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Instantaneous wave-free ratio guided multivessel revascularisation during percutaneous coronary intervention for acute myocardial infarction: study protocol of the randomised controlled iMODERN trial
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: T...
Autores principales: | , , , , , , , , , , , , , , , , , |
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Formato: | Online Artículo Texto |
Lenguaje: | English |
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BMJ Publishing Group
2021
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Materias: | |
Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7813313/ https://www.ncbi.nlm.nih.gov/pubmed/33452200 http://dx.doi.org/10.1136/bmjopen-2020-044035 |
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author | Beijnink, Casper W H Thim, Troels van der Heijden, Dirk Jan Klem, Igor Al-Lamee, Rasha Vos, Jacqueline L Koop, Yvonne Dijkgraaf, Marcel G W Beijk, Marcel A M Kim, Raymond J Davies, Justin Raposo, Luis Baptista, Sérgio B Escaned, Javier Piek, Jan J Maeng, Michael van Royen, Niels Nijveldt, Robin |
author_facet | Beijnink, Casper W H Thim, Troels van der Heijden, Dirk Jan Klem, Igor Al-Lamee, Rasha Vos, Jacqueline L Koop, Yvonne Dijkgraaf, Marcel G W Beijk, Marcel A M Kim, Raymond J Davies, Justin Raposo, Luis Baptista, Sérgio B Escaned, Javier Piek, Jan J Maeng, Michael van Royen, Niels Nijveldt, Robin |
author_sort | Beijnink, Casper W H |
collection | PubMed |
description | 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. |
format | Online Article Text |
id | pubmed-7813313 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2021 |
publisher | BMJ Publishing Group |
record_format | MEDLINE/PubMed |
spelling | pubmed-78133132021-01-25 Instantaneous wave-free ratio guided multivessel revascularisation during percutaneous coronary intervention for acute myocardial infarction: study protocol of the randomised controlled iMODERN trial Beijnink, Casper W H Thim, Troels van der Heijden, Dirk Jan Klem, Igor Al-Lamee, Rasha Vos, Jacqueline L Koop, Yvonne Dijkgraaf, Marcel G W Beijk, Marcel A M Kim, Raymond J Davies, Justin Raposo, Luis Baptista, Sérgio B Escaned, Javier Piek, Jan J Maeng, Michael van Royen, Niels Nijveldt, Robin BMJ Open Cardiovascular Medicine 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. BMJ Publishing Group 2021-01-15 /pmc/articles/PMC7813313/ /pubmed/33452200 http://dx.doi.org/10.1136/bmjopen-2020-044035 Text en © Author(s) (or their employer(s)) 2021. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ. http://creativecommons.org/licenses/by-nc/4.0/ http://creativecommons.org/licenses/by-nc/4.0/This is an open access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited, appropriate credit is given, any changes made indicated, and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/4.0/. |
spellingShingle | Cardiovascular Medicine Beijnink, Casper W H Thim, Troels van der Heijden, Dirk Jan Klem, Igor Al-Lamee, Rasha Vos, Jacqueline L Koop, Yvonne Dijkgraaf, Marcel G W Beijk, Marcel A M Kim, Raymond J Davies, Justin Raposo, Luis Baptista, Sérgio B Escaned, Javier Piek, Jan J Maeng, Michael van Royen, Niels Nijveldt, Robin Instantaneous wave-free ratio guided multivessel revascularisation during percutaneous coronary intervention for acute myocardial infarction: study protocol of the randomised controlled iMODERN trial |
title | Instantaneous wave-free ratio guided multivessel revascularisation during percutaneous coronary intervention for acute myocardial infarction: study protocol of the randomised controlled iMODERN trial |
title_full | Instantaneous wave-free ratio guided multivessel revascularisation during percutaneous coronary intervention for acute myocardial infarction: study protocol of the randomised controlled iMODERN trial |
title_fullStr | Instantaneous wave-free ratio guided multivessel revascularisation during percutaneous coronary intervention for acute myocardial infarction: study protocol of the randomised controlled iMODERN trial |
title_full_unstemmed | Instantaneous wave-free ratio guided multivessel revascularisation during percutaneous coronary intervention for acute myocardial infarction: study protocol of the randomised controlled iMODERN trial |
title_short | Instantaneous wave-free ratio guided multivessel revascularisation during percutaneous coronary intervention for acute myocardial infarction: study protocol of the randomised controlled iMODERN trial |
title_sort | instantaneous wave-free ratio guided multivessel revascularisation during percutaneous coronary intervention for acute myocardial infarction: study protocol of the randomised controlled imodern trial |
topic | Cardiovascular Medicine |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7813313/ https://www.ncbi.nlm.nih.gov/pubmed/33452200 http://dx.doi.org/10.1136/bmjopen-2020-044035 |
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