heartinfarction Myocardial Infarction
Conditions
Interventions
Prior to randomization, all patients will undergo Iliac & femoral angiograms,
LVEDP measurement and an LV gram - to rule out contraindication for Impella CP®
placement. (An alternate method, such as
however, LVEDP measurement will still be necessary.)
Subjects randomized to the treatment arm, will undergo Impella CP® placement
through a femoral arterial sheath and the Impella device will be acti
Sponsors
Abiomed, Inc.
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: Inclusion Criteria: 1. Age 18-85 years 2. First myocardial infarction 3. Acute anterior STEMI with >=2 mm in 2 or more contiguous anterior leads or >=4 mm total ST segment deviation sum in the anterior leads V1-V4 AND anterior wall motion abnormality noted on a diagnostic quality left ventriculogram or echocardiogram 4. Patient presents to the hospital between 1 - 6 hours of ischemic pain onset 5. Patient indicated for PPCI 6. Patient or the patient*s LAR (where applicable) has signed Informed Consent
Exclusion criteria
Exclusion criteria: Exclusion Criteria: 1. Patient transferred from an outside hospital (OSH) where invasive coronary procedure was attempted (including diagnostic catheterization) 2. Unwitnessed cardiac arrest OR >=30 minutes of CPR prior to enrollment OR any cardiac arrest with impairment in mental status, cognition or any global or focal neurological deficit 3. Administration of fibrinolytic therapy within 24 hours prior to enrollment 4. Cardiogenic shock defined as: systemic hypotension (systolic BP 90mmHg), plus one of the following: any requirement for pressors/inotropes prior to arrival at the catheterization laboratory, clinical evidence of end organ hypoperfusion, or use of IABP or any other mechanical circulatory support device 5. Inferior STEMI or suspected right ventricular failure 6. Any contraindication or inability to Impella placement, including PVD, tortuous vascular anatomy, femoral bruits or absent pedal pulses 7. Severe aortic stenosis 8. Acute cardiac mechanical complication: LV free wall rupture OR Interventricular septum rupture OR Acute mitral regurgitation Medical Conditions & History: 9. Suspected or known pregnancy* 10. Suspected systemic active infection 11. History or known hepatic insufficiency prior to catheterization 12. On renal replacement therapy 13. COPD with home oxygen therapy or on chronic steroid therapy Cardiovascular History: 14. Known or evidence of prior myocardial infarction, including pathologic Q waves in non-anterior leads 15. Prior CABG or LAD PCI 16. History of heart failure (EF <40% or documented hospitalization for heart failure within one year prior to screening) 17. Prior aortic valve surgery or TAVR 18. Left bundle branch block (new or old) 19. History of stroke/TIA within the prior 3 months, any history of Intracranial Hemorrhage or any permanent neurological deficit 20. History of bleeding diathesis or known coagulopathy (including heparin-induced thrombocytopenia), any recent GU or GI bleed or will refuse blood transfusions 21. Patient on systemic anticoagulation pre-procedure (including factor Xa inhibitors, thrombin inhibitors, warfarin) Known Contraindication to: 22. Undergoing MRI or use of gadolinium [creatinine clearance CrCl<30 ml/min, non-compatible implant, claustrophobia] 23. Heparin, pork, pork products or contrast media 24. Receiving a drug-eluting stent General: 25. Participation in the active treatment or follow-up phase of another clinical study of an investigational drug or device which has not reached its primary endpoint. 26. Any organ condition, concomitant disease (e.g., psychiatric illness, severe alcoholism, or drug abuse, severe cancer, hepatic or kidney disease), with life expectancy of <=2 years or other abnormality that itself, or the treatment of which, could interfere with the conduct of the study or that, in the opinion of the Investigator and/or Sponsor*s medical monitor, would pose an unacceptable risk to the patient in the study. 27. Patient has other medical, social or psychological problems that, in the opinion of the Investigator, compromises the subject*s ability to give written informed consent and/or to comply with study procedures, including follow-up CMRs. 28. Patient belongs to a vulner
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary Endpoint: Infarct size normalized to the left ventricular mass (IS as % of LV mass), evaluated using Cardiac Magnetic Resonance (CMR) at 3-5 days following the index procedure. | — |
Secondary
| Measure | Time frame |
|---|---|
| Key Secondary Efficacy Endpoint: Composite clinical secondary endpoint (compared between groups using the Finkelstein-Schoenfeld statistic): I. Cardiovascular (CV) mortality [Time Frame: minimum follow-up of at least 12 months] II. Cardiogenic Shock at >=24h from enrollment [Time Frame: minimum follow-up of at least 12 months] III. LVAD or Heart Transplant [Time Frame: minimum follow-up of at least 12 months] IV. Heart Failure [Time Frame: minimum follow-up of at least 12 months] V. ICD or CRT placement [Time Frame: minimum follow-up of at least 12 months] VI. Infarct Size, as percent of Left Ventricular Mass [Time Frame: 3-5 days] Key Secondary Safety Endpoint: Impella CP® related Major Bleeding or Major Vascular complications with pre-specified performance goals [Time Frame: 30 days] Powered Secondary Endpoints: 1. Infarct size as a percentage of Area-at-Risk (AAR) [Time Frame: 3-5 days] 2. Percent Microvascular Obstruction (%MVO) [Time Frame: 3-5 days] 3. Left Ventricular End-Systolic Volume (LVESV) [Time Frame: 6 months] 4. Left Ventricular End-Diastolic Volume (LVEDV) [Time Frame: 6 months] 5. Left Ventricular End-Systolic Volume index (LVESVi) [Time Frame: 90 days] 6. Left Ventricular End-Diastolic Volume index (LVEDVi) [Time Frame: 90 days] 7. Ejection fraction (EF) [Time Frame: 6 months] Additional Secondary Endpoints: 1. Cardiogenic Shock at >=24h from enrollment [Time Frame: minimum follow-up of at least 12 months] 2. Development of Cardiogenic Shock [Time Frame: minimum follow-up of at least 12 months] 3. Heart Failure [Time Frame: minimum follow-up of at least 12 months] 4. Death or Heart Failure [Time Frame: minimum follow-up of at least 12 months ] 5. ICD or CRT placement [Time Frame: minimum follow-up of at least 12 months] 6. All-cause mortality [Time Frame: minimum follow-up of at least 12 months] 7. CV mortality [Time Frame: minimum follow-up of at least 12 months] Exploratory Endpoints: 1. All-cause mortality [Tim | — |
Countries
Netherlands
Outcome results
None listed