Testing the Value of Novel Strategy and Its Cost Efficacy in Order to Improve the Poor Outcomes in Cardiogenic Shock

Summary

Cardiogenic shock (CGS) affects up to 10% of patients suffering acute coronary syndrome. It has a 30 day mortality of 45-50%. No pharmacological nor intervention/device trials have had any impact on this mortality in the last 20 years.

The EURO SHOCK Trial (supported by the European Union Horizons 2020 programme) will randomise 428 patients with CGS following acute coronary syndrome from 44 EU centres to early intervention with Extra Corporeal Membrane Oxygenation (ECMO) therapy or to standard treatment (with no ECMO). This intervention is a high cost specialist centre procedure that warrants further investigation including economic appraisal. Multiple mechanistic and hypothesis generating sub-studies will be undertaken.

Conditions

• Cardiogenic Shock

Interventions

PROCEDURE

Percutaneous coronary intervention (PCI)

Primary PCI or early/immediate PCI for NSTEMI will be undertaken according to recommended Guideline standards of care. This will include appropriate pre-loading with dual anti-platelet therapy, a preferred radial approach, intra-procedural anti-coagulation (with measure of ACT if considered appropriate every 30 minutes) and the use of drug eluting stents. Treatment will be delivered essentially to the culprit vessel only. A successful procedure will be one considered to have achieved TIMI 2-3 flow and residual stenosis \< 50%. PCI failure will not be an exclusion itself from the trial.

OTHER

Pharmacological Support

Use of pharmacological agents (Norepinephrine, Dobutamine, Levosimendan) according to ESC Guidelines to maintain mean arterial pressure \>75 mmHg in accordance with recognised standards of care. Changes in pharmacotherapy will NOT be regarded as escalation therapy. However the number of and dose of inotropes will be documented in the CRF.

DEVICE

VA-ECMO

Following PCI of the culprit lesion, patients will have ECMO initiated as soon as echocardiography (to exclude mechanical causes) has been completed, once they have been assessed as having failed to improve (with the aim to start ECMO as early as possible from 30 mins after completed P-PCI procedure ad fully established within 6 hours after randomisation). Peripheral Veno-arterial ECMO will be employed with a flow rate according to individual patient needs. Other methods of LV unloading, distal limb perfusion, maintenance of ejection/aortic valve opening and anti-coagulation will be instituted as per sites' usual care. A minimum 24 hours be allocated to the randomised therapy in order that strategy failure is demonstrated but this will be at the physicians' discretion.

Sponsors & Collaborators

• European Commission

  collaborator OTHER

• University of Glasgow

  collaborator OTHER

• KU Leuven

  collaborator OTHER

• University of East Anglia

  collaborator OTHER

• Deutsches Herzzentrum Muenchen

  collaborator OTHER

• A.O. Ospedale Papa Giovanni XXIII

  collaborator OTHER

• Chalice Medical Ltd

  collaborator UNKNOWN

• Ludwig-Maximilians - University of Munich

  collaborator OTHER

• University of Tromso

  collaborator OTHER

• Institut d'Investigacions Biomèdiques August Pi i Sunyer

  collaborator OTHER

• Paula Stradina Liniska Universitates

  collaborator UNKNOWN

• Accelopment AG

  collaborator OTHER

• Universiteit Antwerpen

  collaborator OTHER

• European Cardiovascular Research Center

  collaborator NETWORK

• University of Leicester

  lead OTHER

Principal Investigators

• Anthony H Gershlick · University of Leicester

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

90 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2019-10-11

Primary Completion

2023-03-03

Completion

2024-02-01

Countries

• Austria
• Belgium
• Germany
• Italy
• Latvia
• Norway
• Spain
• United Kingdom

Study Locations