TY - JOUR
T1 - Instantaneous wave-free ratio guided multivessel revascularisation during percutaneous coronary intervention for acute myocardial infarction
T2 - Study protocol of the randomised controlled iMODERN trial
AU - Beijnink, Casper W.H.
AU - Thim, Troels
AU - Van Der Heijden, DIrk Jan
AU - Klem, Igor
AU - Al-Lamee, Rasha
AU - Vos, Jacqueline L.
AU - Koop, Yvonne
AU - DIjkgraaf, Marcel G.W.
AU - Beijk, Marcel A.M.
AU - Kim, Raymond J.
AU - Davies, Justin
AU - Raposo, Luis
AU - Baptista, Sérgio B.
AU - Escaned, Javier
AU - Piek, Jan J.
AU - Maeng, Michael
AU - Van Royen, Niels
AU - Nijveldt, Robin
N1 - Funding Information:
Funding Philips and Biotronik supported this investigator-initiated study by an unrestricted grant to the Radboudumc (no grant number). In addition, the study is financed by the Ministry of Economic Affairs of the Netherlands by a PPP allowance (grant number LSHM 16036).
Publisher Copyright:
© 2021 BMJ Publishing Group. All rights reserved.
PY - 2021/1/15
Y1 - 2021/1/15
N2 - 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.
AB - 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.
KW - coronary heart disease
KW - coronary intervention
KW - ischaemic heart disease
KW - magnetic resonance imaging
KW - myocardial infarction
UR - http://www.scopus.com/inward/record.url?scp=85099559358&partnerID=8YFLogxK
U2 - 10.1136/bmjopen-2020-044035
DO - 10.1136/bmjopen-2020-044035
M3 - Article
C2 - 33452200
AN - SCOPUS:85099559358
SN - 2044-6055
VL - 11
SP - e044035
JO - BMJ Open
JF - BMJ Open
IS - 1
M1 - e044035
ER -