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?

NCT ID: NCT02892903

Last Updated: 2019-08-12

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 1100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-09-30
• Study Completion Date: 2020-03-31

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.

Conditions

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

Conventional angiography

Routine angiography will be performed according to local best practice

Group Type: NO_INTERVENTION

No interventions assigned to this group

Routine Measurement of FFR

Additional investigation with the measurement of FFR in all major vessels

Group Type: EXPERIMENTAL

Routine Measurement of FFR

Intervention Type: 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

Interventions

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

Intervention Type: DEVICE

Other Intervention Names

Pressure wire assessment

Eligibility Criteria

Inclusion Criteria

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.

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

• 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)

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Liverpool Heart and Chest Hospital NHS Foundation Trust

OTHER

Sponsor Role: collaborator

University Hospital Southampton NHS Foundation Trust

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Nicholas Curzen, BM PhD FRCP

Role: PRINCIPAL_INVESTIGATOR

University Hospital Southampton NHS Foundation Trust

Rod H Stables, MA, DM, BM BCH, FRCP

Role: PRINCIPAL_INVESTIGATOR

Liverpool Heart and Chest Hospital NHS Foundation Trust

Locations

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

Bournemouth, Dorset, United Kingdom

Brighton and Sussex University Hospitals NHS Trust

Brighton, East Sussex, United Kingdom

Queen Alexandra Hospital - Portsmouth Hospitals NHS Trust

Portsmouth, Hampshire, United Kingdom

Southampton General Hospital - University Hospitals Southampton NHS Foundation Trust

Southampton, Hampshire, United Kingdom

Royal Blackburn Teaching Hospital - East Lancashire Hospitals NHS Trust

Blackburn, Lancashire, United Kingdom

Liverpool Heart and Chest Hospital NHS Foundation Trust

Liverpool, Merseyside, United Kingdom

Freeman Hospital - Newcastle Hospitals

Newcastle upon Tyne, Northumberland, United Kingdom

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

Mansfield, Nottinghamshire, United Kingdom

City Hospital - Nottingham University Hospitals NHS Trust

Nottingham, Nottinghamshire, United Kingdom

Golden Jubilee National Hospital

Glasgow, Scotland, United Kingdom

Northern General Hospital - Sheffield Teaching Hospitals

Sheffield, South Yorkshire, United Kingdom

Royal Stoke University Hospital - University Hospitals of North Midlands

Stoke-on-Trent, Staffordshire, United Kingdom

Queen Elizabeth Hospital - University Hospitals Birmingham NHS Foundation Trust

Birmingham, West Midlands, United Kingdom

Pinderfields Hospital - The Mid Yorkshire Hospitals NHS Trust

Wakefield, West Yorkshire, United Kingdom

Castle Hill Hospital - Hull and East Yorkshire Hospitals NHS Trust

Hull, Yorkshire, United Kingdom

Leeds General Infirmary - Leeds Teaching Hospitals NHS Trust

Leeds, Yorkshire, United Kingdom

Bristol Heart Institute - University Hospitals Bristol NHS Foundation Trust

Bristol, , United Kingdom

Countries

United Kingdom

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Other Identifiers

RHM CAR0498

Identifier Type: -

Identifier Source: org_study_id