Door To Unloading With IMPELLA CP System in Acute Myocardial Infarction - Safety and Feasibility Study
- Conditions
- STEMI
- Interventions
- Device: Impella unloading prior to PPCI
- Registration Number
- NCT03000270
- Lead Sponsor
- Abiomed Inc.
- 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
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 50
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Prolonged unloading prior to PPCI Impella unloading prior to PPCI Activation of Impella CP for a 30 minute duration prior to primary percutaneous coronary intervention Immediate unloading prior to PPCI Impella unloading prior to PPCI Activation of Impella CP immediately prior to primary percutaneous coronary intervention
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method 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
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)
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,
Left Ventricular Function - Ejection Fraction 3-5 and 30 Days Using CMR at 3-5 \& 30 days post PCI: assessment of Ejection fraction (EF)
Trial Locations
- Locations (15)
Wellstar/Kennestone Hospital
🇺🇸Marietta, Georgia, United States
Hackensack Medical Center
🇺🇸Hackensack, New Jersey, United States
Northwell Health
🇺🇸Manhasset, New York, United States
Spectrum
🇺🇸Grand Rapids, Michigan, United States
Albert Einstein Medical Center
🇺🇸Philadelphia, Pennsylvania, United States
Advocate Edward Hospital
🇺🇸Oakbrook Terrace, Illinois, United States
University of Buffalo Hospital
🇺🇸Buffalo, New York, United States
Greenville Health System
🇺🇸Greenville, South Carolina, United States
West Virginia University Hospital
🇺🇸Morgantown, West Virginia, United States
Detroit Medical Center
🇺🇸Detroit, Illinois, United States
ABIOMED, Inc.
🇺🇸Danvers, Massachusetts, United States
Banner Good Samaritan Medical Center
🇺🇸Phoenix, Arizona, United States
Tufts Medical Center
🇺🇸Boston, Massachusetts, United States
Henry Ford Hospital
🇺🇸Detroit, Michigan, United States
Baystate Medical Center
🇺🇸Springfield, Massachusetts, United States