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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)

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ClinicalTrials.gov Identifier: NCT02892903
Recruitment Status : Recruiting
First Posted : September 8, 2016
Last Update Posted : April 8, 2019
Sponsor:
Collaborator:
Liverpool Heart and Chest Hospital NHS Foundation Trust
Information provided by (Responsible Party):
University Hospital Southampton NHS Foundation Trust

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).

Condition or disease Intervention/treatment Phase
Chest Pain Stable Angina Acute Coronary Syndrome Non ST Segment Elevation Acute Coronary Syndrome Device: Routine Measurement of FFR Not Applicable

Detailed Description:
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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 1100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: A Randomised Controlled Trial to Compare Routine Pressure Wire Assessment With Conventional Angiography in the Management of Patients With Coronary Artery Disease.
Study Start Date : September 2016
Estimated Primary Completion Date : December 2019
Estimated Study Completion Date : March 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
No Intervention: Conventional angiography
Routine angiography will be performed according to local best practice
Experimental: Routine Measurement of FFR
Additional investigation with the measurement of FFR in all major vessels
Device: Routine Measurement of FFR
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
Other Name: Pressure wire assessment




Primary Outcome Measures :
  1. Primary Economic Outcome Measure [ Time Frame: One year ]
    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.

  2. Primary Quality of Life Outcome Measure [ Time Frame: One year ]
    Patient reported quality of life at one year using the EQ-5D health questionnaire.


Secondary Outcome Measures :
  1. Management strategy information [ Time Frame: Reported once: Single declaration at index procedure after randomisation ]
    · Proportion of vessels deemed to demonstrate flow-limiting disease and targeted for revascularisation in the declared initial management strategy.

  2. Management strategy information [ Time Frame: Reported once: Single declaration at index procedure after randomisation ]
    · 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.

  3. Angina symptoms [ Time Frame: One year ]
    • Angina symptoms as reported by the research team after the 12 month contact, described by Canadian Cardiovascular Society Grade.

  4. Angina symptoms [ Time Frame: One year ]
    • Angina symptoms as reported by the patient with private completion of a screening form at 12 months, described by Canadian Cardiovascular Society Grade.

  5. All-cause mortality [ Time Frame: One year ]
  6. Number of hospitalisation events [ Time Frame: One year ]
  7. Total hospital days [ Time Frame: One year ]
  8. Hospitalisation events [ Time Frame: One year ]
    Hospitalisation events coded as cerebro-vascular accident (CVA).

  9. Hospitalisation events [ Time Frame: One year ]
    Hospitalisation events coded as myocardial infarction.

  10. Hospitalisation events [ Time Frame: One year ]

    Hospitalisation events coded as Coronary revascularisation. This analysis will involve a pre-specified subgroup analysis of:

    • Planned revascularisation - if declared as the index strategy.
    • All additional revascularisation events.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

· 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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02892903


Contacts
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Contact: Rodney H Stables, MA, DM, BM BCH, FRCP +44 151 600 1489 rod.stables@lhch.nhs.uk
Contact: Mostafa M Elguindy, MBChB, MSc +44 0151 254 3040 mostafa.elguindy@lhch.nhs.uk

Locations
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United Kingdom
Royal Bournemouth Hospital - The Royal Bournemouth and Christchurch Hospitals NHS Foundation Trust Recruiting
Bournemouth, Dorset, United Kingdom, BH7 7DW
Contact: Stephanie Horler    0120 270 4514    Cardiac.Research@rbch.nhs.uk   
Principal Investigator: Peter O'Kane, BSc MBBS MRCP MD         
Brighton and Sussex University Hospitals NHS Trust Recruiting
Brighton, East Sussex, United Kingdom, BN2 5BE
Contact: Nicola Skipper    01273 696955 ext 63861/4049    Nicola.skipper@bsuh.nhs.uk   
Contact: Andrew MsGreggor    01273 696955 ext 64049    andrew.mcgregor@bsuh.nhs.uk   
Principal Investigator: David Hildick-Smith, MD, FRCP, FSCAI         
Queen Alexandra Hospital - Portsmouth Hospitals NHS Trust Recruiting
Portsmouth, Hampshire, United Kingdom, PO6 3LY
Contact: Anna Cunnington    0239 228 6000 ext 3876    Anna.Cunnington@porthosp.nhs.uk   
Contact: Serena Howe    0239 228 6000 ext 3295    Serena.Howe2@porthosp.nhs.uk   
Principal Investigator: Alexander Hobson, FRCP MBBS BSc MD         
Southampton General Hospital - University Hospitals Southampton NHS Foundation Trust Recruiting
Southampton, Hampshire, United Kingdom, SO16 6YD
Contact: Zoe Nicholas    0238 120 8538    zoe.nicholas@uhs.nhs.uk   
Contact: Sam Gough    0238 120 8538    Sam.Gough@uhs.nhs.uk   
Principal Investigator: Nicholas Curzen, BM PhD FRCP         
Royal Blackburn Teaching Hospital - East Lancashire Hospitals NHS Trust Recruiting
Blackburn, Lancashire, United Kingdom, BB2 3HH
Contact: Karen N Davies    +44 01254 732649 ext 82649    karen.davies2@elht.nhs.uk   
Contact: Hawa Desai    +44 01254 732649    hawa.desai@elht.nhs.uk   
Principal Investigator: Scot Garg, MBChB, MRCP, PhD (Hons), FESC         
Liverpool Heart and Chest Hospital NHS Foundation Trust Recruiting
Liverpool, Merseyside, United Kingdom, L14 3PE
Contact: Janet Barton    01516001672    Janet.Barton@lhch.nhs.uk   
Principal Investigator: Rodney H Stables, MA, DM, BM BCH, FRCP         
Freeman Hospital - Newcastle Hospitals Recruiting
Newcastle upon Tyne, Northumberland, United Kingdom, NE7 7DN
Contact: Samantha Jones    0191 2448939    Samantha.Jones@nuth.nhs.uk   
Principal Investigator: Azfar Zaman, BSc, MBChB, MD, FRCP         
King's Mill Hospital - Sherwood Forest Hospitals NHS Foundation Trust Recruiting
Mansfield, Nottinghamshire, United Kingdom, NG17 4JL
Contact: Sarah Shelton    01623 622515 ext 6304    Sarah.Shelton@sfh-tr.nhs.uk   
Contact: Lynne Allsop    01623 622515 ext 3990    lynne.allsop@sfh-tr.nhs.uk   
Principal Investigator: Aftab Jan, MBBS, MRCP         
City Hospital - Nottingham University Hospitals NHS Trust Recruiting
Nottingham, Nottinghamshire, United Kingdom, NG5 1PB
Contact: Jane Burton    0115 9691169    jane.burton@nuh.nhs.uk   
Principal Investigator: Sachin Jadhav, MBChB(Hons) MD FRCP(glasg)         
Golden Jubilee National Hospital Recruiting
Glasgow, Scotland, United Kingdom, G81 4DY
Contact: Joanne Kelly    0141 951 5176    joanne.kelly@goldenjubilee.scot.nhs.uk   
Contact: Anna O'Donnell    0141 951 4701    anna.odonnell@goldenjubilee.scot.nhs.uk   
Principal Investigator: Colin Berry, BSc, MB.ChB, PhD, FRCP, FACC         
Northern General Hospital - Sheffield Teaching Hospitals Recruiting
Sheffield, South Yorkshire, United Kingdom, S5 7AU
Contact: Janet Middle    +44 11427 15779 ext 15779    janet.middle@sth.nhs.uk   
Contact: Shay Willoughby    +44 11427 15779    shay.willoughby@sth.nhs.uk   
Principal Investigator: Julian Gunn, MA MB BChir MD MRCP         
Royal Stoke University Hospital - University Hospitals of North Midlands Recruiting
Stoke-on-Trent, Staffordshire, United Kingdom, ST4 6QG
Contact: Jane Delaney    01782 672779    jane.delaney@uhnm.nhs.uk   
Contact: Ian Massey       ian.massey@uhnm.nhs.uk   
Principal Investigator: Mamas Mamas, BM BCh, MA, DPhil, MRCP         
Queen Elizabeth Hospital - University Hospitals Birmingham NHS Foundation Trust Recruiting
Birmingham, West Midlands, United Kingdom, B15 2TH
Contact: Annette Nilsson    01213714624    annette.nilsson@uhb.nhs.uk   
Principal Investigator: Sohail Khan, BSc (Hons), MB ChB, MD, MRCP         
Pinderfields Hospital - The Mid Yorkshire Hospitals NHS Trust Recruiting
Wakefield, West Yorkshire, United Kingdom, WF1 4DG
Contact: Donna Exley    01924 541808    donna.exley@midyorks.nhs.uk   
Contact: Judith Wright    01924 541808    Judith.Wright2@midyorks.nhs.uk   
Principal Investigator: Dwayne Conway, MD, MRCP         
Castle Hill Hospital - Hull and East Yorkshire Hospitals NHS Trust Recruiting
Hull, Yorkshire, United Kingdom, HU16 5JQ
Contact: Lisa Chaytor    01482 626767    lisa.chaytor@hey.nhs.uk   
Principal Investigator: Angela Hoye, MB ChB, PhD         
Leeds General Infirmary - Leeds Teaching Hospitals NHS Trust Recruiting
Leeds, Yorkshire, United Kingdom, LS1 3EX
Contact: Kathryn Somers    0113 3928483    kathryn.somers@nhs.net   
Principal Investigator: Stephen Wheatcroft, BS(Hons) MBChB(Hons) PhD FRCP         
Bristol Heart Institute - University Hospitals Bristol NHS Foundation Trust Recruiting
Bristol, United Kingdom, BS2 8HW
Contact: Isobel Sullivan    0117 342 1141 ext 6938    isobel.sullivan@uhbristol.nhs.uk   
Contact: Ruth Bowles       ruth.bowles@uhbristol.nhs.uk   
Principal Investigator: Thomas Johnson, BSc MBBS MRCP MD         
Sponsors and Collaborators
University Hospital Southampton NHS Foundation Trust
Liverpool Heart and Chest Hospital NHS Foundation Trust
Investigators
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Principal Investigator: 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

Publications:
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

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: University Hospital Southampton NHS Foundation Trust
ClinicalTrials.gov Identifier: NCT02892903     History of Changes
Other Study ID Numbers: RHM CAR0498
First Posted: September 8, 2016    Key Record Dates
Last Update Posted: April 8, 2019
Last Verified: January 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by University Hospital Southampton NHS Foundation Trust:
Fractional flow reserve (FFR)
Pressure wire (PW)
Coronary angiography

Additional relevant MeSH terms:
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Syndrome
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Acute Coronary Syndrome
Chest Pain
Angina, Stable
Disease
Pathologic Processes
Heart Diseases
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Pain
Neurologic Manifestations
Signs and Symptoms
Angina Pectoris