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| Name | Class |
|---|---|
| Medtronic | INDUSTRY |
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The individual contribution of the specific injuring mechanisms surgical trauma, extracorporeal circulation, and ischemia/reperfusion to clinical outcome in coronary revascularisation remains to be elucidated. The effect of these factors is analyzed in this randomized clinical trial by comparing the 3 surgical approaches: Conventional Coronary Artery Bypass Grafting (CCAB), with extracorporeal circulation and cardioplegic arrest; Off-Pump Coronary Artery Bypass Grafting (OPCAB), avoids extracorporeal circulation and global myocardial ischemia; and Pump-Assisted Coronary Artery Bypass Grafting (PACAB), with an unloaded and beating heart. The hypothesis addressed by the study is that the surgical invasiveness increases in the order: OPCAB, PACAB, CCAB.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CCAB | Active Comparator | Conventional Coronary Artery Bypass |
|
| OPCAB | Active Comparator | Off-Pump Coronary Artery Bypass |
|
| PACAB | Active Comparator | Pump-Assisted Coronary Artery Bypass |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Conventional Coronary Artery Bypass | Procedure | Coronary artery bypass grafting with extracorporeal circulation and cardioplegic arrest |
|
| Measure | Description | Time Frame |
|---|---|---|
| All cause mortality | 1, 6, 12, 24, 48 month | |
| Myocardial infarction | 1, 6, 12, 24, 48 month | |
| Stroke | 1, 6, 12, 24, 48 month | |
| Low-output syndrome | in hospital | |
| duration of ventilation >= 24h | in hospital | |
| New requirement of hemodialysis | in hospital |
| Measure | Description | Time Frame |
|---|---|---|
| Completeness of revascularization | in hospital | |
| Re-revascularization of the target vessel (PCI and/or CABG) | 1, 6, 12, 24, 48 month | |
| Resource use (operative time, duration of stay in the intensive care unit, total hospital stay) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jochen Boergermann, MD | Martin-Luther-University Halle-Wittenberg | Principal Investigator |
| Rolf E Silber, MD | Martin-Luther-University Halle-Wittenberg | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Heart Center Coswig, Department of Cardiothoracic and Vascular Surgery | Coswig | 06869 | Germany | |||
| Martin-Luther-University Halle-Wittenberg, Department of Cardiothoracic Surgery |
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| ID | Term |
|---|---|
| D003327 | Coronary Disease |
| ID | Term |
|---|---|
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D014652 | Vascular Diseases |
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| ID | Term |
|---|---|
| D047549 | Coronary Artery Bypass, Off-Pump |
| ID | Term |
|---|---|
| D001026 | Coronary Artery Bypass |
| D009204 | Myocardial Revascularization |
| D006348 | Cardiac Surgical Procedures |
| D013504 | Cardiovascular Surgical Procedures |
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| Off-Pump Coronary Artery Bypass | Procedure | Coronary artery bypass grafting without extracorporeal circulation or global myocardial ischemia |
|
| Pump-Assisted Coronary Artery Bypass | Procedure | Coronary artery bypass grafting with a beating but unloaded heart by using extracorporeal circulation |
|
| in hospital |
| Halle |
| 06120 |
| Germany |
| D013514 | Surgical Procedures, Operative |
| D058017 | Vascular Grafting |
| D014656 | Vascular Surgical Procedures |
| D019616 | Thoracic Surgical Procedures |