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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 : Unknown
Verified August 2019 by University Hospital Southampton NHS Foundation Trust.
Recruitment status was:  Active, not recruiting
First Posted : September 8, 2016
Last Update Posted : August 12, 2019
Sponsor:
Collaborator:
Liverpool Heart and Chest Hospital NHS Foundation Trust
Information provided by (Responsible Party):
University Hospital Southampton NHS Foundation Trust

Study Description
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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.
Study Design
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Study Type : Interventional  (Clinical Trial)
Actual 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


Arms and Interventions
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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


Outcome Measures
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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.


Eligibility Criteria
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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)
Contacts and Locations
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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


Locations
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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
More Information
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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    
Other Study ID Numbers: RHM CAR0498
First Posted: September 8, 2016    Key Record Dates
Last Update Posted: August 12, 2019
Last Verified: August 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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Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Acute Coronary Syndrome
Angina, Stable
Syndrome
Chest Pain
Disease
Pathologic Processes
 Heart Diseases
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Pain
Neurologic Manifestations
Angina Pectoris