In the Management of Coronary Artery Disease, Does Routine Pressure Wire Assessment at the Time of Coronary Angiography Affect Management Strategy, Hospital Costs and Outcomes? (RIPCORD 2)
8 agosto 2019 aggiornato da: University Hospital Southampton NHS Foundation Trust
A Randomised Controlled Trial to Compare Routine Pressure Wire Assessment With Conventional Angiography in the Management of Patients With Coronary Artery Disease.
A randomised controlled trial to compare two strategies for the investigation of coronary artery disease at the time of angiography.
Patients will be randomised to conventional angiography or additional, routine pressure wire assessment - measuring fractional flow reserve (FFR) - in all main vessels judged as being of sufficient vessel calibre to allow percutaneous coronary intervention (PCI) (experimental arm).
Panoramica dello studio
Stato
Sconosciuto
Condizioni
Intervento / Trattamento
Descrizione dettagliata
The study will recruit patients undergoing angiography for the investigation of stable angina or for the assessment of a recent, but stabilised, non-ST elevation acute coronary syndrome event.
Eligible patients who provide written informed consent will be randomised to conventional angiography or additional, routine pressure wire assessment - measuring fractional flow reserve (FFR) - in all main vessels judged as being of sufficient vessel calibre to allow percutaneous coronary intervention (PCI) (experimental arm).
The study pragmatic design allows investigators to conduct all diagnostic and therapeutic management in accordance with prevailing best practice patterns.
Study outcome measures will examine resource utilisation, patient reported quality of life and clinical events at 1 year.
Tipo di studio
Interventistico
Iscrizione (Effettivo)
1100
Fase
- Non applicabile
Contatti e Sedi
Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.
Luoghi di studio
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Bristol, Regno Unito, BS2 8HW
- Bristol Heart Institute - University Hospitals Bristol NHS Foundation Trust
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Dorset
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Bournemouth, Dorset, Regno Unito, BH7 7DW
- Royal Bournemouth Hospital - The Royal Bournemouth and Christchurch Hospitals NHS Foundation Trust
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East Sussex
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Brighton, East Sussex, Regno Unito, BN2 5BE
- Brighton and Sussex University Hospitals NHS Trust
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Hampshire
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Portsmouth, Hampshire, Regno Unito, PO6 3LY
- Queen Alexandra Hospital - Portsmouth Hospitals NHS Trust
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Southampton, Hampshire, Regno Unito, SO16 6YD
- Southampton General Hospital - University Hospitals Southampton NHS Foundation Trust
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Lancashire
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Blackburn, Lancashire, Regno Unito, BB2 3HH
- Royal Blackburn Teaching Hospital - East Lancashire Hospitals NHS Trust
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Merseyside
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Liverpool, Merseyside, Regno Unito, L14 3PE
- Liverpool Heart and Chest Hospital NHS Foundation Trust
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Northumberland
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Newcastle upon Tyne, Northumberland, Regno Unito, NE7 7DN
- Freeman Hospital - Newcastle Hospitals
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Nottinghamshire
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Mansfield, Nottinghamshire, Regno Unito, NG17 4JL
- King's Mill Hospital - Sherwood Forest Hospitals NHS Foundation Trust
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Nottingham, Nottinghamshire, Regno Unito, NG5 1PB
- City Hospital - Nottingham University Hospitals NHS Trust
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Scotland
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Glasgow, Scotland, Regno Unito, G81 4DY
- Golden Jubilee National Hospital
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South Yorkshire
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Sheffield, South Yorkshire, Regno Unito, S5 7AU
- Northern General Hospital - Sheffield Teaching Hospitals
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Staffordshire
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Stoke-on-Trent, Staffordshire, Regno Unito, ST4 6QG
- Royal Stoke University Hospital - University Hospitals of North Midlands
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West Midlands
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Birmingham, West Midlands, Regno Unito, B15 2TH
- Queen Elizabeth Hospital - University Hospitals Birmingham NHS Foundation Trust
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West Yorkshire
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Wakefield, West Yorkshire, Regno Unito, WF1 4DG
- Pinderfields Hospital - The Mid Yorkshire Hospitals NHS Trust
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Yorkshire
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Hull, Yorkshire, Regno Unito, HU16 5JQ
- Castle Hill Hospital - Hull and East Yorkshire Hospitals NHS Trust
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Leeds, Yorkshire, Regno Unito, LS1 3EX
- Leeds General Infirmary - Leeds Teaching Hospitals NHS Trust
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Criteri di partecipazione
I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.
Criteri di ammissibilità
Età idonea allo studio
18 anni e precedenti (Adulto, Adulto più anziano)
Accetta volontari sani
No
Sessi ammissibili allo studio
Tutto
Descrizione
· Inclusion criteria
o Outline Initial Inclusion Criteria (before entry to cath lab):
Patient scheduled for coronary angiography for the:
- Elective investigation of known or suspected coronary artery disease OR
Urgent investigation of a recent but stabilised, non-ST elevation acute coronary syndrome event
o Outline Angiographic Inclusion Criterion (after angiography):
- Presence of significant coronary disease defined as:
Any stenosis >30% reduction in luminal diameter, by visual estimate, in at least one vessel (main or branch) of sufficient calibre to permit the potential performance of PCI - approximately 2.25 mm diameter.
Key Exclusion Criteria
Screening phase exclusion criteria:
- ≤ 18 years of age
- Previous enrolment in this trial
- Currently enrolled into another study unless co-enrolment approved by Chief Investigator (CI) and the clinical trials unit (CTU)
- Inability to provide informed consent
- Residence outside the United Kingdom (UK) or other issues limiting the ability to secure clinical follow-up data to one year
- Non-cardiac pathology that may limit survival in the next year
- Clear contraindication to potential future management with CABG or PCI (patients should be a potential candidate for medical therapy or revascularisation with either PCI or surgery)
- Heart valve disease of sufficient import to consider valve replacement or other intervention as part of an index management strategy
- Hypertrophic cardiomyopathy
- Previous coronary artery surgery of any type
- Known chronic renal impairment with a current estimated glomerular filtration rate (eGFR) of < 45
- Anaemia with a current measured haemoglobin of < 100
- Angiography performed in the context of an ST elevation myocardial infarction event
- Any patient who at the time of planned angiography manifests haemodynamic instability, or recurrent sustained ventricular arrhythmia, or Mobitz type II or complete heart block
- Any patient who at the time of planned angiography manifests unstable chest pain symptoms at rest or has required the continuing use of intravenous nitrates or regular opioid analgesia to control symptoms
- Continuing use of intravenous glycoprotein 2b/3a (GP2b3a) agents before entry to the catheterisation laboratory
- Known intolerance, hypersensitivity or contraindication to adenosine - including significant reversible airways disease
- Additional investigations planned (or deemed likely to be required) for the assessment of myocardial ischaemia or viability. Examples of proposed tests that would constitute an exclusion criterion would include, but are not limited to, exercise tolerance testing, stress echocardiography, cardiac MRI viability or perfusion scanning or nuclear myocardial perfusion scanning.
- Active bleeding at the time of planned index angiography
- Pregnant women
Angiographic phase exclusion criteria:
- Single vessel occlusive coronary disease (TIMI flow <3) as sole disease
Patient not suitable for the immediate performance of a pressure wire assessment of all major vessels for any reason, for example:
- Patient discomfort
- Change in the clinical condition or complication of angiography requiring termination of the procedure or immediate intervention
- Significant use of radiographic contrast or X-Ray exposure during the initial angiography
- Inadequate angiographic images or failure to intubate any of the coronary vessels
- Aorto-ostial disease that would preclude accurate assessment of FFR
- Insufficient laboratory time
- Uncertain availability of key clinical and trial staff
- PW use in coronaries declared unsafe (e.g. tight or long disease)
- PW use in coronaries declared unsuitable (e.g. distal disease or complete cross-filling)
Piano di studio
Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Diagnostico
- Assegnazione: Randomizzato
- Modello interventistico: Assegnazione parallela
- Mascheramento: Nessuno (etichetta aperta)
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
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Nessun intervento: Conventional angiography
Routine angiography will be performed according to local best practice
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Sperimentale: Routine Measurement of FFR
Additional investigation with the measurement of FFR in all major vessels
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FFR measurement will be performed in all major vessels with normal (TIMI 3) flow.
Occluded vessels and vessels with TIMI flow <3 will not be examined but will be 'awarded' an FFR value of 0.5
Altri nomi:
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Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
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Primary Economic Outcome Measure
Lasso di tempo: One year
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Resource utilisation as determined by hospital care costs at one year; All hospital admissions will be tracked using national hospital episode statistics; the cost of each episode will be derived from a cost model using standard UK tariffs.
This analysis will compare the mean (or median) of the total hospital costs recorded for each patient over the 12 month follow-up period.
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One year
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Primary Quality of Life Outcome Measure
Lasso di tempo: One year
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Patient reported quality of life at one year using the EQ-5D health questionnaire.
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One year
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Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
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Mortalità per tutte le cause
Lasso di tempo: Un anno
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Un anno
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Management strategy information
Lasso di tempo: Reported once: Single declaration at index procedure after randomisation
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· Proportion of vessels deemed to demonstrate flow-limiting disease and targeted for revascularisation in the declared initial management strategy.
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Reported once: Single declaration at index procedure after randomisation
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Management strategy information
Lasso di tempo: Reported once: Single declaration at index procedure after randomisation
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· Proportion of patients scheduled for management with medical therapy, percutaneous coronary intervention (PCI) or coronary artery bypass graft (CABG) in the declared initial management strategy.
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Reported once: Single declaration at index procedure after randomisation
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Angina symptoms
Lasso di tempo: One year
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• Angina symptoms as reported by the research team after the 12 month contact, described by Canadian Cardiovascular Society Grade.
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One year
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Angina symptoms
Lasso di tempo: One year
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• Angina symptoms as reported by the patient with private completion of a screening form at 12 months, described by Canadian Cardiovascular Society Grade.
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One year
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Number of hospitalisation events
Lasso di tempo: One year
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One year
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Total hospital days
Lasso di tempo: One year
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One year
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Hospitalisation events
Lasso di tempo: One year
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Hospitalisation events coded as cerebro-vascular accident (CVA).
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One year
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Hospitalisation events
Lasso di tempo: One year
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Hospitalisation events coded as myocardial infarction.
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One year
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Hospitalisation events
Lasso di tempo: One year
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Hospitalisation events coded as Coronary revascularisation. This analysis will involve a pre-specified subgroup analysis of:
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One year
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Collaboratori e investigatori
Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.
Collaboratori
Investigatori
- Investigatore principale: Nicholas Curzen, BM PhD FRCP, University Hospital Southampton NHS Foundation Trust
- Investigatore principale: Rod H Stables, MA, DM, BM BCH, FRCP, Liverpool Heart and Chest Hospital NHS Foundation Trust
Pubblicazioni e link utili
La persona responsabile dell'inserimento delle informazioni sullo studio fornisce volontariamente queste pubblicazioni. Questi possono riguardare qualsiasi cosa relativa allo studio.
Pubblicazioni generali
- Tonino PA, De Bruyne B, Pijls NH, Siebert U, Ikeno F, van' t Veer M, Klauss V, Manoharan G, Engstrom T, Oldroyd KG, Ver Lee PN, MacCarthy PA, Fearon WF; FAME Study Investigators. Fractional flow reserve versus angiography for guiding percutaneous coronary intervention. N Engl J Med. 2009 Jan 15;360(3):213-24. doi: 10.1056/NEJMoa0807611.
- De Bruyne B, Pijls NH, Kalesan B, Barbato E, Tonino PA, Piroth Z, Jagic N, Mobius-Winkler S, Rioufol G, Witt N, Kala P, MacCarthy P, Engstrom T, Oldroyd KG, Mavromatis K, Manoharan G, Verlee P, Frobert O, Curzen N, Johnson JB, Juni P, Fearon WF; FAME 2 Trial Investigators. Fractional flow reserve-guided PCI versus medical therapy in stable coronary disease. N Engl J Med. 2012 Sep 13;367(11):991-1001. doi: 10.1056/NEJMoa1205361. Epub 2012 Aug 27. Erratum In: N Engl J Med. 2012 Nov;367(18):1768. Mobius-Winckler, Sven [corrected to Mobius-Winkler, Sven].
- De Bruyne B, Baudhuin T, Melin JA, Pijls NH, Sys SU, Bol A, Paulus WJ, Heyndrickx GR, Wijns W. Coronary flow reserve calculated from pressure measurements in humans. Validation with positron emission tomography. Circulation. 1994 Mar;89(3):1013-22. doi: 10.1161/01.cir.89.3.1013.
- Berger A, Botman KJ, MacCarthy PA, Wijns W, Bartunek J, Heyndrickx GR, Pijls NH, De Bruyne B. Long-term clinical outcome after fractional flow reserve-guided percutaneous coronary intervention in patients with multivessel disease. J Am Coll Cardiol. 2005 Aug 2;46(3):438-42. doi: 10.1016/j.jacc.2005.04.041.
- Pijls NH, De Bruyne B, Peels K, Van Der Voort PH, Bonnier HJ, Bartunek J Koolen JJ, Koolen JJ. Measurement of fractional flow reserve to assess the functional severity of coronary-artery stenoses. N Engl J Med. 1996 Jun 27;334(26):1703-8. doi: 10.1056/NEJM199606273342604.
- Pijls NH, van Schaardenburgh P, Manoharan G, Boersma E, Bech JW, van't Veer M, Bar F, Hoorntje J, Koolen J, Wijns W, de Bruyne B. Percutaneous coronary intervention of functionally nonsignificant stenosis: 5-year follow-up of the DEFER Study. J Am Coll Cardiol. 2007 May 29;49(21):2105-11. doi: 10.1016/j.jacc.2007.01.087. Epub 2007 May 17.
- Thygesen K, Alpert JS, Jaffe AS, Simoons ML, Chaitman BR, White HD; Writing Group on behalf of the Joint ESC/ACCF/AHA/WHF Task Force for the Universal Definition of Myocardial Infarction. Third universal definition of myocardial infarction. Glob Heart. 2012 Dec;7(4):275-95. doi: 10.1016/j.gheart.2012.08.001. Epub 2012 Sep 26. No abstract available.
- White CW, Wright CB, Doty DB, Hiratza LF, Eastham CL, Harrison DG, Marcus ML. Does visual interpretation of the coronary arteriogram predict the physiologic importance of a coronary stenosis? N Engl J Med. 1984 Mar 29;310(13):819-24. doi: 10.1056/NEJM198403293101304.
- Curzen N, Rana O, Nicholas Z, Golledge P, Zaman A, Oldroyd K, Hanratty C, Banning A, Wheatcroft S, Hobson A, Chitkara K, Hildick-Smith D, McKenzie D, Calver A, Dimitrov BD, Corbett S. Does routine pressure wire assessment influence management strategy at coronary angiography for diagnosis of chest pain?: the RIPCORD study. Circ Cardiovasc Interv. 2014 Apr;7(2):248-55. doi: 10.1161/CIRCINTERVENTIONS.113.000978. Epub 2014 Mar 18.
- Pijls NH, Fearon WF, Tonino PA, Siebert U, Ikeno F, Bornschein B, van't Veer M, Klauss V, Manoharan G, Engstrom T, Oldroyd KG, Ver Lee PN, MacCarthy PA, De Bruyne B; FAME Study Investigators. Fractional flow reserve versus angiography for guiding percutaneous coronary intervention in patients with multivessel coronary artery disease: 2-year follow-up of the FAME (Fractional Flow Reserve Versus Angiography for Multivessel Evaluation) study. J Am Coll Cardiol. 2010 Jul 13;56(3):177-84. doi: 10.1016/j.jacc.2010.04.012. Epub 2010 May 28.
- Toth G, Hamilos M, Pyxaras S, Mangiacapra F, Nelis O, De Vroey F, Di Serafino L, Muller O, Van Mieghem C, Wyffels E, Heyndrickx GR, Bartunek J, Vanderheyden M, Barbato E, Wijns W, De Bruyne B. Evolving concepts of angiogram: fractional flow reserve discordances in 4000 coronary stenoses. Eur Heart J. 2014 Oct 21;35(40):2831-8. doi: 10.1093/eurheartj/ehu094. Epub 2014 Mar 18.
- Zir LM, Miller SW, Dinsmore RE, Gilbert JP, Harthorne JW. Interobserver variability in coronary angiography. Circulation. 1976 Apr;53(4):627-32. doi: 10.1161/01.cir.53.4.627.
- Longman K, Curzen N. Should ischemia be the main target in selecting a percutaneous coronary intervention strategy? Expert Rev Cardiovasc Ther. 2013 Aug;11(8):1051-9. doi: 10.1586/14779072.2013.814856.
- Weintraub WS, Mahoney EM, Zhang Z, Chu H, Hutton J, Buxton M, Booth J, Nugara F, Stables RH, Dooley P, Collinson J, Stuteville M, Delahunty N, Wright A, Flather MD, De Cock E. One year comparison of costs of coronary surgery versus percutaneous coronary intervention in the stent or surgery trial. Heart. 2004 Jul;90(7):782-8. doi: 10.1136/hrt.2003.015057.
- Zhang Z, Mahoney EM, Stables RH, Booth J, Nugara F, Spertus JA, Weintraub WS. Disease-specific health status after stent-assisted percutaneous coronary intervention and coronary artery bypass surgery: one-year results from the Stent or Surgery trial. Circulation. 2003 Oct 7;108(14):1694-700. doi: 10.1161/01.CIR.0000087600.83707.FD. Epub 2003 Sep 15.
- SoS Investigators. Coronary artery bypass surgery versus percutaneous coronary intervention with stent implantation in patients with multivessel coronary artery disease (the Stent or Surgery trial): a randomised controlled trial. Lancet. 2002 Sep 28;360(9338):965-70. doi: 10.1016/S0140-6736(02)11078-6.
- Van Belle E, Rioufol G, Pouillot C, Cuisset T, Bougrini K, Teiger E, Champagne S, Belle L, Barreau D, Hanssen M, Besnard C, Dauphin R, Dallongeville J, El Hahi Y, Sideris G, Bretelle C, Lhoest N, Barnay P, Leborgne L, Dupouy P; Investigators of the Registre Francais de la FFR-R3F. Outcome impact of coronary revascularization strategy reclassification with fractional flow reserve at time of diagnostic angiography: insights from a large French multicenter fractional flow reserve registry. Circulation. 2014 Jan 14;129(2):173-85. doi: 10.1161/CIRCULATIONAHA.113.006646. Epub 2013 Nov 19.
- Henderson R, Lee L. The epidemiology and pathophysiology of coronary artery disease. Chapter 1 in The Oxford Textbook of Interventional Cardiology. Eds: Redwood, Curzen, Thomas. Oxford University Press 2010.
- Muller O, De Bruyne B. Coronary physiology in clinical practice. Chapter 9 in in The Oxford Book of Interventional Cardiology. Eds: Redwood, Curzen, Thomas. Oxford University Press 2010.
- Chest Pain of Recent Onset. NICE Guidance CG95, 2010. https://www.nice.org.uk/guidance/CG95
- Elguindy M, Stables R, Nicholas Z, Kemp I, Curzen N. Design and Rationale of the RIPCORD 2 Trial (Does Routine Pressure Wire Assessment Influence Management Strategy at Coronary Angiography for Diagnosis of Chest Pain?): A Randomized Controlled Trial to Compare Routine Pressure Wire Assessment With Conventional Angiography in the Management of Patients With Coronary Artery Disease. Circ Cardiovasc Qual Outcomes. 2018 Feb;11(2):e004191. doi: 10.1161/CIRCOUTCOMES.117.004191.
Studiare le date dei record
Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.
Studia le date principali
Inizio studio
1 settembre 2016
Completamento primario (Anticipato)
1 dicembre 2019
Completamento dello studio (Anticipato)
1 marzo 2020
Date di iscrizione allo studio
Primo inviato
6 luglio 2016
Primo inviato che soddisfa i criteri di controllo qualità
1 settembre 2016
Primo Inserito (Stima)
8 settembre 2016
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
12 agosto 2019
Ultimo aggiornamento inviato che soddisfa i criteri QC
8 agosto 2019
Ultimo verificato
1 agosto 2019
Maggiori informazioni
Termini relativi a questo studio
Termini MeSH pertinenti aggiuntivi
- Processi patologici
- Malattie cardiache
- Malattia cardiovascolare
- Malattie vascolari
- Arteriosclerosi
- Malattie arteriose occlusive
- Dolore
- Manifestazioni neurologiche
- Patologia
- Angina pectoris
- Disfunsione dell'arteria coronaria
- Ischemia miocardica
- Malattia coronarica
- Sindrome
- Dolore al petto
- Sindrome coronarica acuta
- Angina, Stabile
Altri numeri di identificazione dello studio
- RHM CAR0498
Piano per i dati dei singoli partecipanti (IPD)
Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?
NO
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .