NCT03637205: ECLS-SHOCK

Extracorporeal Life Support in Cardiogenic Shock

Completed NA Last updated 13 December 2024

What this trial tests

NA trial testing ECLS insertion in Acute Myocardial Infarction in 420 participants. Completed in 2 September 2024.

Timeline

20 June 2019

Primary endpoint
23 December 2022

2 September 2024

Quick facts

Lead sponsor	Helios Health Institute GmbH
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	420
Start date	20 June 2019
Primary completion	23 December 2022
Estimated completion	2 September 2024
Sites	46 locations across Slovenia, Germany

Drugs / interventions tested

• ECLS insertion
• Revascularisation and optimal medical treatment

Conditions studied

• Acute Myocardial Infarction — all drugs for Acute Myocardial Infarction →
• Cardiogenic Shock — all drugs for Cardiogenic Shock →

Sponsor

Helios Health Institute GmbH

Who can join

Adults 18 to 75, any sex, with Acute Myocardial Infarction or Cardiogenic Shock. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

1. Extracorporeal Life Support in Infarct-Related Cardiogenic Shock.
   Thiele H, Zeymer U, Akin I, Behnes M, et al · · 2023 · cited 533× · PMID 37634145 · DOI 10.1056/nejmoa2307227
2. Unloading the Left Ventricle in Venoarterial ECMO: In Whom, When, and How?
   Ezad SM, Ryan M, Donker DW, Pappalardo F, et al · · 2023 · cited 120× · PMID 37068133 · DOI 10.1161/circulationaha.122.062371
3. Venoarterial extracorporeal membrane oxygenation or standard care in patients with cardiogenic shock complicating acute myocardial infarction: the multicentre, randomised EURO SHOCK trial.
   Banning AS, Sabaté M, Orban M, Gracey J, et al · · 2023 · cited 112× · PMID 37334659 · DOI 10.4244/eij-d-23-00204
4. Extracorporeal membrane oxygenation for cardiogenic shock: a meta-analysis of mortality and complications.
   Rajsic S, Treml B, Jadzic D, Breitkopf R, et al · · 2022 · cited 73× · PMID 36195759 · DOI 10.1186/s13613-022-01067-9
5. Management of cardiogenic shock.
   Thiele H, de Waha-Thiele S, Freund A, Zeymer U, et al · · 2021 · cited 70× · PMID 34413010 · DOI 10.4244/eij-d-20-01296
6. Effect of Moderate Hypothermia vs Normothermia on 30-Day Mortality in Patients With Cardiogenic Shock Receiving Venoarterial Extracorporeal Membrane Oxygenation: A Randomized Clinical Trial.
   Levy B, Girerd N, Amour J, Besnier E, et al · · 2022 · cited 63× · PMID 35103766 · DOI 10.1001/jama.2021.24776
7. Veno-arterial extracorporeal membrane oxygenation (ECMO) in patients with cardiogenic shock: rationale and design of the randomised, multicentre, open-label EURO SHOCK trial.
   Banning AS, Adriaenssens T, Berry C, Bogaerts K, et al · · 2021 · cited 57× · PMID 33106225 · DOI 10.4244/eij-d-20-01076
8. Prevention and treatment of pulmonary congestion in patients undergoing venoarterial extracorporeal membrane oxygenation for cardiogenic shock.
   Lüsebrink E, Orban M, Kupka D, Scherer C, et al · · 2020 · cited 51× · PMID 33099278 · DOI 10.1093/eurheartj/ehaa547