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?

Not Applicable

• Conditions: Chest Pain; Non ST Segment Elevation Acute Coronary Syndrome; Stable Angina; Acute Coronary Syndrome
• Interventions: Device: Routine Measurement of FFR

• Registration Number: NCT02892903
• Lead Sponsor: University Hospital Southampton NHS Foundation Trust

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.

Study Timeline

• Study First Submitted: 2016-07-06
• Study Start: 2016-09
• Study First Submitted QC: 2016-09-01
• Study First Posted: 2016-09-08
• Status Verified: 2019-08
• Last Update Submitted: 2019-08-08
• Last Update Posted: 2019-08-12
• Primary Completion: 2019-12
• Study Completion: 2020-03

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 1100

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Routine Measurement of FFR	Routine Measurement of FFR	Additional investigation with the measurement of FFR in all major vessels

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Total hospital days	One year
Management strategy information	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.
Angina symptoms	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.
All-cause mortality	One year
Number of hospitalisation events	One year
Hospitalisation events	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.

Trial Locations

Locations (17)

Royal Bournemouth Hospital - The Royal Bournemouth and Christchurch Hospitals NHS Foundation Trust; 🇬🇧 Bournemouth, Dorset, United Kingdom

Liverpool Heart and Chest Hospital NHS Foundation Trust; 🇬🇧 Liverpool, Merseyside, United Kingdom

Freeman Hospital - Newcastle Hospitals; 🇬🇧 Newcastle upon Tyne, Northumberland, United Kingdom

Northern General Hospital - Sheffield Teaching Hospitals; 🇬🇧 Sheffield, South Yorkshire, United Kingdom

Queen Elizabeth Hospital - University Hospitals Birmingham NHS Foundation Trust; 🇬🇧 Birmingham, West Midlands, United Kingdom

Castle Hill Hospital - Hull and East Yorkshire Hospitals NHS Trust; 🇬🇧 Hull, Yorkshire, United Kingdom

Pinderfields Hospital - The Mid Yorkshire Hospitals NHS Trust; 🇬🇧 Wakefield, West 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

Golden Jubilee National Hospital; 🇬🇧 Glasgow, Scotland, United Kingdom

King's Mill Hospital - Sherwood Forest Hospitals NHS Foundation Trust; 🇬🇧 Mansfield, Nottinghamshire, United Kingdom

Royal Blackburn Teaching Hospital - East Lancashire Hospitals NHS Trust; 🇬🇧 Blackburn, Lancashire, United Kingdom

Southampton General Hospital - University Hospitals Southampton NHS Foundation Trust; 🇬🇧 Southampton, Hampshire, 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

City Hospital - Nottingham University Hospitals NHS Trust; 🇬🇧 Nottingham, Nottinghamshire, United Kingdom

Royal Stoke University Hospital - University Hospitals of North Midlands; 🇬🇧 Stoke-on-Trent, Staffordshire, United Kingdom