Testing the Value of Novel Strategy and Its Cost Efficacy in Order to Improve the Poor Outcomes in Cardiogenic Shock
NCT ID: NCT03813134
Last Updated: 2021-05-03
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
UNKNOWN
NA
428 participants
INTERVENTIONAL
2019-10-11
2024-02-01
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
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.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Intraaortic Balloon Pump in Cardiogenic Shock II
NCT00491036
Shock Trial: Should We Emergently Revascularize Occluded Coronaries for Cardiogenic Shock.
NCT00000552
Low-Dose Dobutamine and Single-Dose Tocilizumab in Acute Myocardial Infarction With High Risk of Cardiogenic Shock
NCT05350592
Efficacy Study of LV Assist Device to Treat Patients With Cardiogenic Shock (ISAR-SHOCK)
NCT00417378
Clinical Effects of Intra-aortic Balloon Support in Early Acute Coronary Syndrome and Non-Acute Coronary Syndrome Related Cardiogenic Shock
NCT06414187
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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.
1. Group 1 will receive immediate PCI + standard care (pharmacological support).
2. 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:
1. Cardiovascular MRI: Cardio-Renal Imaging Sub-study using novel shortened, non-breath-holding protocols.
2. 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
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Immediate PCI with medical therapy
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.
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.
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.
Immediate PCI with early VA-ECMO
Group 2 will receive immediate PCI plus standard pharmacological support with early peripheral veno-arterial ECMO.
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.
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.
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.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
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.
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.
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.
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
2. Presentation CGS within 24 hours of onset of Acute Coronary Syndrome (ACS) symptoms.
3. 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)
4. PCI has been attempted.
5. 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.
6. Provision of informed assent followed by patient consent; \[or relative or physician consent if the patient is unable to consent\].
Exclusion Criteria
2. 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).
3. Age \<18 and\>90 years.
4. Deemed appropriately frail (≥ 5 Canadian frailty score)
5. Shock from another cause (sepsis, haemorrhagic/hypovolaemic shock, anaphylaxis, myocarditis etc.).
6. Significant systemic illness
7. Known dementia of any severity.
8. Comorbidity with life expectancy \<12 months.
9. Severe peripheral vascular disease (precluding access making ECMO contra- indicated).
10. Severe allergy or intolerance to pharmacological or antithrombotic anti-platelet agents.
11. 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.
12. Involved in another randomised research trial within the last 12 months.
13. Arterial lactate level of \<2.0 mmol per litre.
18 Years
90 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
European Commission
OTHER
University of Glasgow
OTHER
KU Leuven
OTHER
University of East Anglia
OTHER
Deutsches Herzzentrum Muenchen
OTHER
A.O. Ospedale Papa Giovanni XXIII
OTHER
Chalice Medical Ltd
UNKNOWN
Ludwig-Maximilians - University of Munich
OTHER
University of Tromso
OTHER
Institut d'Investigacions Biomèdiques August Pi i Sunyer
OTHER
Paula Stradina Liniska Universitates
UNKNOWN
Accelopment AG
OTHER
Universiteit Antwerpen
OTHER
European Cardiovascular Research Center
NETWORK
University of Leicester
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Anthony H Gershlick
Role: PRINCIPAL_INVESTIGATOR
University of Leicester
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Medical University of Vienna
Vienna, Vienna, Austria
Algemeen Stedelijk Ziekenhuis Aalst
Aalst, , Belgium
Onze Lieve Vrouw Hospital Aalst
Aalst, , Belgium
University Hospital Antwerpen
Antwerp, , Belgium
ZNA Middelheim
Antwerp, , Belgium
Imelda Hospital Bonheiden
Bonheiden, , Belgium
AZ Monica
Deurne, , Belgium
AZ Gent
Ghent, , Belgium
Jessa Ziekenhuis Hasselt
Hasselt, , Belgium
Katholieke Universiteit Leuven
Leuven, , Belgium
AZ Turnhout
Turnhout, , Belgium
Universitäts-Herzzentrum Freiburg-Bad Krozingen
Bad Krozingen, , Germany
Segeberger Kliniken GmbH
Bad Segeberg, , Germany
Herz-Zentrum Bodensee
Konstanz, , Germany
Klinikum Rechts Der Isar
Munich, , Germany
Klinikum Campus Innenstadt
München, , Germany
Deutsches Herzzentrum München
München, , Germany
Barmherzige Brüder gemeinnützige Krankenhaus GmbH
München, , Germany
Klinik Augustinum
München, , Germany
Ludwig-Maximilians-Universität München
München, , Germany
Uniklinikum Tübingen
Tübingen, , Germany
Azienda Ospedalierea Papa Giovanni XXIII
Bergamo, , Italy
University Hospital of Bologna Policlinico S. Orsola - Malpighi
Bologna, , Italy
Azienda Universitaria Ospedaliera Careggi, Firenze
Florence, , Italy
Università degli Studi di Padova
Padua, , Italy
Ospedale San Giovanni Bosco di Torino
Torino, , Italy
Paula Stradina Liniska Universitates Slimnica AS
Riga, , Latvia
The Nordland Hospital
Bodø, , Norway
The Finnmark Hospital
Hammerfest, , Norway
The Helgeland Hospital
Mo i Rana, , Norway
Universitetet i Tromsoe
Tromsø, , Norway
Hospital Germans Trias I Pujol
Badalona, , Spain
Hospital Vall d'Hebron
Barcelona, , Spain
Consorci Institut D'Investicacions Biomediques August Pi i Sunyer / Hospital Clinic de Barcelona
Barcelona, , Spain
Hospital de Sant Pau
Barcelona, , Spain
Hospital de Bellvitge
Barcelona, , Spain
University Hospital Leicester
Leicester, East Midlands, United Kingdom
Hairmyres Hospital
Airdrie, Lanarkshire, United Kingdom
University of Leicester
Leicester, Leicestershire, United Kingdom
Newcastle Freeman Hospital
Newcastle, Newcastle Upon Tyne, United Kingdom
University of Glasgow
Glasgow, Scotland, United Kingdom
Papworth Hospital
Cambridge, , United Kingdom
Golden Jubilee National Hospital
Glasgow, , United Kingdom
St Barts and the London Hospital
London, , United Kingdom
Kings College Hospital
London, , United Kingdom
Harefield and Brompton London
London, , United Kingdom
Guys and St Thomas NHS Foundation Trust
London, , United Kingdom
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
Related Links
Access external resources that provide additional context or updates about the study.
Study website
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
0658
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.