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

Casper W.H. Beijnink, Troels Thim, DIrk Jan Van Der Heijden, Igor Klem, Rasha Al-Lamee, Jacqueline L. Vos, Yvonne Koop, Marcel G.W. DIjkgraaf, Marcel A.M. Beijk, Raymond J. Kim, Justin Davies, Luis Raposo, Sérgio B. Baptista, Javier Escaned, Jan J. Piek, Michael Maeng, Niels Van Royen, Robin Nijveldt*

*Corresponding author for this work

Research output: Contribution to journalArticleAcademicpeer-review

2 Citations (Scopus)

Abstract

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.

Original languageEnglish
Article numbere044035
Pages (from-to)e044035
JournalBMJ Open
Volume11
Issue number1
DOIs
Publication statusPublished - 15 Jan 2021
Externally publishedYes

Keywords

  • coronary heart disease
  • coronary intervention
  • ischaemic heart disease
  • magnetic resonance imaging
  • myocardial infarction

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