Acute Myocardial Infarction, Cardiogenic Shock
Conditions
Brief summary
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
Interventions
PROCEDUREECLS insertion
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
OTHERRevascularisation and optimal medical treatment
After diagnostic angiography the culprit lesion should be identified and revascularization (preferably by PCI, alternatively CABG) should be planned.
Sponsors
Heart Center Leipzig - University Hospital
IHF GmbH - Institut für Herzinfarktforschung
Helios Health Institute GmbH
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 30-day mortality | 30 days | 30-day all-cause death after randomization according to the intention-to-treat principle |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Recurrent infarction | 30 days, 6 and 12 months | — |
| Repeat revascularization (PCI or CABG) | 30 days, 6 and 12 months | — |
| 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 | 0 to 10 days from time of randomization until stabilization | Creatinine-clearance (Cockcroft-Gault-Formula) |
| Length of ICU stay | 0 to 11 days | — |
| Hospitalization for heart failure | 6 and 12 months | — |
| 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 | — |
| Status of Quality of life measured by EQ-5D-5L descriptive system | 12 months | 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. |
| Status of Quality of life measured by EQ VAS | 12 months | 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. |
| Length of hospital stay | 0 to 14 days | — |
Countries
Germany, Slovenia
Outcome results
None listed