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 The...
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BMJ Publishing Group
2021-01-01
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| author | Jan J Piek Javier Escaned Niels van Royen Rasha Al-Lamee Justin Davies Michael Maeng Marcel G W Dijkgraaf Robin Nijveldt Troels Thim Casper W H Beijnink Dirk Jan van der Heijden Igor Klem Jacqueline L Vos Yvonne Koop Marcel A M Beijk Raymond J Kim Luis Raposo Sérgio B Baptista |
| author_facet | Jan J Piek Javier Escaned Niels van Royen Rasha Al-Lamee Justin Davies Michael Maeng Marcel G W Dijkgraaf Robin Nijveldt Troels Thim Casper W H Beijnink Dirk Jan van der Heijden Igor Klem Jacqueline L Vos Yvonne Koop Marcel A M Beijk Raymond J Kim Luis Raposo Sérgio B Baptista |
| author_sort | Jan J Piek |
| collection | DOAJ |
| 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 | Article |
| id | doaj-art-e29d7dae6f9148da862f2e895c13dfa8 |
| institution | Kabale University |
| issn | 2044-6055 |
| language | English |
| publishDate | 2021-01-01 |
| publisher | BMJ Publishing Group |
| record_format | Article |
| series | BMJ Open |
| spelling | doaj-art-e29d7dae6f9148da862f2e895c13dfa82024-11-18T17:30:09ZengBMJ Publishing GroupBMJ Open2044-60552021-01-0111110.1136/bmjopen-2020-044035Instantaneous wave-free ratio guided multivessel revascularisation during percutaneous coronary intervention for acute myocardial infarction: study protocol of the randomised controlled iMODERN trialJan J Piek0Javier Escaned1Niels van Royen2Rasha Al-Lamee3Justin Davies4Michael Maeng5Marcel G W Dijkgraaf6Robin Nijveldt7Troels Thim8Casper W H Beijnink9Dirk Jan van der Heijden10Igor Klem11Jacqueline L Vos12Yvonne Koop13Marcel A M Beijk14Raymond J Kim15Luis Raposo16Sérgio B Baptista17Cardiology, Amsterdam UMC Locatie AMC, Amsterdam, The NetherlandsInterventional Cardiology, Hospital Clínico Universitario San Carlos, Madrid, SpainCardiology, Radboudumc, Nijmegen, The Netherlands2National Heart and Lung Institute Imperial College, London, UKFaculty of Medicine, Imperial College London, London, UKDepartment of Cardiology, Aarhus University Hospital, Aarhus N, DenmarkClinical Epidemiology, Biostatistics and Bioinformatics, Amsterdam UMC - Locatie AMC, Amsterdam, The NetherlandsCardiology, Radboudumc, Nijmegen, The NetherlandsDepartment of Cardiology, Aarhus University Hospital, Aarhus N, DenmarkCardiology, Radboudumc, Nijmegen, The NetherlandsCardiology, Medisch Centrum Haaglanden, Den Haag, The NetherlandsCardiology, Duke University Medical Center, Durham, North Carolina, USACardiology, Radboudumc, Nijmegen, The NetherlandsCardiology, Radboudumc, Nijmegen, The NetherlandsDepartment of Cardiology, Amsterdam University Medical Centers, University of Amsterdam, Amsterdam Cardiovascular Sciences, Amsterdam, The NetherlandsCardiology, Duke University Medical Center, Durham, North Carolina, USACardiology, Centro Hospitalar de Lisboa Ocidental EPE, Lisboa, PortugalCardiology Department, Hospital Fernando Fonseca, Amadora, PortugalIntroduction 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.https://bmjopen.bmj.com/content/11/1/e044035.full |
| spellingShingle | Jan J Piek Javier Escaned Niels van Royen Rasha Al-Lamee Justin Davies Michael Maeng Marcel G W Dijkgraaf Robin Nijveldt Troels Thim Casper W H Beijnink Dirk Jan van der Heijden Igor Klem Jacqueline L Vos Yvonne Koop Marcel A M Beijk Raymond J Kim Luis Raposo Sérgio B Baptista Instantaneous wave-free ratio guided multivessel revascularisation during percutaneous coronary intervention for acute myocardial infarction: study protocol of the randomised controlled iMODERN trial BMJ Open |
| 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 |
| url | https://bmjopen.bmj.com/content/11/1/e044035.full |
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