber size change from echocardiography | Changes in the LV chamber size change from echocardiography | At 6 months and 12 months after randomization |
| All-cause death | death from any cause | At 6 months, 12 months, and 36 months after randomization |
| Cardiovascular death | death from cardiovascular cause | At 6 months, 12 months, and 36 months after randomization |
| Non-fatal myocardial infarction | Non-fatal myocardial infarction | At 6 months, 12 months, and 36 months after randomization |
| Unplanned revascularization | Unplanned revascularization | At 6 months, 12 months, and 36 months after randomization |
| Hospitalization for heart failure | Hospitalization for heart failure | At 6 months, 12 months, and 36 months after randomization |
| EuroQol 5-Dimension 5-Level Questionnaire | EuroQol 5-Dimension 5-Level Questionnaire | At 6 months, 12 months, and 36 months after randomization |
| Brain natriuretic peptide (BNP or NT-Pro BNP) level | Brain natriuretic peptide (BNP or NT-Pro BNP) level | At 6 months, 12 months, and 36 months after randomization |