STEMI
Conditions
Keywords
Infarct Size, Impella, Unloading, Left Ventricle, PPCI, STEMI
Brief summary
Direct active unloading of the left ventricle with the Impella CP System prior to PPCI in patients with ST-elevation myocardial infarction (STEMI) is safe and feasible
Detailed description
A multi-center, prospective, randomized, two-arm feasibility trial to assess the potential role of unloading with the Impella CP prior to revascularization in reducing infarct size. The study design includes 1:1 randomization between: 1) Delay Arm: 30 minutes of unloading with Impella CP prior to primary percutaneous coronary intervention (PPCI); and 2) Immediate Arm: initiation of Impella CP unloading followed immediately by PPCI. Study Hypothesis: Direct active unloading of the left ventricle with the Impella CP System prior to PPCI in patients with ST-elevation myocardial infarction (STEMI) is safe and feasible
Interventions
DEVICEImpella unloading prior to PPCI
Impella unloading prior to PPCI
Sponsors
Abiomed Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
21 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
Main Inclusion Criteria: * Age 21-80 years * First myocardial infarction * 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 * Signed Informed Consent Main
Exclusion criteria
* Cardiogenic shock defined as: systemic hypotension (systolic BP less than 90 mmHg or the need for inotropes/pressors to maintain a systolic BP Greater than 90mmHg) plus one of the following: any requirement for pressors/inotropes prior to arrival at the cath lab, clinical evidence of end organ hypoperfusion, lactate level greater than 2.5mmol/L * Inferior STEMI or suspected right ventricular failure * Suspected or known pregnancy * Suspected active infection * History or known hepatic insufficiency prior to catheterization * On dialysis therapy * Known contraindication to: * Undergoing MRI or use of gadolinium * Heparin, pork, pork products or contrast media * Receiving a drug-eluting stent * Participation in the active treatment or follow-up phase of another clinical study of an investigational drug or device
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Infarct size at 30 Days | 30 Days | Assessment of infarct size as percent of left ventricular (LV) mass, evaluated using CMR, at 30 days post-PPCI |
| MACCE at 30 Days | 30 Days | A composite of the following Major Adverse Cardiovascular and Cerebrovascular Events (MACCE) at 30 days: * Cardiovascular mortality * Re-infarction * Stroke/TIA * Major vascular complication |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 30 Day Safety Endpoint Rates | 30 Days | Event rate for All-cause mortality, Cardiovascular mortality, Re-infarction, Stroke/TIA, Vascular complications, Worsening heart failure or hemodynamic compromise requiring inotropic or hemodynamic support post Impella explant, Repeat revascularization, Aortic valve injury or dysfunction, Renal failure, Hemolysis, Hematoma, Bleeding, Thrombocytopenia |
| Infarct Characteristics microvascular obstruction | 3-5 and 30 Days | Using CMR at 3-5 & 30 days, measurement of percent of microvascular obstruction (%MVO) |
| Infarct Characteristics - LV mass | 3 - 5 and 30 Days | Using CMR at 3-5 & 30 days, assessement of Infarct size as a percent of LV mass |
| Left Ventricular Function - Ejection Fraction | 3-5 and 30 Days | Using CMR at 3-5 & 30 days post PCI: assessment of Ejection fraction (EF) |
| Left Ventricular Function- LV end systolic and diastolic volume index | 3-5 and 30 Days | Using CMR imaging post PCI: assessment of LV end systolic and diastolic volume index (LVESVi & LVEDVi) |
| Infarct Characteristics - area at risk | 3 - 5 and 30 Days | Using CMR at 3-5 & 30 days, assessment of Infarct size as a percent of area (myocardium) at risk, |
Countries
United States
Outcome results
None listed