Acute Myocardial Infarction, No Reflow, Persisting Ischemia
Conditions
Keywords
Acute myocardial infarction, Persisting ischemia, No reflow, Intra-aortic balloon pump, Exhausted autoregulation
Brief summary
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
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.
Interventions
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.
Sponsors
Stichting Toegepaste Wetenschappen (project number 11052)
Maquet Cardiovascular
Lokien van Nunen
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | 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 |
Countries
Netherlands
Outcome results
None listed