1. Acute ST-elevation myocardial infarction (Acuut ST-elevatie myocardinfarct)
Conditions
Interventions
Patients in cardiogenic pre-shock after ST-elevation myocardial infarction, treated by primary PCI, are randomized to either treatment with the Impella device, a percutaneous left ventricular assist d
or to standard treatment with IABP (intra-aortic balloon pump), which also has the purpose of supporting the left ventricle.
Sponsors
Dr.J.P.S.Henriques, MD, PhD
Academic Medical Center-University of Amsterdam, Department of Cardiology, room B2-116
Meibergdreef 9
1105 AZ
Amsterdam, the Netherlands
email:
j.p.henriques@amc.uva.nl
Phone +31205664585
Eligibility
Inclusion criteria
Inclusion criteria: 1. Delay between onset of chest pain and PCI less than 12 hours; 2. Anterior ST elevation myocardial infarction; 3. A clinical pre-shock state defined as: a. a heart rate >100/min and/or systolic blood pressure <100 mmHg after PCI procedure; b. one of the clinical signs of cardiogenic pre-shock, such as cold extremities, cyanosis, oliguria or decreased mental status.
Exclusion criteria
Exclusion criteria: 1. Younger than 30 or older than 75 years of age; 2. Legal incompetence, defined as lacking sufficient capacity to manage the patient¡¯s own affairs or to make or communicate important decisions concerning the patient¡¯s person, family, or property whether the lack of capacity is due to mental illness, mental retardation, epilepsy, cerebral palsy, autism, inebriety, senility, disease, injury, or similar cause or condition; 3. Full blown cardiogenic shock , defined hemodynamically as sustained systolic blood pressure ¡Ü 90 mmHg despite fluid hydration with ¡Ý 2 low dose or 1 high dose vasopressor(s) or inotrope(s) within the last 1 hour. The hemodynamic criteria are a cardiac index of no more than 2.2 liters per minute per square meter of body-surface area and a pulmonary-capillary wedge pressure of at least 15 mmHg if known. Pulmonary-artery catheterization is not required before randomization for patients; 4. Primary PCI at more than 12 hours after the onset of symptoms; 5. Actual primary PCI of the Right Coronary Artery; 6. Thrombolysis within 30 days before admission; 7. Blood transfusion in the previous 24 hours; 8. Tortuous aortic or femoral trajectory; 9. Congenital cardiac and or moderate to severe cardiac valve disease; 10. Mechanical aortic valve prosthesis; 11. Any contraindication for Magnetic Resonance Imaging i.e.: a. pacemaker; b. cerebrovascular clips; c. claustrophobia; 12. Left ventricular thrombus on the echocardiogram after primary PCI; 13. Stroke or transient ischemic attack within the previous 3 months; 14. Known hemoglobin diseases, such as sickle cell or thallasemia; 15. Known infection with human immunodeficiency virus (HIV), hepatitis B virus (HBV), or hepatitis C virus (HCV); 16. Serious known concomitant disease with a life expectancy of less than one year; 17. Chronic use of anti-inflammatory medication, except for the use of NSAID¡¯s (non-steroidal anti-inflammatory drugs); 18. Previous participation in this study or any other trial within the previous 30 days; 19. Current known pregnancy; 20. Circumstances that prevent follow-up (no permanent home or address, transient, etc.)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Efficiacy: Residual left ventricular ejection fraction, assessed by MRI at 4-month patient follow-up. Safety: The primary endpoint is the composite of death, myocardial infarction, target vessel revascularization and stroke (MACCE). | — |
Secondary
| Measure | Time frame |
|---|---|
| Efficiacy: 1. Differences in infarct size, measured by left ventricular ejection fraction (LVEF) and by contrast enhanced MRI-infarct size as well as differences in LV end-diastolic and end-systolic volumes and remodeling parameters at 4 months; 2. The difference of left ventricular ejection fraction (LVEF) measured by resting echocardiography before randomization (i.e. after primary PCI), before discharge and at 4 months; 3. Implantation delay, defined as the time between randomization and the time point at which the Impella support level is P=2 or the IABP actually starts pumping; 4. Hemodynamic parameters during hospitalization, measured by Swan Ganz catheter; 5. Enzymatic infarct size and several other biochemical parameters; 6. The need for and duration of mechanical ventilation; 7. The need for and duration of inotropic therapy; 8. The need for (temporary) dialysis for renal failure; 9. The need for and duration of hospitalization and stay at the intensive care and coronary care unit; 10. The change and differences in concentrations of NT-proBNP at hospital discharge, at 4 months and after 1 year; 11. The functional class according to the NYHA-Classification, with dyspnea or angina as the limiting factor at 30 days, 4 months and 12 months. Safety: The occurrence of device failure or malfunction, ventricular arrhythmias during placement, severe vascular events or hemolysis. | — |
Contacts
Public ContactA.E Engstrom
Academic Medical Center-University of Amsterdam, Department of Cardiology, room B2-115 Meibergdreef 9
Outcome results
None listed