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
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
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
50
Impella unloading prior to PPCI
Banner Good Samaritan Medical Center
Phoenix, Arizona, United States
Wellstar/Kennestone Hospital
Marietta, Georgia, United States
Detroit Medical Center
Infarct size at 30 Days
Assessment of infarct size as percent of left ventricular (LV) mass, evaluated using CMR, at 30 days post-PPCI
Time frame: 30 Days
MACCE at 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
Time frame: 30 Days
Infarct Characteristics - LV mass
Using CMR at 3-5 \& 30 days, assessement of Infarct size as a percent of LV mass
Time frame: 3 - 5 and 30 Days
Infarct Characteristics - area at risk
Using CMR at 3-5 \& 30 days, assessment of Infarct size as a percent of area (myocardium) at risk,
Time frame: 3 - 5 and 30 Days
30 Day Safety Endpoint Rates
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
Time frame: 30 Days
Infarct Characteristics microvascular obstruction
Using CMR at 3-5 \& 30 days, measurement of percent of microvascular obstruction (%MVO)
Time frame: 3-5 and 30 Days
Left Ventricular Function- LV end systolic and diastolic volume index
Using CMR imaging post PCI: assessment of LV end systolic and diastolic volume index (LVESVi \& LVEDVi)
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Detroit, Illinois, United States
Advocate Edward Hospital
Oakbrook Terrace, Illinois, United States
Tufts Medical Center
Boston, Massachusetts, United States
ABIOMED, Inc.
Danvers, Massachusetts, United States
Baystate Medical Center
Springfield, Massachusetts, United States
Henry Ford Hospital
Detroit, Michigan, United States
Spectrum
Grand Rapids, Michigan, United States
Hackensack Medical Center
Hackensack, New Jersey, United States
...and 5 more locations
Time frame: 3-5 and 30 Days
Left Ventricular Function - Ejection Fraction
Using CMR at 3-5 \& 30 days post PCI: assessment of Ejection fraction (EF)
Time frame: 3-5 and 30 Days