Testing the Value of Novel Strategy and Its Cost Efficacy in Order to Improve the Poor Outcomes in Cardiogenic Shock
EUROSHOCK
EURO SHOCK Testing the Value of Novel Strategy and Its Cost Efficacy in Order to Improve the Poor Outcomes in Cardiogenic Shock
1 other identifier
interventional
428
8 countries
47
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Oct 2019
Longer than P75 for not_applicable
47 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 19, 2018
CompletedFirst Posted
Study publicly available on registry
January 23, 2019
CompletedStudy Start
First participant enrolled
October 11, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 3, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2024
CompletedMay 3, 2021
April 1, 2021
3.4 years
December 19, 2018
April 29, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
All-cause mortality at 30 days
Death from any cause
at 30 days
Secondary Outcomes (3)
All-cause mortality or admission for heart failure at 12 months
at 12 months
All-cause mortality at 12 months
at 12 months
Admission for heart failure at 12 months
at 12 months
Other Outcomes (19)
All-cause mortality
From date of index hospital admission to date of discharge from hospital, assessed up to 12 months.
Cardiovascular mortality
From date of index hospital admission to date of discharge from hospital, assessed up to 12 months.
Stroke.
From date of index hospital admission to date of discharge from hospital, assessed up to 12 months
- +16 more other outcomes
Study Arms (2)
Immediate PCI with medical therapy
ACTIVE COMPARATORGroup 1 will receive immediate revascularisation with Percutaneous Coronary Intervention (PCI) to the culpirit lesion only) + standard care (pharmacological support titrated to attain SBP \>90mmHg). No mechanical support device allowed.
Immediate PCI with early VA-ECMO
EXPERIMENTALGroup 2 will receive immediate PCI plus standard pharmacological support with early peripheral veno-arterial ECMO.
Interventions
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.
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.
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.
Eligibility Criteria
You may qualify if:
- Willing to provide informed consent/assent.
- Presentation CGS within 24 hours of onset of Acute Coronary Syndrome (ACS) symptoms.
- CGS can only be secondary to ACS (Type 1 MI STEMI or N-STEMI) or secondary to ACS following previous recent PCI (acute/sub-acute stent thrombosis ARC)
- PCI has been attempted.
- Persistence of CGS 30 minutes after successful or unsuccessful revascularisation of culprit coronary artery to allow for echocardiography and clinical assessment.
- CGS will be defined by the following 2 criteria:
- Systolic blood pressure \<90 mmHg for at least 30 minutes, or a requirement for a continuous infusion of vasopressor or inotropic therapy to maintain systolic blood pressure \> 90 mmHg.
- Clinical signs of pulmonary congestion, plus signs of impaired organ perfusion with at least one of the following manifestations:
- altered mental status.
- cold and clammy skin and limbs.
- oliguria with a urine output of less than 30 ml per hour.
- elevated arterial lactate level of \>2.0 mmol per litre.
- Provision of informed assent followed by patient consent; \[or relative or physician consent if the patient is unable to consent\].
You may not qualify if:
- Unwilling to provide informed assent/consent.
- Echocardiographic evidence) of mechanical cause for CGS: eg ventricular septal defect, LV-free wall rupture, ischaemic mitral regurgitation (recorded within 30 mins of end of PCI procedure).
- Age \<18 and\>90 years.
- Deemed appropriately frail (≥ 5 Canadian frailty score)
- Shock from another cause (sepsis, haemorrhagic/hypovolaemic shock, anaphylaxis, myocarditis etc.).
- Significant systemic illness
- Known dementia of any severity.
- Comorbidity with life expectancy \<12 months.
- Severe peripheral vascular disease (precluding access making ECMO contra- indicated).
- Severe allergy or intolerance to pharmacological or antithrombotic anti-platelet agents.
- Out-of-hospital cardiac arrest (OHCA) under any of the following circumstances:-
- without return of spontaneous circulation (ongoing resuscitation effort).
- without pH or \>7 without bystander CPR within 10 minutes of collapse.
- Involved in another randomised research trial within the last 12 months.
- Arterial lactate level of \<2.0 mmol per litre.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of Leicesterlead
- European Commissioncollaborator
- University of Glasgowcollaborator
- KU Leuvencollaborator
- University of East Angliacollaborator
- Deutsches Herzzentrum Muenchencollaborator
- A.O. Ospedale Papa Giovanni XXIIIcollaborator
- Chalice Medical Ltdcollaborator
- Ludwig-Maximilians - University of Munichcollaborator
- University of Tromsocollaborator
- Institut d'Investigacions Biomèdiques August Pi i Sunyercollaborator
- Paula Stradina Liniska Universitatescollaborator
- Accelopment AGcollaborator
- Universiteit Antwerpencollaborator
- European Cardiovascular Research Centercollaborator
Study Sites (47)
Medical University of Vienna
Vienna, Vienna, 1090, Austria
Algemeen Stedelijk Ziekenhuis Aalst
Aalst, 9300, Belgium
Onze Lieve Vrouw Hospital Aalst
Aalst, 9300, Belgium
University Hospital Antwerpen
Antwerp, 2610, Belgium
ZNA Middelheim
Antwerp, 2610, Belgium
Imelda Hospital Bonheiden
Bonheiden, 2820, Belgium
AZ Monica
Deurne, 2100, Belgium
AZ Gent
Ghent, 9000, Belgium
Jessa Ziekenhuis Hasselt
Hasselt, 3500, Belgium
Katholieke Universiteit Leuven
Leuven, 3000, Belgium
AZ Turnhout
Turnhout, 2300, Belgium
Universitäts-Herzzentrum Freiburg-Bad Krozingen
Bad Krozingen, 79189, Germany
Segeberger Kliniken GmbH
Bad Segeberg, 23795, Germany
Herz-Zentrum Bodensee
Konstanz, 78464, Germany
Klinikum Rechts Der Isar
Munich, 81675, Germany
Klinikum Campus Innenstadt
München, 80336, Germany
Deutsches Herzzentrum München
München, 80636, Germany
Barmherzige Brüder gemeinnützige Krankenhaus GmbH
München, 80639, Germany
Klinik Augustinum
München, 81375, Germany
Ludwig-Maximilians-Universität München
München, 81377 Munich, Germany
Uniklinikum Tübingen
Tübingen, 72076, Germany
Azienda Ospedalierea Papa Giovanni XXIII
Bergamo, 24127, Italy
University Hospital of Bologna Policlinico S. Orsola - Malpighi
Bologna, 40138, Italy
Azienda Universitaria Ospedaliera Careggi, Firenze
Florence, 50134, Italy
Università degli Studi di Padova
Padua, 35128, Italy
Ospedale San Giovanni Bosco di Torino
Torino, 10154, Italy
Paula Stradina Liniska Universitates Slimnica AS
Riga, 1002, Latvia
The Nordland Hospital
Bodø, 8092, Norway
The Finnmark Hospital
Hammerfest, 9601, Norway
The Helgeland Hospital
Mo i Rana, 8607, Norway
Universitetet i Tromsoe
Tromsø, 9019, Norway
Hospital Germans Trias I Pujol
Badalona, 08916, Spain
Hospital Vall d'Hebron
Barcelona, 08035, Spain
Consorci Institut D'Investicacions Biomediques August Pi i Sunyer / Hospital Clinic de Barcelona
Barcelona, 08036, Spain
Hospital de Sant Pau
Barcelona, 08041, Spain
Hospital de Bellvitge
Barcelona, 08907, Spain
University Hospital Leicester
Leicester, East Midlands, LE3 9QP, United Kingdom
Hairmyres Hospital
Airdrie, Lanarkshire, ML6 0JS, United Kingdom
University of Leicester
Leicester, Leicestershire, LE39QP, United Kingdom
Newcastle Freeman Hospital
Newcastle, Newcastle Upon Tyne, NE2 4HH, United Kingdom
University of Glasgow
Glasgow, Scotland, G12 8QQ, United Kingdom
Papworth Hospital
Cambridge, CB23 3RE, United Kingdom
Golden Jubilee National Hospital
Glasgow, G81 4SA, United Kingdom
St Barts and the London Hospital
London, EC1M 6BQ, United Kingdom
Kings College Hospital
London, SE1 2PR, United Kingdom
Harefield and Brompton London
London, SW3 6NP, United Kingdom
Guys and St Thomas NHS Foundation Trust
London, United Kingdom
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Anthony H Gershlick
University of Leicester
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 19, 2018
First Posted
January 23, 2019
Study Start
October 11, 2019
Primary Completion
March 3, 2023
Study Completion
February 1, 2024
Last Updated
May 3, 2021
Record last verified: 2021-04
Data Sharing
- IPD Sharing
- Will not share