428
Participants
Start Date
October 11, 2019
Primary Completion Date
March 3, 2023
Study Completion Date
February 1, 2024
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."
RECRUITING
Paula Stradina Liniska Universitates Slimnica AS, Riga
NOT_YET_RECRUITING
Medical University of Vienna, Vienna
NOT_YET_RECRUITING
AZ Monica, Deurne
NOT_YET_RECRUITING
AZ Turnhout, Turnhout
NOT_YET_RECRUITING
University Hospital Antwerpen, Antwerp
NOT_YET_RECRUITING
ZNA Middelheim, Antwerp
NOT_YET_RECRUITING
Imelda Hospital Bonheiden, Bonheiden
RECRUITING
Katholieke Universiteit Leuven, Leuven
NOT_YET_RECRUITING
Jessa Ziekenhuis Hasselt, Hasselt
NOT_YET_RECRUITING
The Nordland Hospital, Bodø
NOT_YET_RECRUITING
The Helgeland Hospital, Mo i Rana
NOT_YET_RECRUITING
AZ Gent, Ghent
RECRUITING
Universitetet i Tromsoe, Tromsø
NOT_YET_RECRUITING
Algemeen Stedelijk Ziekenhuis Aalst, Aalst
NOT_YET_RECRUITING
Onze Lieve Vrouw Hospital Aalst, Aalst
NOT_YET_RECRUITING
The Finnmark Hospital, Hammerfest
NOT_YET_RECRUITING
Ospedale San Giovanni Bosco di Torino, Torino
NOT_YET_RECRUITING
Segeberger Kliniken GmbH, Bad Segeberg
NOT_YET_RECRUITING
Azienda Ospedalierea Papa Giovanni XXIII, Bergamo
NOT_YET_RECRUITING
Università degli Studi di Padova, Padua
NOT_YET_RECRUITING
University Hospital of Bologna Policlinico S. Orsola - Malpighi, Bologna
NOT_YET_RECRUITING
Azienda Universitaria Ospedaliera Careggi, Firenze, Florence
NOT_YET_RECRUITING
Uniklinikum Tübingen, Tübingen
NOT_YET_RECRUITING
Herz-Zentrum Bodensee, Konstanz
NOT_YET_RECRUITING
Universitäts-Herzzentrum Freiburg-Bad Krozingen, Bad Krozingen
RECRUITING
Klinikum Campus Innenstadt, München
RECRUITING
Deutsches Herzzentrum München, München
NOT_YET_RECRUITING
Barmherzige Brüder gemeinnützige Krankenhaus GmbH, München
NOT_YET_RECRUITING
Klinik Augustinum, München
NOT_YET_RECRUITING
Klinikum Rechts Der Isar, Munich
RECRUITING
Ludwig-Maximilians-Universität München, München
RECRUITING
Hospital Germans Trias I Pujol, Badalona
RECRUITING
Hospital Vall d'Hebron, Barcelona
RECRUITING
Consorci Institut D'Investicacions Biomediques August Pi i Sunyer / Hospital Clinic de Barcelona, Barcelona
NOT_YET_RECRUITING
Hospital de Sant Pau, Barcelona
RECRUITING
Hospital de Bellvitge, Barcelona
NOT_YET_RECRUITING
University Hospital Leicester, Leicester
NOT_YET_RECRUITING
Hairmyres Hospital, Airdrie
RECRUITING
University of Leicester, Leicester
NOT_YET_RECRUITING
Newcastle Freeman Hospital, Newcastle
NOT_YET_RECRUITING
University of Glasgow, Glasgow
NOT_YET_RECRUITING
Papworth Hospital, Cambridge
NOT_YET_RECRUITING
Golden Jubilee National Hospital, Glasgow
NOT_YET_RECRUITING
St Barts and the London Hospital, London
RECRUITING
Kings College Hospital, London
RECRUITING
Harefield and Brompton London, London
NOT_YET_RECRUITING
Guys and St Thomas NHS Foundation Trust, London
Collaborators (1)
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