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

Helios Health Institute GmbH46 sites in 2 countries420 target enrollmentJune 20, 2019

ConditionsAcute Myocardial Infarction Cardiogenic Shock

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Acute Myocardial Infarction
Sponsor: Helios Health Institute GmbH
Enrollment: 420
Locations: 46
Primary Endpoint: 30-day mortality
Status: Completed
Last Updated: last year

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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

Registry

clinicaltrials.gov

Start Date

June 20, 2019

End Date

September 2, 2024

Last Updated

last year

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Helios Health Institute GmbH

Responsible Party

Sponsor

Eligibility Criteria

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

Outcomes

Primary Outcomes

30-day mortality

Time Frame: 30 days

30-day all-cause death after randomization according to the intention-to-treat principle

Secondary Outcomes

Length of ICU stay(0 to 11 days)
Length of hospital stay(0 to 14 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)
Hospitalization for heart failure(6 and 12 months)
Time to death within 6 and 12 months follow-up(6 and 12 months)
Serial creatinine-level and creatinine-clearance(0 to 10 days from time of randomization until stabilization)
Serial SAPS-II score(0 to 11 days)
Status of Quality of life measured by EQ VAS(12 months)
Time to hemodynamic stabilization(0 to 10 days)
Length of mechanical ventilation(0 to 10 days)
Cerebral performance category (CPC)(30 days, 6 and 12 months)
Recurrent infarction(30 days, 6 and 12 months)
Duration of catecholamine therapy(0 to 10 days)
Cardiovascular mortality(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(12 months)