Trial DesignsExtracorporeal life support in patients with acute myocardial infarction complicated by cardiogenic shock - Design and rationale of the ECLS-SHOCK trial
Section snippets
Study objectives
The ECLS-SHOCK trial is a prospective, randomized, international, multicenter, open-label trial in patients with acute myocardial infarction including ST- and non-ST-elevation myocardial infarction (STEMI and NSTEMI) complicated by severe CS (Figure 1).
It will determine if the use of ECLS in addition to early revascularization is superior to early revascularization alone (with potential escalation to other MCS devices if necessary).
The trial is registered under www.clinicaltrials.gov:NCT03637205
Discussion
Current guidelines recommend the use of short-term MCS in refractory CS and in selected patients. Based on this recommendation, active MCS – excluding IABP - are currently used in approximately 10% of patients presenting with CS,8,11 although data derived from large-scale randomized clinical trials to assess their benefit/harm are still missing. The few published studies assessing the use of Impella are too small to draw meaningful conclusions with regard to clinical endpoints such as
Summary
At present, a relevant group of patients with acute myocardial infarction complicated by CS receives MCS such as ECLS for stabilization. However, prospective randomized data on the benefit of ECLS are lacking and current guidelines base their recommendation of using ECLS in refractory CS primarily on expert opinions.
The ECLS-SHOCK trial has been designed to test the hypothesis that in patients with severe CS complicating acute myocardial infarction ECLS use in addition to revascularization will
Funding source
Else Kröner Fresenius Foundation, German Heart Research Foundation, Leipzig Heart Institute
Acknowledgment
Funding: Else Kröner Fresenius Foundation: Grant number: 2018_A102, German Heart Research Foundation: Grant number: F/10/18, Leipzig Heart Institute: Grant number: None
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Clinicaltrials.gov: NCT03637205
- 1
The first three authors should be considered as first authors.
- 2
The last two authors should be considered as senior authors.