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)

August 8, 2019 updated by: 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).

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

1100

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United Kingdom
      • Bristol, United Kingdom, BS2 8HW
        • Bristol Heart Institute - University Hospitals Bristol NHS Foundation Trust
    • Dorset
      • Bournemouth, Dorset, United Kingdom, BH7 7DW
        • Royal Bournemouth Hospital - The Royal Bournemouth and Christchurch Hospitals NHS Foundation Trust
    • East Sussex
      • Brighton, East Sussex, United Kingdom, BN2 5BE
        • Brighton and Sussex University Hospitals NHS Trust
    • Hampshire
      • Portsmouth, Hampshire, United Kingdom, PO6 3LY
        • Queen Alexandra Hospital - Portsmouth Hospitals NHS Trust
      • Southampton, Hampshire, United Kingdom, SO16 6YD
        • Southampton General Hospital - University Hospitals Southampton NHS Foundation Trust
    • Lancashire
      • Blackburn, Lancashire, United Kingdom, BB2 3HH
        • Royal Blackburn Teaching Hospital - East Lancashire Hospitals NHS Trust
    • Merseyside
      • Liverpool, Merseyside, United Kingdom, L14 3PE
        • Liverpool Heart and Chest Hospital NHS Foundation Trust
    • Northumberland
      • Newcastle upon Tyne, Northumberland, United Kingdom, NE7 7DN
        • Freeman Hospital - Newcastle Hospitals
    • Nottinghamshire
      • Mansfield, Nottinghamshire, United Kingdom, NG17 4JL
        • King's Mill Hospital - Sherwood Forest Hospitals NHS Foundation Trust
      • Nottingham, Nottinghamshire, United Kingdom, NG5 1PB
        • City Hospital - Nottingham University Hospitals NHS Trust
    • Scotland
      • Glasgow, Scotland, United Kingdom, G81 4DY
        • Golden Jubilee National Hospital
    • South Yorkshire
      • Sheffield, South Yorkshire, United Kingdom, S5 7AU
        • Northern General Hospital - Sheffield Teaching Hospitals
    • Staffordshire
      • Stoke-on-Trent, Staffordshire, United Kingdom, ST4 6QG
        • Royal Stoke University Hospital - University Hospitals of North Midlands
    • West Midlands
      • Birmingham, West Midlands, United Kingdom, B15 2TH
        • Queen Elizabeth Hospital - University Hospitals Birmingham NHS Foundation Trust
    • West Yorkshire
      • Wakefield, West Yorkshire, United Kingdom, WF1 4DG
        • Pinderfields Hospital - The Mid Yorkshire Hospitals NHS Trust
    • Yorkshire
      • Hull, Yorkshire, United Kingdom, HU16 5JQ
        • Castle Hill Hospital - Hull and East Yorkshire Hospitals NHS Trust
      • Leeds, Yorkshire, United Kingdom, LS1 3EX
        • Leeds General Infirmary - Leeds Teaching Hospitals NHS Trust

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

· 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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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 Names:
  • Pressure wire assessment

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
All-cause mortality
Time Frame: One year
One year
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.
Reported once: Single declaration at index procedure after randomisation
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.
Reported once: Single declaration at index procedure after randomisation
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.
One year
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.
One year
Number of hospitalisation events
Time Frame: One year
One year
Total hospital days
Time Frame: One year
One year
Hospitalisation events
Time Frame: One year
Hospitalisation events coded as cerebro-vascular accident (CVA).
One year
Hospitalisation events
Time Frame: One year
Hospitalisation events coded as myocardial infarction.
One year
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.
One year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital Southampton NHS Foundation Trust

Collaborators

Liverpool Heart and Chest Hospital NHS Foundation Trust

Investigators

  • 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 and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2016

Primary Completion (Anticipated)

December 1, 2019

Study Completion (Anticipated)

March 1, 2020

Study Registration Dates

First Submitted

July 6, 2016

First Submitted That Met QC Criteria

September 1, 2016

First Posted (Estimate)

September 8, 2016

Study Record Updates

Last Update Posted (Actual)

August 12, 2019

Last Update Submitted That Met QC Criteria

August 8, 2019

Last Verified

August 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RHM CAR0498

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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