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?

NCT02892903 | Unknown DMC

• 1 other identifier: RHM CAR0498
• Study Type: interventional
• Target: 1,100
• Locations: 1 country
• Sites: 17

Brief Summary

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).

Conditions

Chest Pain; Stable Angina; Acute Coronary Syndrome; Non ST Segment Elevation Acute Coronary Syndrome

Keywords

Fractional flow reserve (FFR); Pressure wire (PW); Coronary angiography

Outcome Measures

Primary Outcomes (2)

• Primary Economic Outcome Measure

  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.

  One year

• Primary Quality of Life Outcome Measure

  Patient reported quality of life at one year using the EQ-5D health questionnaire.

  One year

Secondary Outcomes (10)

• Management strategy information

  Reported once: Single declaration at index procedure after randomisation

• Management strategy information

  Reported once: Single declaration at index procedure after randomisation

• Angina symptoms

  One year

• Angina symptoms

  One year

• All-cause mortality

  One year

Study Arms (2)

Conventional angiography

NO INTERVENTION

Routine angiography will be performed according to local best practice

Routine Measurement of FFR

EXPERIMENTAL

Additional investigation with the measurement of FFR in all major vessels

Device: Routine Measurement of FFR

Interventions

Routine Measurement of FFR DEVICE

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

Also known as: Pressure wire assessment

Routine Measurement of FFR

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• 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.

You may not qualify if:

• ≤ 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

Sponsors & Collaborators

• University Hospital Southampton NHS Foundation Trust: lead
• Liverpool Heart and Chest Hospital NHS Foundation Trust: collaborator

Study Sites (17)

Royal Bournemouth Hospital - The Royal Bournemouth and Christchurch Hospitals NHS Foundation Trust

Bournemouth, Dorset, BH7 7DW, United Kingdom

Location

Brighton and Sussex University Hospitals NHS Trust

Brighton, East Sussex, BN2 5BE, United Kingdom

Location

Queen Alexandra Hospital - Portsmouth Hospitals NHS Trust

Portsmouth, Hampshire, PO6 3LY, United Kingdom

Location

Southampton General Hospital - University Hospitals Southampton NHS Foundation Trust

Southampton, Hampshire, SO16 6YD, United Kingdom

Location

Royal Blackburn Teaching Hospital - East Lancashire Hospitals NHS Trust

Blackburn, Lancashire, BB2 3HH, United Kingdom

Location

Liverpool Heart and Chest Hospital NHS Foundation Trust

Liverpool, Merseyside, L14 3PE, United Kingdom

Location

Freeman Hospital - Newcastle Hospitals

Newcastle upon Tyne, Northumberland, NE7 7DN, United Kingdom

Location

King's Mill Hospital - Sherwood Forest Hospitals NHS Foundation Trust

Mansfield, Nottinghamshire, NG17 4JL, United Kingdom

Location

City Hospital - Nottingham University Hospitals NHS Trust

Nottingham, Nottinghamshire, NG5 1PB, United Kingdom

Location

Golden Jubilee National Hospital

Glasgow, Scotland, G81 4DY, United Kingdom

Location

Northern General Hospital - Sheffield Teaching Hospitals

Sheffield, South Yorkshire, S5 7AU, United Kingdom

Location

Royal Stoke University Hospital - University Hospitals of North Midlands

Stoke-on-Trent, Staffordshire, ST4 6QG, United Kingdom

Location

Queen Elizabeth Hospital - University Hospitals Birmingham NHS Foundation Trust

Birmingham, West Midlands, B15 2TH, United Kingdom

Location

Pinderfields Hospital - The Mid Yorkshire Hospitals NHS Trust

Wakefield, West Yorkshire, WF1 4DG, United Kingdom

Location

Castle Hill Hospital - Hull and East Yorkshire Hospitals NHS Trust

Hull, Yorkshire, HU16 5JQ, United Kingdom

Location

Leeds General Infirmary - Leeds Teaching Hospitals NHS Trust

Leeds, Yorkshire, LS1 3EX, United Kingdom

Location

Bristol Heart Institute - University Hospitals Bristol NHS Foundation Trust

Bristol, BS2 8HW, United Kingdom

Location

Related Publications (21)

• 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.

  PMID: 1253383 BACKGROUND

• 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.

  PMID: 6700670 BACKGROUND

• 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.

  PMID: 8124786 BACKGROUND

• 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.

  PMID: 8637515 BACKGROUND

• 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.

  PMID: 16053955 BACKGROUND

• 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.

  PMID: 19144937 BACKGROUND

• 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.

  PMID: 17531660 BACKGROUND

• 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.

  PMID: 20537493 BACKGROUND

• 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.

  PMID: 22924638 BACKGROUND

• 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.

  PMID: 23984928 BACKGROUND

• 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.

  PMID: 24644308 BACKGROUND

• 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.

  PMID: 24642999 BACKGROUND

• 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.

  PMID: 25689940 BACKGROUND

• 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.

  PMID: 15201249 BACKGROUND

• 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.

  PMID: 12975252 BACKGROUND

• 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.

  PMID: 12383664 BACKGROUND

• 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.

  PMID: 24255062 BACKGROUND

• 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.

  BACKGROUND

• 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.

  BACKGROUND

• Chest Pain of Recent Onset. NICE Guidance CG95, 2010. https://www.nice.org.uk/guidance/CG95

  BACKGROUND

• 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.

  PMID: 29449442 DERIVED

MeSH Terms

Conditions

Chest Pain; Angina, Stable; Acute Coronary Syndrome

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Angina Pectoris; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases

Study Officials

• Nicholas Curzen, BM PhD FRCP

  University Hospital Southampton NHS Foundation Trust

  PRINCIPAL INVESTIGATOR

• Rod H Stables, MA, DM, BM BCH, FRCP

  Liverpool Heart and Chest Hospital NHS Foundation Trust

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 6, 2016
• First Posted: September 8, 2016
• Study Start: September 1, 2016
• Primary Completion: December 1, 2019
• Study Completion: March 1, 2020
• Last Updated: August 12, 2019

Record last verified: 2019-08

Data Sharing

• IPD Sharing: Will not share

Locations

GB (17)