Instantaneous wave-free ratio guided multivessel revascularisation during percutaneous coronary intervention for acute myocardial infarction: study protocol of the randomised controlled iMODERN trial

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  • Casper W H Beijnink, Institute of Cardiology, Emergency Cardiology Department, Kiev, Ukraine.
  • ,
  • Troels Thim
  • Dirk Jan van der Heijden, Institute of Cardiology, Emergency Cardiology Department, Kiev, Ukraine.
  • ,
  • Igor Klem, Duke University & Duke University Medical Center
  • ,
  • Rasha Al-Lamee, Faculty of Medicine, Imperial College London
  • ,
  • Jacqueline L Vos, Institute of Cardiology, Emergency Cardiology Department, Kiev, Ukraine.
  • ,
  • Yvonne Koop, Institute of Cardiology, Emergency Cardiology Department, Kiev, Ukraine.
  • ,
  • Marcel G W Dijkgraaf, Center for Clinical Epidemiology, Odense University Hospital, Odense, Denmark Research Unit of Clinical Epidemiology, Institute of Clinical Research, University of Southern Denmark, Odense, Denmark.
  • ,
  • Marcel A M Beijk, Institute of Cardiology, Emergency Cardiology Department, Kiev, Ukraine.
  • ,
  • Raymond J Kim, Duke University & Duke University Medical Center
  • ,
  • Justin Davies, Imperial Coll London, Imperial College London, Imperial Clin Trials Unit
  • ,
  • Luis Raposo, Centro Hospitalar Lisboa Ocidental, EPE/Hospital de Egas Moniz, Lisbon, Portugal.
  • ,
  • Sérgio B Baptista, Hospital Prof. Doutor Fernando Fonseca
  • ,
  • Javier Escaned, Hospital Clínico Universitario San Carlos
  • ,
  • Jan J Piek, Institute of Cardiology, Emergency Cardiology Department, Kiev, Ukraine.
  • ,
  • Michael Maeng
  • Niels van Royen, Institute of Cardiology, Emergency Cardiology Department, Kiev, Ukraine.
  • ,
  • Robin Nijveldt, Institute of Cardiology, Emergency Cardiology Department, Kiev, Ukraine.

INTRODUCTION: Recent randomised clinical trials showed benefit of non-culprit lesion revascularisation in ST-elevation myocardial infarction (STEMI) patients. However, it remains unclear whether revascularisation should be performed at the index procedure or at a later stage.

METHODS AND ANALYSIS: The instantaneous wave-free ratio (iFR) Guided Multivessel Revascularisation During Percutaneous Coronary Intervention for Acute Myocardial Infarction trial is a multicentre, randomised controlled prospective open-label trial with blinded evaluation of endpoints. After successful primary percutaneous coronary intervention (PCI), eligible STEMI patients with residual non-culprit lesions are randomised, to instantaneous wave-free ratio guided treatment of non-culprit lesions during the index procedure versus deferred cardiac MR-guided management within 4 days to 6 weeks. The primary endpoint of the study is the combined occurrence of all-cause death, recurrent myocardial infarction and hospitalisation for heart failure at 12 months follow-up. Clinical follow-up includes questionnaires at 3 months and outpatient visits at 6 months and 12 months after primary PCI. Furthermore, a cost-effectiveness analysis will be performed.

ETHICS AND DISSEMINATION: Permission to conduct this trial has been granted by the Medical Ethical Committee of the Amsterdam University Medical Centres (loc. VUmc, ID NL60107.029.16). The primary results of this trial will be shared in a main article and subgroup analyses or spin-off studies will be shared in secondary papers.

TRIAL REGISTRATION NUMBER: NCT03298659.

OriginalsprogEngelsk
Artikelnummere044035
TidsskriftBMJ Open
Vol/bind11
Nummer1
Antal sider9
ISSN2044-6055
DOI
StatusUdgivet - jan. 2021

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