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).
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
Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
NONE
Enrollment
1,100
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
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
...and 7 more locations
Primary Economic Outcome Measure
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.
Time frame: One year
Primary Quality of Life Outcome Measure
Patient reported quality of life at one year using the EQ-5D health questionnaire.
Time frame: One year
Management strategy information
· Proportion of vessels deemed to demonstrate flow-limiting disease and targeted for revascularisation in the declared initial management strategy.
Time frame: Reported once: Single declaration at index procedure after randomisation
Management strategy information
· 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.
Time frame: Reported once: Single declaration at index procedure after randomisation
Angina symptoms
• Angina symptoms as reported by the research team after the 12 month contact, described by Canadian Cardiovascular Society Grade.
Time frame: One year
Angina symptoms
• Angina symptoms as reported by the patient with private completion of a screening form at 12 months, described by Canadian Cardiovascular Society Grade.
Time frame: One year
All-cause mortality
Time frame: One year
Number of hospitalisation events
Time frame: One year
Total hospital days
Time frame: One year
Hospitalisation events
Hospitalisation events coded as cerebro-vascular accident (CVA).
Time frame: One year
Hospitalisation events
Hospitalisation events coded as myocardial infarction.
Time frame: One year
Hospitalisation events
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.
Time frame: One year
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