Extracorporeal Life Support in Cardiogenic Shock

Study Overview
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Brief Summary
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The aim of the study is to examine whether treatment with extracorporeal life support (ECLS) in addition to revascularization with percutaneous coronary intervention (PCI) or alternatively coronary artery bypass grafting (CABG) and optimal medical treatment is beneficial in comparison to no ECLS in patients with severe infarctrelated cardiogenic shock with respect to 30-day mortality

Official Title
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Prospective Randomized Multicenter Study Comparing Extracorporeal Life Support Plus Optimal Medical Care Versus Optimal Medical Care Alone in Patients With Acute Myocardial Infarction Complicated by Cardiogenic Shock Undergoing Revascularization

Conditions
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Acute Myocardial Infarction, Cardiogenic Shock

Intervention / Treatment
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* Procedure: ECLS insertion
* Other: Revascularisation and optimal medical treatment


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Cardiogenic shock complicating AMI (STEMI or NSTEMI) plus obligatory: Planned revascularization (PCI or alternatively CABG) Systolic blood pressure <90 mmHg >30 min or catecholamines required to maintain pressure >90 mmHg during Systole Signs of impaired organ perfusion with at least one of the following criteria a) Altered mental Status, b) Cold, clammy skin and extremities, c) Oliguria with urine output <30 ml/h Arterial lactate >3 mmol/l Informed consent Exclusion Criteria: Resuscitation >45 minutes Mechanical cause of cardiogenic shock Onset of shock >12 h Severe peripheral artery disease with impossibility to insert ECLS cannulae Age <18 years or age >75 years Shock of other cause (bradycardia, sepsis, hypovolemia, etc.) Other severe concomitant disease with limited life expectancy <6 months Pregnancy Participation in another trial

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 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
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: ECLS<br>PCI (or CABG) plus medical treatment + ECLS | Procedure: ECLS insertion<br>* After diagnostic angiography the culprit lesion should be identified and revascularization (preferably by PCI, alternatively CABG) should be planned. ECLS insertion should be performed preferably before revascularization<br>Other: Revascularisation and optimal medical treatment<br>* After diagnostic angiography the culprit lesion should be identified and revascularization (preferably by PCI, alternatively CABG) should be planned.<br>|
| Active Comparator: No ECLS<br>PCI (or CABG) plus medical treatment | Other: Revascularisation and optimal medical treatment<br>* After diagnostic angiography the culprit lesion should be identified and revascularization (preferably by PCI, alternatively CABG) should be planned.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 30-day mortality | 30-day all-cause death after randomization according to the intention-to-treat principle | 30 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to death within 6 and 12 months follow-up |  | 6 and 12 months | 
| Length of mechanical ventilation |  | 0 to 10 days | 
| Time to hemodynamic stabilization |  | 0 to 10 days | 
| Duration of catecholamine therapy |  | 0 to 10 days | 
| Serial creatinine-level and creatinine-clearance | Creatinine-clearance (Cockcroft-Gault-Formula) | 0 to 10 days from time of randomization until stabilization | 
| Length of ICU stay |  | 0 to 11 days | 
| Length of hospital stay |  | 0 to 14 days | 
| Serial SAPS-II score |  | 0 to 11 days | 
| Mean and area under the curve of arterial lactate |  | 0 to 14 days | 
| Acute renal failure requiring renal replacement therapy |  | 0 to 14 days | 
| Cerebral performance category (CPC) |  | 30 days, 6 and 12 months | 
| Cardiovascular mortality |  | 6 and 12 months | 
| Hospitalization for heart failure |  | 6 and 12 months | 
| Recurrent infarction |  | 30 days, 6 and 12 months | 
| Repeat revascularization (PCI or CABG) |  | 30 days, 6 and 12 months | 
| Status of Quality of life measured by EQ-5D-5L descriptive system | The EQ-5D-5L descriptive system comprises five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems and extreme problems expressed by 1-digit-numbers ranging from 1 (extreme problems) to 5 (no problems). The toal score ranges from 0-15 where 15 is the worst score. | 12 months | 
| Status of Quality of life measured by EQ VAS | The EuroQol Group visual analogue scale (EQ VAS) records the patient's self-rated health on a vertical visual analogue scale from 0 to 100, where the maximum 100 is labelled 'The best health you can imagine' and the minimum 0 is labelled 'The worst health you can imagine'. The VAS can be used as a quantitative measure of health outcome that reflect the patient's own judgement. | 12 months |