Randomized Clinical Study of Extra-Corporal Life Support in Cardiogenic Shock Complicating Acute Myocardial Infarction
Trial Snapshot
- Phase
- Phase 4
- Status
- Completed
- Sponsor
- Enrollment
- 42
- Locations
- 2
- Primary Endpoint
- Left ventricular ejection fraction (LVEF) on day 30
Study Overview
Brief Summary
This study compares standard treatment plus Extra-Corporal Life Support (ECLS) versus standard treatment alone in patients with cardiogenic shock due to myocardial infarction.
Detailed Description
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 Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 80 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Cardiogenic shock complicating acute myocardial (STEMI or NSTEMI) with
- •intended revascularization (PCI or CABG)
- •Systolic blood pressure < 90 mmHg > 30 min or inotropes required to maintain pressure > 90 mmHg during systole
- •Signs of left heart insufficiency and pulmonary congestion
- •Signs of impaired organ perfusion with at least one of the following:
- •Altered mental status
- •Cold, clammy skin
- •Urine output <30 ml/h
- •Serum lactate >2mmol/l
- •Informed consent
Exclusion Criteria
- •Resuscitation > 60 minutes, ischemia > 10 minutes
- •No intrinsic heart action
- •Cerebral deficit with fixed dilated pupils
- •Mechanical infarction complication
- •Onset of shock > 12 h
- •Severe peripheral artery disease
- •Aortic regurgitation > II.°
- •Age > 80 years
- •shock of other cause
- •Other severe concomitant disease
- •participation in another trial
Arms & Interventions
Extra-Corporal Life Support (ECLS)
Standard treatment plus Extra-Corporal Life Support (ECLS) (from Sorin) in patients with cardiogenic shock due to myocardial infarction.
Intervention: Extra-Corporal Life Support (ECLS) (Device)
Standard treatment
Standard treatment alone without Extra-Corporal Life Support (ECLS) in patients with cardiogenic shock due to myocardial infarction.
Outcomes
Primary Outcomes
Left ventricular ejection fraction (LVEF) on day 30
Time Frame: 30 days
Secondary Outcomes
- potentia hydrogenic levels(48 hours)
- Length of ICU stay(30 days)
- 30-day mortality(30 days)
- Long-term mortality at 12 months(up to 12 months)
- Neurological Outcome (modified Rankin Scale)(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)(up to 12 months)
- Lactate levels(up to 48 hours)
- Length of mechanical ventilation(30 days)
Investigators
PD Dr. Stefan Brunner
PD Dr. med.
LMU Klinikum