Clinical trial NCT02892903: 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?
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 type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
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
Lead sponsor: University Hospital Southampton NHS Foundation Trust
Sponsor class: OTHER
Collaborators: name: Liverpool Heart and Chest Hospital NHS Foundation Trust
First posted: 2016-09-08
Enrollment: 1100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

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).

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.

Eligibility 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)

Primary outcomes:
measure: Primary Economic Outcome Measure
timeFrame: One year
measure: Primary Quality of Life Outcome Measure
timeFrame: One year
Secondary outcomes:
measure: Management strategy information
timeFrame: Reported once: Single declaration at index procedure after randomisation
measure: Management strategy information
timeFrame: Reported once: Single declaration at index procedure after randomisation
measure: Angina symptoms
timeFrame: One year
measure: Angina symptoms
timeFrame: One year
measure: All-cause mortality
timeFrame: One year
measure: Number of hospitalisation events
timeFrame: One year
measure: Total hospital days
timeFrame: One year
measure: Hospitalisation events
timeFrame: One year
measure: Hospitalisation events
timeFrame: One year
measure: Hospitalisation events
timeFrame: One year
Other outcomes:
Locations:
city: Bournemouth
country: United Kingdom
facility: Royal Bournemouth Hospital - The Royal Bournemouth and Christchurch Hospitals NHS Foundation Trust
state: Dorset
city: Brighton
country: United Kingdom
facility: Brighton and Sussex University Hospitals NHS Trust
state: East Sussex
city: Portsmouth
country: United Kingdom
facility: Queen Alexandra Hospital - Portsmouth Hospitals NHS Trust
state: Hampshire
city: Southampton
country: United Kingdom
facility: Southampton General Hospital - University Hospitals Southampton NHS Foundation Trust
state: Hampshire
city: Blackburn
country: United Kingdom
facility: Royal Blackburn Teaching Hospital - East Lancashire Hospitals NHS Trust
state: Lancashire
city: Liverpool
country: United Kingdom
facility: Liverpool Heart and Chest Hospital NHS Foundation Trust
state: Merseyside
city: Newcastle upon Tyne
country: United Kingdom
facility: Freeman Hospital - Newcastle Hospitals
state: Northumberland
city: Mansfield
country: United Kingdom
facility: King's Mill Hospital - Sherwood Forest Hospitals NHS Foundation Trust
state: Nottinghamshire
city: Nottingham
country: United Kingdom
facility: City Hospital - Nottingham University Hospitals NHS Trust
state: Nottinghamshire
city: Glasgow
country: United Kingdom
facility: Golden Jubilee National Hospital
state: Scotland
city: Sheffield
country: United Kingdom
facility: Northern General Hospital - Sheffield Teaching Hospitals
state: South Yorkshire
city: Stoke-on-Trent
country: United Kingdom
facility: Royal Stoke University Hospital - University Hospitals of North Midlands
state: Staffordshire
city: Birmingham
country: United Kingdom
facility: Queen Elizabeth Hospital - University Hospitals Birmingham NHS Foundation Trust
state: West Midlands
city: Wakefield
country: United Kingdom
facility: Pinderfields Hospital - The Mid Yorkshire Hospitals NHS Trust
state: West Yorkshire
city: Hull
country: United Kingdom
facility: Castle Hill Hospital - Hull and East Yorkshire Hospitals NHS Trust
state: Yorkshire
city: Leeds
country: United Kingdom
facility: Leeds General Infirmary - Leeds Teaching Hospitals NHS Trust
state: Yorkshire
city: Bristol
country: United Kingdom
facility: Bristol Heart Institute - University Hospitals Bristol NHS Foundation Trust
Study officials:
affiliation: University Hospital Southampton NHS Foundation Trust
name: Nicholas Curzen, BM PhD FRCP
role: PRINCIPAL_INVESTIGATOR
affiliation: Liverpool Heart and Chest Hospital NHS Foundation Trust
name: Rod H Stables, MA, DM, BM BCH, FRCP
role: PRINCIPAL_INVESTIGATOR
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