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

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.

journal_name

BMJ Open

journal_title

BMJ open

authors

Beijnink CWH,Thim T,van der Heijden DJ,Klem I,Al-Lamee R,Vos JL,Koop Y,Dijkgraaf MGW,Beijk MAM,Kim RJ,Davies J,Raposo L,Baptista SB,Escaned J,Piek JJ,Maeng M,van Royen N,Nijveldt R

doi

10.1136/bmjopen-2020-044035

subject

Has Abstract

pub_date

2021-01-15 00:00:00

pages

e044035

issue

1

issn

2044-6055

pii

bmjopen-2020-044035

journal_volume

11

pub_type

杂志文章

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