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| Name | Class |
|---|---|
| Institute of Cardiovascular Diseases, Vojvodina | OTHER |
| Military Medical Academy, Belgrade, Serbia | OTHER |
| Clinical Center Kragujevac | OTHER |
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The study will compare clinical outcomes between complete revascularization during hospitalization for ST elevation myocardial infarction (STEMI) and intervention after 30 days and intervention based on outpatient non-invasive ischemia testing in patients with multivessel coronary artery disease (MVD) presenting with first ever ST elevation myocardial infarction.
This study is prospective, randomized, multicentre, open label study in patients with ST elevation myocardial infarction (STEMI) with multivessel coronary artery disease (MVD) defined as >70% stenosis in a non-culprit vessel, initially treated with culprit only primary PCI. The patients will be enrolled in four high volume PCI centers after successful culprit only primary PCI and then randomly assigned to one of three treatment arms:1. complete revascularization of all non-culprit significant lesions in a single session during initial hospitalization; 2. same revascularization in a single session after 30 days; 3.revascularization or it's deferral based on ischemia testing using Dobutamin stress echocardiography. The study will explore differences in occurrence of major adverse cardio-cerebral events (cardiac death, repeated myocardial infarction, cerebrovascular accident and repeated revascularization) and complications of interventions during 12 months follow-up.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| complete PCI at initial hospitalization | Experimental | Staged, complete revascularization of all non-culprit significant lesions in a single PCI session during initial hospitalization for ST elevation myocardial infarction |
|
| complete PCI after 30 days | Experimental | Staged, complete revascularization of all non-culprit significant lesions in a single PCI session after 30 days from initial hospitalization for ST elevation myocardial infarction |
|
| Dobutamine stress testing | Active Comparator | Revascularization by PCI or deferral of revascularization of non-culprit coronary artery lesions based on ischemia testing using Dobutamin stress echocardiography |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PCI | Procedure | percutaneous angioplasty and stent implantation in coronary artery with significant atherosclerosis and stenosis |
|
| Measure | Description | Time Frame |
|---|---|---|
| major adverse cardio-cerebral events | cardiac death, repeated myocardial infarction, cerebrovascular accident and repeated revascularization | one year |
| Measure | Description | Time Frame |
|---|---|---|
| cardiac death | Occurence of death caused by cardiac condition | one year |
| repeated myocardial infarction | Occurrence of repeated myocardial infarction in the study groups |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Aleksandar N Neskovic, MD, PhD | Clinical Hospital Center Zemun | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Military Medical Academy | Belgrade | 11000 | Serbia | |||
| Clinical Hospital Center Zemun |
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| ID | Term |
|---|---|
| D009203 | Myocardial Infarction |
| ID | Term |
|---|---|
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D014652 | Vascular Diseases |
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| ID | Term |
|---|---|
| D062645 | Percutaneous Coronary Intervention |
| ID | Term |
|---|---|
| D057510 | Endovascular Procedures |
| D014656 | Vascular Surgical Procedures |
| D013504 | Cardiovascular Surgical Procedures |
| D013514 | Surgical Procedures, Operative |
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| dobutamine stress echocardiography | Procedure | Echocardiographic stress test of provoked myocardial ischemia using dobutamine |
|
| one year |
| complications of percutaneous coronary intervention | Occurrence of vascular complications of PCI, contrast induced nephropathy (CIN) and bleeding events | one year |
| stent thrombosis | Occurrence of stent thrombosis based on Associated Research Consortium (ARC) criteria | two years |
| hospitalization for heart failure | Occurrence of hospitalization for heart failure in the study groups | one year |
| Belgrade |
| 11080 |
| Serbia |
| Clinical Center Kragujevac | Kragujevac | 34000 | Serbia |
| Institute for cardiovascular diseases Vojvodine | Novi Sad | 21000 | Serbia |
| D007238 |
| Infarction |
| D007511 | Ischemia |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D009336 | Necrosis |
| D019060 | Minimally Invasive Surgical Procedures |