Clinical trial NCT05028179: PROTEUS: Evaluating the Use of Artificial Intelligence to Support Stress Echocardiography Testing for Heart Disease
Official title: PROTEUS: A PROspective Randomised Controlled Trial Evaluating the Use of Artificial Intelligence in Stress Echocardiology
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Coronary Heart Disease
Lead sponsor: Ultromics Ltd
Sponsor class: INDUSTRY
Collaborators: name: University of Oxford
name: Academic Health Science Centres
name: National Institute for Health Research, United Kingdom
First posted: 2021-08-31
Enrollment: 2338
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: A multi-centre, two-arm, randomised controlled trial. Randomised 1:1

* Standard care group (comparator)
* Standard care plus AI platform (EchoGo)
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: PROTEUS is a multicentre, two arm, randomised controlled trial of a medical device to assess the impact of the introduction of EchoGo into the standard care pathway for stress echocardiology.

Detailed description: Title: A Prospective Randomised Controlled Trial Evaluating the Use of AI in Stress Echocardiography

Trial design: Multi-centre, two-arm, Randomised Controlled Trial of a medical device. Randomised 1:1 to either:

* Standard care (comparator), or
* Standard care plus AI Platform (EchoGo) Trial participants: Adults undergoing clinically indicated stress echocardiogram (SE) to assess inducible ischaemia at participating NHS Trusts.

Having benchmarked the device performance (Upton 2019), and having successfully deployed and tested the required infrastructure, we now propose to prospectively test the software in clinical practice. Based on the existing data for accuracy we would expect use of the EchoGo Platform in the clinical pathway will have a significant benefit reducing inter-reader variability, increasing accuracy and thereby reducing health costs. To formally evaluate the impact of automated AI quantification and accuracy of the decision to make a referral to coronary angiogram, following stress echocardiography, we propose a prospective, multi-centre, randomised controlled trial that compares provision of an AI derived report to a clinician against clinician-only standard of care. This will provide the highest level of evidence of any potential benefit or disadvantages prior to adoption of the software for widespread clinical implementation.

Eligibility criteria: Inclusion Criteria:

* Willing and able to provide informed consent
* Male or female, ≥18 years of age at study entry
* Referred to an NHS Trust for stress echocardiography for investigation of ischaemic heart disease

Exclusion Criteria:

* More than moderate valvular heart disease
* Left ventricular outflow tract obstruction defined as a gradient \> 30mmHg (fixed or dynamic; supravalvular, valvular or sub-valvular)
* Significant co-morbidities (e.g. cancer) with an expected life-expectancy of under 12 months in the investigator's opinion
* Previous coronary artery bypass graft or other cardiac surgery
* Congenital or inherited myocardial disease

Primary outcomes:
measure: Investigate if EchoGo plus standard care is non-inferior to standard care alone for aiding referral to coronary angiogram following stress echocardiogram (SE)
timeFrame: 6 months post stress echo
Secondary outcomes:
measure: Investigate if EchoGo plus standard care is superior to standard care alone in predicting the risk of severe cardiovascular disease following stress echocardiogram (SE)
timeFrame: 6 month post stress echo
measure: Investigate the appropriate clinical management decisions made when using EchoGo plus standard care compared to standard care alone.
timeFrame: 6 month post stress echo
measure: Establish if clinical management decision making is affected by review of the EchoGo report.
timeFrame: 6 month
measure: Establish if using the EchoGo platform affects clinician diagnostic confidence.
timeFrame: 3 and 6 months post stress echo
measure: Establish if clinician diagnostic performance variance reduces with EchoGo use.
timeFrame: 3 and 6 month post stress echo
measure: Establish if using Ultromics' EchoGo Platform affects the number of subsequent investigations for cardiovascular disease. for cardiovascular disease
timeFrame: 3 and 6 months post stress echo
measure: Establish if using Ultromics' EchoGo Platform affects patient reported coronary artery disease symptoms.
timeFrame: 3 and 6 months post stress echo
measure: Assess the health economics impact of implementation and use of Ultromics' EchoGo platform in NHS units
timeFrame: 3 and 6 month post stress echo
Other outcomes:
Locations:
city: Swindon
country: United Kingdom
facility: Great Western Hospitals NHS Foundation Trust
state: Oxfordshire
city: Basildon
country: United Kingdom
facility: Mid and South Essex NHS Foundation Trust
city: Bath
country: United Kingdom
facility: Royal United Hospitals Bath
city: Birmingham
country: United Kingdom
facility: University Hospitals Birmingham NHS Foundation Trust
city: Blackpool
country: United Kingdom
facility: Blackpool Victoria Hospital
city: Coventry
country: United Kingdom
facility: University Hospitals Coventry & Warwickshire
city: Hexham
country: United Kingdom
facility: Northumbria Healthcare NHS Foundation Trust
city: High Wycombe
country: United Kingdom
facility: Buckinghamshire Healthcare NHS Trust
city: Ipswich
country: United Kingdom
facility: Ipswich General Hospital
city: Leicester
country: United Kingdom
facility: Leicester General Hospital
city: London
country: United Kingdom
facility: St George's University Hospitals NHS Foundation Trust
city: Milton Keynes
country: United Kingdom
facility: Milton Keynes University Hospital
city: Northampton
country: United Kingdom
facility: Northampton General Hospital NHS Trust
city: Oldham
country: United Kingdom
facility: Royal Oldham Hospital
city: Oxford
country: United Kingdom
facility: Oxford University Hospitals NHS Foundation Trust
city: Peterborough
country: United Kingdom
facility: North West Anglia NHS Foundation Trust
city: Reading
country: United Kingdom
facility: Royal Berkshire Hospital
city: Salford
country: United Kingdom
facility: Salford Royal Hospital
city: Stockport
country: United Kingdom
facility: Stockport NHS Foundation Trust
city: Wigan
country: United Kingdom
facility: Wrightington, Wigan and Leigh Teaching Hospitals NHS Foundation Trust
Study officials:
References: