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| ID | Type | Description | Link |
|---|---|---|---|
| STW-11052 | Other Identifier | Stichting Toegepaste Wetenschappen |
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| Name | Class |
|---|---|
| Stichting Toegepaste Wetenschappen (project number 11052) | UNKNOWN |
| Maquet Cardiovascular | INDUSTRY |
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Patients presenting with large myocardial infarction and signs of persistent ischemia after successful percutaneous coronary intervention, have a poor prognosis with respect to outcome and development of heart failure in the future.
The hypothesis of this study is that in patients in whom persistent ischemia is present, use of intra-aortic balloon pump will be beneficial and improve outcome.
In some patients presenting with large myocardial infarction and poor hemodynamic condition, intra-aortic balloon counterpulsation is effective in alleviating cardiogenic shock. In others, the use of intra-aortic balloon pump has no effect at all. The investigators believe this is dependent on the presence of persisting ischemia after successful epicardial reperfusion, known as no-reflow.
In the presence of persisting ischemia, the investigators believe us of the intra-aortic balloon pump will relieve ischemia and improve outcome.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| IABP group | Active Comparator | After primary percutaneous coronary intervention, IABP will be implanted for 12-24 hours to alleviate persisting ischemia |
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| Control group | No Intervention | After primary percutaneous coronary intervention, this group undergoes standard treatment according to the guidelines |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Intra-aortic balloon pump | Device | The intra-aortic balloon pump is placed in the descending thoracic aorta and inflates and deflates in synchrony with the cardiac cycle, providing diastolic augmentation and improving coronary blood flow, while deflating before systole, providing afterload and workload reduction for the myocardium. |
| Measure | Description | Time Frame |
|---|---|---|
| Composite endpoint of mortality, necessity for mechanical support due to hemodynamic deterioration, and hospital admission for heart failure | 6 months | |
| All-cause mortality | 30 days and 6 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Nico H.J. Pijls, MD PhD | Catharina Ziekenhuis Eindhoven | Principal Investigator |
| Lokien X van Nunen, MD | Catharina Ziekenhuis Eindhoven | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Catharina Hospital | Eindhoven | North Brabant | 5623EJ | Netherlands |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24170231 | Background | van Nunen LX, van 't Veer M, Schampaert S, Steerneman BJ, Rutten MC, van de Vosse FN, Pijls NH. Intra-aortic balloon counterpulsation in acute myocardial infarction: old and emerging indications. Neth Heart J. 2013 Dec;21(12):554-60. doi: 10.1007/s12471-013-0485-9. |
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| ID | Term |
|---|---|
| D007423 | Intra-Aortic Balloon Pumping |
| ID | Term |
|---|---|
| D015908 | Counterpulsation |
| D001243 | Assisted Circulation |
| D013514 | Surgical Procedures, Operative |
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