Intra-aortic Balloon Pump in Extensive Myocardial Infarction With Persistent Ischemia

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Survival Improvement in Extensive Myocardial Infarction With PERsistent Ischemia Following Intra-aortic Balloon Pump Implantation

Conditions
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Acute Myocardial Infarction, Persisting Ischemia, No Reflow

Intervention / Treatment
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* Device: Intra-aortic balloon pump


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Acute ST-segment elevation myocardial infarction with summed ST-segment deviation ≥15 mm. Insufficient ST-segment resolution (<50%) on the ECG made 10-30 minutes after the primary PCI in the catheterization laboratory. Exclusion Criteria: Initial summed ST-segment deviation less than 15 mm ST-segment resolution > 50% on the ECG performed in the catheterization laboratory Chest pain onset less than 2 or more than 8 hours before arrival Severe aortic valve stenosis/regurgitation Aortic abnormalities prohibitive for use of intra aortic balloon pump Full blown cardiogenic shock with immediate requirement of left ventricular assist device as judged necessary by the operator Inability to provide informed consent Pregnancy Inability to perform coronary angiography by the femoral approach

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: IABP group<br>After primary percutaneous coronary intervention, IABP will be implanted for 12-24 hours to alleviate persisting ischemia | Device: Intra-aortic balloon pump<br>* 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.<br>* Other names: Intra-aortic balloon counterpulsation;|
| No Intervention: Control group<br>After primary percutaneous coronary intervention, this group undergoes standard treatment according to the guidelines | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Acute myocardial infarction, Persisting ischemia, No reflow, Intra-aortic balloon pump, Exhausted autoregulation