Cardiogenic ShockEUROSHOCKNCT03813134
Testing the Value of Novel Strategy and Its Cost Efficacy in Order to Improve the Poor Outcomes in Cardiogenic Shock
A study testing Percutaneous coronary intervention (PCI), Pharmacological Support and VA-ECMO in people with Cardiogenic Shock, run by University of Leicester at 47 sites in 8 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Cardiogenic Shock
- What is being tested?
- Percutaneous coronary intervention (PCI), Pharmacological Support and VA-ECMO
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 428 participants
- Where
- 47 sitesin 8 countries
- Study dates
- 11 Oct 2019to 1 Feb 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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:
Show all 13Show fewer
- 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].
Who cannot join
- 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
Show all 15Show fewer
- 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.
Trial locations and contacts
47 sites in 8 countries.
47 sites in 8 countries
United Kingdom11 sites, 11 recruiting
- Not yet recruiting
Hairmyres Hospital
Airdrie, Lanarkshire, ML6 0JS
Raymond Hamill, +441236712460, raymond.hamill@lanarkshire.scot.nhs.uk
- Not yet recruiting
Papworth Hospital
Cambridge, CB23 3RE
Alain Vuylsteke, +4401480364381, a.vuylsteke@nhs.net
- Not yet recruiting
University of Glasgow
Glasgow, Scotland, G12 8QQ
Colin Berry, +441413301671, colin.berry@glasgow.ac.uk
- Not yet recruiting
Golden Jubilee National Hospital
Glasgow, G81 4SA
Catherine Sinclair, +44141 951 5440, catherine.sinclair@gjnh.scot.nhs.uk
- Not yet recruiting
University Hospital Leicester
Leicester, East Midlands, LE3 9QP
Hakeem Yusuff, 01162502315, hakeem.yusuff@uhl-tr.nhs.uk
- Recruiting
University of Leicester
Leicester, Leicestershire, LE39QP
Anthony H Gershlick, MBBS, FRCP, 0116 256 3887, ahg8@le.ac.uk
Saeeda M Bashir, 07568591629, saeeda.bashir@leicester.ac.uk
- Not yet recruiting
St Barts and the London Hospital
London, EC1M 6BQ
Andreas Baumbach, +42078823909, baumbach.andreas@nhs.net
- Recruiting
Kings College Hospital
London, SE1 2PR
Jonathan Hill, +442032995675, jmhill@nhs.net
- Recruiting
Harefield and Brompton London
London, SW3 6NP
Richard Trimlett, +442073528121, R.Trimlett@rbht.nhs.uk
- Not yet recruiting
Guys and St Thomas NHS Foundation Trust
London
Nicholas Barrett, Nicholas.Barrett@gstt.nhs.uk
- Not yet recruiting
Newcastle Freeman Hospital
Newcastle, Newcastle Upon Tyne, NE2 4HH
Vijay Kunadian, +441912085797, vijay.kunadian@newcastle.ac.uk
Belgium10 sites, 10 recruiting
- Not yet recruiting
Algemeen Stedelijk Ziekenhuis Aalst
Aalst, 9300
Ian Buysschaert, +3253766730, ian.buysschaert@me.com
- Not yet recruiting
Onze Lieve Vrouw Hospital Aalst
Aalst, 9300
Herbert De Raedt, +32537244 33, herbert.de.raedt@olvz-aalst.be
- Not yet recruiting
University Hospital Antwerpen
Antwerp, 2610
Steven Haine, +3238214281, steven.haine@uza.be
- Not yet recruiting
ZNA Middelheim
Antwerp, 2610
Paul Vermeersch, +3232803211, Paul.vermeersch@zna.be
- Not yet recruiting
Imelda Hospital Bonheiden
Bonheiden, 2820
William DeWilde, +3215505011, willemdewilde@yahoo.com
- Not yet recruiting
AZ Monica
Deurne, 2100
Guy Lenders, +3233205816, Guy.lenders@gmail.com
- Not yet recruiting
AZ Gent
Ghent, 9000
Michel De Pauw, +3293323460, Michel.depauw@uzgent.be
- Not yet recruiting
Jessa Ziekenhuis Hasselt
Hasselt, 3500
Philippe Timmermans, +3211337023, philippe.timmermans@uzleuven.be
- Recruiting
Katholieke Universiteit Leuven
Leuven, 3000
Tom Adriaenssens, +3216344235, tom.adriaenssens@uzleuven.be
- Not yet recruiting
AZ Turnhout
Turnhout, 2300
Mark Coosem, +3214406461, markcoosemans@me.com
Germany10 sites, 10 recruiting
- Not yet recruiting
Universitäts-Herzzentrum Freiburg-Bad Krozingen
Bad Krozingen, 79189
Franz-Josef Neumann, +498917973701, Franz-Josef.Neumann@universitaets-herzzentrum.de
- Not yet recruiting
Segeberger Kliniken GmbH
Bad Segeberg, 23795
Gert Richardt, +49-4551-8024807, gert.richardt@segebergerkliniken.de
- Not yet recruiting
Herz-Zentrum Bodensee
Konstanz, 78464
Klaus Tiroch, +497531897195, Klaus.Tiroch@herz-zentrum.com
- Recruiting
Klinikum Campus Innenstadt
München, 80336
Axel Bauer, +4989440052381, Axel.Bauer@med.uni-muenchen.de
- Recruiting
Deutsches Herzzentrum München
München, 80636
Adnan Kastrati, +498912184578, kastrati@dhm.mhn.de
- Not yet recruiting
Barmherzige Brüder gemeinnützige Krankenhaus GmbH
München, 80639
Roland Schmidt, +49-89-17973701, Roland.Schmidt@Barmherzige-Muenchen.de
- Not yet recruiting
Klinik Augustinum
München, 81375
Christian Hagl, +4989440072950, Christian.Hagl@med.uni-muenchen.de
- Recruiting
Ludwig-Maximilians-Universität München
München, 81377 Munich
Steffen Massberg, +4989440076074, steffen.massberg@med.uni-muenchen.de
- Not yet recruiting
Klinikum Rechts Der Isar
Munich, 81675
Tareq Ibrahim, +498941405994, t.ibrahim@lrz.tu-muenchen.de
- Not yet recruiting
Uniklinikum Tübingen
Tübingen, 72076
Christian Schlensak, +4970712986638, christian.schlensak@med.uni-tuebingen.de
Italy5 sites, 5 recruiting
- Not yet recruiting
Azienda Ospedalierea Papa Giovanni XXIII
Bergamo, 24127
Giulio Guagliumi, +390352673452, guagliumig@gmail.com
- Not yet recruiting
University Hospital of Bologna Policlinico S. Orsola - Malpighi
Bologna, 40138
Francesco Saia, +39512144475, francescosaia@hotmail.com
- Not yet recruiting
Azienda Universitaria Ospedaliera Careggi, Firenze
Florence, 50134
Carlo DiMario, +3955794111, carlo.dimario@unifi.it
- Not yet recruiting
Università degli Studi di Padova
Padova, 35128
Giuseppe Tarantini, +390498212586, giuseppe.tarantini.1@gmail.com
- Not yet recruiting
Ospedale San Giovanni Bosco di Torino
Torino, 10154
Roberto Garbo, +39112402418, r.garbo68@gmail.com
Spain5 sites, 5 recruiting
- Recruiting
Hospital Germans Trias I Pujol
Badalona, 08916
Fina Mauri, +34934978989, mauritri@gmail.com
- Recruiting
Hospital Vall d'Hebron
Barcelona, 08035
Bruno Garcia del Blanco, +34932274835, brunogb51@gmail.com
- Recruiting
Consorci Institut D'Investicacions Biomediques August Pi i Sunyer / Hospital Clinic de Barcelona
Barcelona, 08036
Manel Sabate, +34606447666, masabate@clinic.cat
- Not yet recruiting
Hospital de Sant Pau
Barcelona, 08041
Antonio Serra, +34935565775, ASerraP@santpau.cat
- Recruiting
Hospital de Bellvitge
Barcelona, 08907
Angel Cequier, +34932607686, acequier@bellvitgehospital.cat
Norway4 sites, 4 recruiting
- Not yet recruiting
The Nordland Hospital
Bodø, 8092
Knut Tore Lappegård, +4775534000, knut.tore.lappegard@nordlandssykehuset.no
- Not yet recruiting
The Finnmark Hospital
Hammerfest, 9601
Bjørn Wembstad, +4778421000, bjorn.wembstad@finnmarkssykehuset.no
- Not yet recruiting
The Helgeland Hospital
Mo i Rana, 8607
Bjørn Haug, +4775065272, bjorn.haug@helgelandssykehuset.no
- Recruiting
Universitetet i Tromsoe
Tromsø, 9019
Truls Myrmel, +4777626612, truls.myrmel@uit.no
Austria1 site, 1 recruiting
- Not yet recruiting
Medical University of Vienna
Vienna, State of Vienna, 1090
Christian Hengstenberg, +4314040046140, christian.hengstenberg@meduniwien.ac.at
Latvia1 site, 1 recruiting
- Recruiting
Paula Stradina Liniska Universitates Slimnica AS
Riga, 1002
Andrejs Erglis, +37167452015, a.a.erglis@stradini.lv
About this study
Official title: EURO SHOCK Testing the Value of Novel Strategy and Its Cost Efficacy in Order to Improve the Poor Outcomes in Cardiogenic Shock
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.
Read the detailed description
The EURO SHOCK trial tests the novel use of early deployment of mechanical support device in Cardiogenic Shock (CGS) in a randomised, strategy trial, with evidence of benefit or otherwise measured by recording hard clinical end-point outcomes.
Extra Corporeal Membrane Oxygenation (ECMO) is already used in CGS. This is therefore not a novel therapy. It is the use of ECMO early in the development of CGS that is the novel aspect of this project. The Investigators will test whether a strategy of very early ECMO can ameliorate the rapid decline that many CGS patients suffer. The value of deploying a clinically used and approved device prospectively and early in the natural history of CGS compared to standard practice has not been tested before and will be the basis of the EURO SHOCK project.
This trial itself will be a prospective randomized, open label, design study that will compare two groups of patients: Both will receive appropriate percutaneous coronary intervention (PCI) as is current practice as they arrive at the hospital.
- Group 1 will receive immediate PCI + standard care (pharmacological support).
- Group 2 will receive immediate PCI plus support with early peripheral veno-arterial ECMO + standard care (pharmacological support).
The Investigators will also compare the cost-effectiveness of early VA-ECMO, as compared to current standard of care. EURO SHOCK will also evaluate novel CMR protocols in these unwell patients, and also whether systems of urgent flagged transfer of the unwell patient is practical and beneficial. The Investigators will determine whether there are biological and ECG markers that predict worse patient outcomes, which could thus help select most appropriate patients for expedited treatments (the patient is only transferred if needed).
Although at the centre of the project there is a randomised trial, other important objectives will therefore be delivered.
The research study will additionally focus, through a-priori, post-hoc analyses, on higher risk and vulnerable sub groups such as the elderly (>75 years) and females, the importance of site of infarct and on those with multi-morbidities such as diabetes. These post-hoc data will be published separately.
The trial will include patients with out of hospital cardiac arrest (OHCA) who have documented return of spontaneous circulation (ROSC) but with certain caveats (see exclusion criteria).
The primary outcome is the all-cause mortality at 30 days following admission with acute coronary syndrome with cardiogenic shock. Key secondary outcomes will include all- cause mortality or admission with heart failure at 12 months, all-cause mortality at 12 months and admission to hospital with heart failure at 12 months.
A cornerstone of this research programme will be to determine the cost-efficacy of ECMO in this setting. Cost benefit will be measured both immediately and in the longer term testing for example any impact of need for heart failure therapies. This will be undertaken with evaluations of the cost-effectiveness of the device and evaluation of quality of life using the EuroQuol-5D-5L and the Minnesota Living with Heart Failure Questionnaire.
The EUROSHOCK trial will also include the following sub-studies:
- Cardiovascular MRI: Cardio-Renal Imaging Sub-study using novel shortened, non-breath-holding protocols.
- Platelet Function Sub-study designed to access the impact of novel ECMO coatings on platelet activation.
The programme will be developed and run through a carefully thought through management structure comprising 8 separate but interlinked work programmes (each targeted at one aspect of the project and headed by an experienced clinical trialist or trial manager) and involve the dissemination of results through a designated dissemination work package. Attention to translating the results to subsequent on-the-ground patient care will be an important aim for the management and dissemination team, and will involve patient support groups, professional societies and information delivered directly to the medical and non- medical staff caring for CGS patients.
- Conditions
- Cardiogenic Shock
- Being tested
- Percutaneous coronary intervention (PCI), Pharmacological Support, VA-ECMO
- Keywords
- Cardiogenic Shock, Acute Myocardial Infarction, Acute Coronary Syndrome
- Medical subject headings
- Shock, Cardiogenic, Acute Coronary Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Percutaneous coronary intervention (PCI)Procedure or surgery
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.
Pharmacological SupportOther
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.
VA-ECMODevice
Also called Veno-Arterial Extra Corporeal Membrane Oxygenation.
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.
| Study group | Role | What they receive |
|---|---|---|
| Immediate PCI with medical therapy | Active comparator | Group 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. Receives: Procedure: Percutaneous coronary intervention (PCI); Other: Pharmacological Support |
| Immediate PCI with early VA-ECMO | Experimental | Group 2 will receive immediate PCI plus standard pharmacological support with early peripheral veno-arterial ECMO. Receives: Procedure: Percutaneous coronary intervention (PCI); Other: Pharmacological Support; Device: VA-ECMO |
What is being measured
The primary outcome is the main question the study is designed to answer.
All-cause mortality at 30 days
Death from any cause
Measured: at 30 days
Secondary outcomes (3)
All-cause mortality or admission for heart failure at 12 months
Death from any cause, or admission to hospital for heart failure with typical symptoms (e.g. breathlessness, ankle swelling and fatigue) that may be accompanied by signs (e.g. elevated jugular venous pressure, pulmonary crackles and peripheral oedema) caused by a structural and/or functional cardiac abnormality, resulting in a reduced cardiac output and/or elevated intracardiac pressures at rest or during stress.
Measured: at 12 months
All-cause mortality at 12 months
Death from any cause
Measured: at 12 months
Admission for heart failure at 12 months
Admission to hospital with clinical syndrome of heart failure, defined as per the ESC guidelines as typical symptoms (e.g. breathlessness, ankle swelling and fatigue) that may be accompanied by signs (e.g. elevated jugular venous pressure, pulmonary crackles and peripheral oedema) caused by a structural and/or functional cardiac abnormality, resulting in a reduced cardiac output and/or elevated intracardiac pressures at rest or during stress.
Measured: at 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jan 2019
- Study start11 Oct 2019
- Primary completion3 Mar 2023 (estimated)
- Study completion1 Feb 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiogenic ShockStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Prospective, open, multicentre, randomised strategy trial in Cardiogenic Shock (CGS)
- Masking
- None (open label)
- Enrolment
- 428 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Leicester
- Sponsor type
- University, hospital or other
- Collaborators
- European Commission, University of Glasgow, KU Leuven, University of East Anglia, Deutsches Herzzentrum Muenchen, A.O. Ospedale Papa Giovanni XXIII, Chalice Medical Ltd, Ludwig-Maximilians - University of Munich, University of Tromso, Institut d'Investigacions Biomèdiques August Pi i Sunyer, Paula Stradina Liniska Universitates, Accelopment AG, Universiteit Antwerpen, European Cardiovascular Research Center
- Responsible party
- Sponsor
- Investigators
- Anthony H Gershlick, Principal investigator, University of Leicester
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03813134
- Sponsor's protocol ID
- 0658
- Acronym
- EUROSHOCK
- Status last verified
- Apr 2021
- First submitted
- 19 Dec 2018
- Last updated
- 3 May 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- EURO SHOCK Testing the Value of Novel Strategy and Its Cost Efficacy in Order to Improve the Poor Outcomes in Cardiogenic Shock
- ClinicalTrials.gov ID
- NCT03813134
- Acronym / sponsor ID
- EUROSHOCK / 0658
- Conditions
- Cardiogenic Shock
- Keywords
- Cardiogenic Shock, Acute Myocardial Infarction, Acute Coronary Syndrome
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 428 participants (estimated)
- Lead sponsor
- University of LeicesterUniversity, hospital or other
- Collaborators
- European Commission, University of Glasgow, KU Leuven, University of East Anglia, Deutsches Herzzentrum Muenchen, A.O. Ospedale Papa Giovanni XXIII, Chalice Medical Ltd, Ludwig-Maximilians - University of Munich, University of Tromso, Institut d'Investigacions Biomèdiques August Pi i Sunyer, Paula Stradina Liniska Universitates, Accelopment AG, Universiteit Antwerpen, European Cardiovascular Research Center
- Study start
- 11 Oct 2019 (actual)
- Primary completion
- 3 Mar 2023 (estimated)
- Study completion
- 1 Feb 2024 (estimated)
- First posted
- 23 Jan 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
The EURO SHOCK trial tests the novel use of early deployment of mechanical support device in Cardiogenic Shock (CGS) in a randomised, strategy trial, with evidence of benefit or otherwise measured by recording hard clinical end-point outcomes.
Extra Corporeal Membrane Oxygenation (ECMO) is already used in CGS. This is therefore not a novel therapy. It is the use of ECMO early in the development of CGS that is the novel aspect of this project. The Investigators will test whether a strategy of very early ECMO can ameliorate the rapid decline that many CGS patients suffer. The value of deploying a clinically used and approved device prospectively and early in the natural history of CGS compared to standard practice has not been tested before and will be the basis of the EURO SHOCK project.
This trial itself will be a prospective randomized, open label, design study that will compare two groups of patients: Both will receive appropriate percutaneous coronary intervention (PCI) as is current practice as they arrive at the hospital.
- Group 1 will receive immediate PCI + standard care (pharmacological support).
- Group 2 will receive immediate PCI plus support with early peripheral veno-arterial ECMO + standard care (pharmacological support).
The Investigators will also compare the cost-effectiveness of early VA-ECMO, as compared to current standard of care. EURO SHOCK will also evaluate novel CMR protocols in these unwell patients, and also whether systems of urgent flagged transfer of the unwell patient is practical and beneficial. The Investigators will determine whether there are biological and ECG markers that predict worse patient outcomes, which could thus help select most appropriate patients for expedited treatments (the patient is only transferred if needed).
Although at the centre of the project there is a randomised trial, other important objectives will therefore be delivered.
The research study will additionally focus, through a-priori, post-hoc analyses, on higher risk and vulnerable sub groups such as the elderly (>75 years) and females, the importance of site of infarct and on those with multi-morbidities such as diabetes. These post-hoc data will be published separately.
The trial will include patients with out of hospital cardiac arrest (OHCA) who have documented return of spontaneous circulation (ROSC) but with certain caveats (see exclusion criteria).
The primary outcome is the all-cause mortality at 30 days following admission with acute coronary syndrome with cardiogenic shock. Key secondary outcomes will include all- cause mortality or admission with heart failure at 12 months, all-cause mortality at 12 months and admission to hospital with heart failure at 12 months.
A cornerstone of this research programme will be to determine the cost-efficacy of ECMO in this setting. Cost benefit will be measured both immediately and in the longer term testing for example any impact of need for heart failure therapies. This will be undertaken with evaluations of the cost-effectiveness of the device and evaluation of quality of life using the EuroQuol-5D-5L and the Minnesota Living with Heart Failure Questionnaire.
The EUROSHOCK trial will also include the following sub-studies:
- Cardiovascular MRI: Cardio-Renal Imaging Sub-study using novel shortened, non-breath-holding protocols.
- Platelet Function Sub-study designed to access the impact of novel ECMO coatings on platelet activation.
The programme will be developed and run through a carefully thought through management structure comprising 8 separate but interlinked work programmes (each targeted at one aspect of the project and headed by an experienced clinical trialist or trial manager) and involve the dissemination of results through a designated dissemination work package. Attention to translating the results to subsequent on-the-ground patient care will be an important aim for the management and dissemination team, and will involve patient support groups, professional societies and information delivered directly to the medical and non- medical staff caring for CGS patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Prospective, open, multicentre, randomised strategy trial in Cardiogenic Shock (CGS)
| Arm | Type | Receives |
|---|---|---|
| Immediate PCI with medical therapy | Active comparator | Procedure: Percutaneous coronary intervention (PCI), Other: Pharmacological SupportGroup 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 | Experimental | Procedure: Percutaneous coronary intervention (PCI), Other: Pharmacological Support, Device: VA-ECMOGroup 2 will receive immediate PCI plus standard pharmacological support with early peripheral veno-arterial ECMO. |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- 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.
Key exclusion criteria (15 listed)
- 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.).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Procedure or surgery | Immediate PCI with early VA-ECMO, Immediate PCI with medical therapy |
| Pharmacological SupportUse 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. | Other | Immediate PCI with early VA-ECMO, Immediate PCI with medical therapy |
| VA-ECMOAlso: Veno-Arterial Extra Corporeal Membrane Oxygenation.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. | Device | Immediate PCI with early VA-ECMO |
Primary outcome
All-cause mortality at 30 days
Time frame: at 30 days
Death from any cause
3 secondary outcomes
All-cause mortality or admission for heart failure at 12 months
Time frame: at 12 months
All-cause mortality at 12 months
Time frame: at 12 months
Admission for heart failure at 12 months
Time frame: at 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 May 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Anthony H Gershlick principal investigator
University of Leicester
47 sites in 8 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Percutaneous coronary intervention (PCI), Pharmacological Support and VA-ECMO in people with Cardiogenic Shock, run by University of Leicester at 47 sites in 8 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 13 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 3 May 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 47 sites in United Kingdom, Belgium, Germany, Italy, Spain and 3 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Anthony H Gershlick (0116 256 3887, ahg8@le.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
All-cause mortality at 30 days (time frame: at 30 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 May 2021.