NCT03637205

Extracorporeal Life Support in Cardiogenic Shock

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 420 (actual)
• Sponsor: Helios Health Institute GmbH · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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

Conditions

• Acute Myocardial Infarction
• Cardiogenic Shock

Interventions

Type	Name	Description
PROCEDURE	ECLS 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
OTHER	Revascularisation and optimal medical treatment	After diagnostic angiography the culprit lesion should be identified and revascularization (preferably by PCI, alternatively CABG) should be planned.

Timeline

• Start date: 2019-06-20
• Primary completion: 2022-12-23
• Completion: 2024-09-02
• First posted: 2018-08-17
• Last updated: 2024-12-13

Locations

46 sites across 2 countries: Germany, Slovenia