Clinical Study of Extra-Corporal Life Support in Cardiogenic Shock Complicating Acute Myocardial Infarction

Study Overview
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Brief Summary
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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
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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.

Official Title
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Randomized Clinical Study of Extra-Corporal Life Support in Cardiogenic Shock Complicating Acute Myocardial Infarction

Conditions
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Cardiogenic Shock

Intervention / Treatment
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* Device: Extra-Corporal Life Support (ECLS)


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Best medical therapy versus best medical therapy + ECLS in the treatment of cardiogenic shock complicating acute myocardial infarction
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Extra-Corporal Life Support (ECLS)<br>Standard treatment plus Extra-Corporal Life Support (ECLS) (from Sorin) in patients with cardiogenic shock due to myocardial infarction. | Device: Extra-Corporal Life Support (ECLS)<br>* Extra-Corporal Life Support (ECLS) (from Sorin)<br>|
| No Intervention: Standard treatment<br>Standard treatment alone without Extra-Corporal Life Support (ECLS) in patients with cardiogenic shock due to myocardial infarction. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Left ventricular ejection fraction (LVEF) on day 30 |  | 30 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 30-day mortality |  | 30 days | 
| Lactate levels |  | up to 48 hours | 
| potentia hydrogenic levels |  | 48 hours | 
| Length of mechanical ventilation |  | 30 days | 
| Long-term mortality at 12 months |  | up to 12 months | 
| Length of ICU stay |  | 30 days | 
| 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 |