PROTEUS: Evaluating the Use of Artificial Intelligence to Support Stress Echocardiography Testing for Heart Disease
NCT ID: NCT05028179
Last Updated: 2023-11-30
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
NA
2338 participants
INTERVENTIONAL
2021-11-08
2023-12-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
* Standard care group (comparator)
* Standard care plus AI platform (EchoGo)
HEALTH_SERVICES_RESEARCH
SINGLE
In order to minimise bias in any outcome assessment clinicians will be asked not to share the details of the EchoGo report received for participants within the intervention arm with the participant or with colleagues who may undertake future investigations eg: angiography.If a clinician subsequently considers there is a clinical need to know the details of the EchoGo report this can be made available at the discretion of the study team.
Study Groups
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Standard Care (comparator)
Patients will receive standard care
No interventions assigned to this group
Standard Care plus AI platform (EchoGo)
Patients will receive standard care plus their Echocardiogram will be sent to Ultromics for AI assessment. The report from the assessment will be sent to the clinician, and utilised to inform the patients further care.
EchoGo
EchoGo Pro is an software Medical Device which is able to assess Stress Echocardiograms and provide a binary classification of risk of CAD
Interventions
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EchoGo
EchoGo Pro is an software Medical Device which is able to assess Stress Echocardiograms and provide a binary classification of risk of CAD
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
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University of Oxford
OTHER
Academic Health Science Centres
OTHER
National Institute for Health Research, United Kingdom
OTHER_GOV
Ultromics Ltd
INDUSTRY
Responsible Party
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Locations
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Great Western Hospitals NHS Foundation Trust
Swindon, Oxfordshire, United Kingdom
Mid and South Essex NHS Foundation Trust
Basildon, , United Kingdom
Royal United Hospitals Bath
Bath, , United Kingdom
University Hospitals Birmingham NHS Foundation Trust
Birmingham, , United Kingdom
Blackpool Victoria Hospital
Blackpool, , United Kingdom
University Hospitals Coventry & Warwickshire
Coventry, , United Kingdom
Northumbria Healthcare NHS Foundation Trust
Hexham, , United Kingdom
Buckinghamshire Healthcare NHS Trust
High Wycombe, , United Kingdom
Ipswich General Hospital
Ipswich, , United Kingdom
Leicester General Hospital
Leicester, , United Kingdom
St George's University Hospitals NHS Foundation Trust
London, , United Kingdom
Milton Keynes University Hospital
Milton Keynes, , United Kingdom
Northampton General Hospital NHS Trust
Northampton, , United Kingdom
Royal Oldham Hospital
Oldham, , United Kingdom
Oxford University Hospitals NHS Foundation Trust
Oxford, , United Kingdom
North West Anglia NHS Foundation Trust
Peterborough, , United Kingdom
Royal Berkshire Hospital
Reading, , United Kingdom
Salford Royal Hospital
Salford, , United Kingdom
Stockport NHS Foundation Trust
Stockport, , United Kingdom
Wrightington, Wigan and Leigh Teaching Hospitals NHS Foundation Trust
Wigan, , United Kingdom
Countries
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References
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Fazakarley CA, Breen M, Leeson P, Thompson B, Williamson V. Experiences of using artificial intelligence in healthcare: a qualitative study of UK clinician and key stakeholder perspectives. BMJ Open. 2023 Dec 11;13(12):e076950. doi: 10.1136/bmjopen-2023-076950.
Woodward G, Bajre M, Bhattacharyya S, Breen M, Chiocchia V, Dawes H, Dehbi HM, Descamps T, Frangou E, Fazakarley CA, Harris V, Hawkes W, Hewer O, Johnson CL, Krasner S, Laidlaw L, Lau J, Marwick T, Petersen SE, Piotrowska H, Ridgeway G, Ripley DP, Sanderson E, Savage N, Sarwar R, Tetlow L, Thompson B, Thulborn S, Williamson V, Woodward W, Upton R, Leeson P. PROTEUS Study: A Prospective Randomized Controlled Trial Evaluating the Use of Artificial Intelligence in Stress Echocardiography. Am Heart J. 2023 Sep;263:123-132. doi: 10.1016/j.ahj.2023.05.003. Epub 2023 May 14.
Other Identifiers
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COL-69
Identifier Type: -
Identifier Source: org_study_id