This study compares standard treatment plus Extra-Corporal Life Support (ECLS) versus standard treatment alone in patients with cardiogenic shock due to myocardial infarction.
Cardiogenic shock is a serious complication of a myocardial infarction. Despite optimal treatment the mortality in patients with cardiogenic shock still exceeds 50% and surviving patients mostly suffer from severe heart failure due to an impaired cardiac function. This study compares standard treatment plus Extra-Corporal Life Support (ECLS) versus standard treatment alone in patients with cardiogenic shock due to myocardial infarction. The main study hypothesis is to explore if additional treatment with ECLS preserves cardiac function (left ventricular ejection fraction) in patients with cardiogenic shock complicating acute myocardial infarction.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
42
Extra-Corporal Life Support (ECLS) (from Sorin)
University Hospital Munich
Munich, Bavaria, Germany
Left ventricular ejection fraction (LVEF) on day 30
Time frame: 30 days
30-day mortality
Time frame: 30 days
Lactate levels
Time frame: up to 48 hours
potentia hydrogenic levels
Time frame: 48 hours
Length of mechanical ventilation
Time frame: 30 days
Long-term mortality at 12 months
Time frame: up to 12 months
Length of ICU stay
Time frame: 30 days
Neurological Outcome (modified Rankin Scale)
Time frame: up to 12 months
MACE (defined as cardiac death, non-fatal myocardial re-infarction, rehospitalisation for cardiac reasons and the need of CABG or PCI)
Time frame: up to 12 months
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