Instantaneous wave-free ratio guided multivessel revascularisation during percutaneous coronary intervention for acute myocardial infarction: study protocol of the randomised controlled iMODERN trial.
coronary heart disease
coronary intervention
ischaemic heart disease
magnetic resonance imaging
myocardial infarction
Journal
BMJ open
ISSN: 2044-6055
Titre abrégé: BMJ Open
Pays: England
ID NLM: 101552874
Informations de publication
Date de publication:
15 01 2021
15 01 2021
Historique:
entrez:
16
1
2021
pubmed:
17
1
2021
medline:
10
4
2021
Statut:
epublish
Résumé
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. 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. 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. NCT03298659.
Identifiants
pubmed: 33452200
pii: bmjopen-2020-044035
doi: 10.1136/bmjopen-2020-044035
pmc: PMC7813313
doi:
Banques de données
ClinicalTrials.gov
['NCT03298659']
Types de publication
Clinical Trial Protocol
Journal Article
Research Support, Non-U.S. Gov't
Langues
eng
Sous-ensembles de citation
IM
Pagination
e044035Informations de copyright
© 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.
Déclaration de conflit d'intérêts
Competing interests: None declared.
Références
JAMA Cardiol. 2019 Aug 1;4(8):736-744
pubmed: 31268466
Lancet. 2003 Feb 1;361(9355):374-9
pubmed: 12573373
JAMA. 2007 May 9;297(18):1985-91
pubmed: 17488963
Lancet. 2012 Feb 4;379(9814):453-60
pubmed: 22196944
J Am Coll Cardiol. 2015 Mar 17;65(10):963-72
pubmed: 25766941
JACC Cardiovasc Imaging. 2020 Jul;13(7):1505-1517
pubmed: 32417337
Eur Heart J. 2008 Feb;29(4):480-9
pubmed: 18208849
JACC Cardiovasc Interv. 2018 Aug 13;11(15):1437-1449
pubmed: 30093050
N Engl J Med. 2013 Sep 19;369(12):1115-23
pubmed: 23991625
Circulation. 2018 Jun 12;137(24):2635-2650
pubmed: 29891620
N Engl J Med. 2012 Sep 13;367(11):991-1001
pubmed: 22924638
Lancet. 2015 Aug 15;386(9994):665-71
pubmed: 26347918
Eur Heart J. 2018 Jan 7;39(2):119-177
pubmed: 28886621
Am J Cardiol. 2020 May 15;125(10):1486-1491
pubmed: 32200948
JAMA. 2014 Nov 19;312(19):2019-27
pubmed: 25399277
N Engl J Med. 2020 Apr 9;382(15):1395-1407
pubmed: 32227755
N Engl J Med. 2019 Jun 20;380(25):2418-2428
pubmed: 31216398
J Am Heart Assoc. 2015 Aug 27;4(9):e001956
pubmed: 26316523
Eur Heart J. 2007 Jul;28(14):1709-16
pubmed: 17556348
Am J Cardiol. 2010 Feb 1;105(3):318-22
pubmed: 20102942
N Engl J Med. 2009 Jan 15;360(3):213-24
pubmed: 19144937
N Engl J Med. 2019 Oct 10;381(15):1411-1421
pubmed: 31475795
N Engl J Med. 2017 Mar 30;376(13):1234-1244
pubmed: 28317428
Nature. 2012 Jul 19;487(7407):325-9
pubmed: 22763456
Int J Cardiovasc Imaging. 2014 Feb;30(2):253-61
pubmed: 24420418
N Engl J Med. 2017 May 11;376(19):1824-1834
pubmed: 28317458
Ann Intern Med. 2013 Feb 5;158(3):200-7
pubmed: 23295957
J Am Coll Cardiol. 2012 Apr 10;59(15):1392-402
pubmed: 22154731
N Engl J Med. 2017 May 11;376(19):1813-1823
pubmed: 28317438
JACC Cardiovasc Interv. 2017 Dec 26;10(24):2528-2535
pubmed: 29198461