PROTEUS: Evaluating the Use of Artificial Intelligence to Support Stress Echocardiography Testing for Heart Disease
- Conditions
- Coronary Heart Disease
- Registration Number
- NCT05028179
- Lead Sponsor
- Ultromics Ltd
- 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.
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 2338
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Investigate if EchoGo plus standard care is non-inferior to standard care alone for aiding referral to coronary angiogram following stress echocardiogram (SE) 6 months post stress echo Outcome measure - AUROC for the ability to make an appropriate referral to coronary angiogram at 6 months following stress echocardiogram.
Appropriate management will be defined as a composite of
* coronary angiography that demonstrates severe coronary disease fulfilling clinical care guidelines for revascularisation or
* decision for medical management/reassurance without unanticipated serious adverse cardiac events Outcome data will be collected from participant's medical records at 3 and 6 months.
- Secondary Outcome Measures
Name Time Method Establish if clinical management decision making is affected by review of the EchoGo report. 6 month Establish if clinical management decision making is affected by review of the EchoGo report as recorded by clinician self-report.
Establish if using the EchoGo platform affects clinician diagnostic confidence. 3 and 6 months post stress echo Clinician diagnostic confidence in their interpretation of the stress echo report will be measured by clinician self-report at baseline, 3 months and end of study at each participating site.
Establish if clinician diagnostic performance variance reduces with EchoGo use. 3 and 6 month post stress echo Outcome measured by Inter-clinician and in-site variability at baseline, 3 months and at end of study.
Establish if using Ultromics' EchoGo Platform affects the number of subsequent investigations for cardiovascular disease. for cardiovascular disease 3 and 6 months post stress echo Outcome shall be measured through collation of the number of incidences of the following (occurring up to 6 months following stress echo):
* Myocardial Perfusion Scan
* CT coronary angiogram
* Stress echo
* Invasive coronary angiogram
* Stress CMR
* Exercise tolerance test
* Initiation of anti-anginal medication/medical management of angina
Data will be collected from participants medical records at 3 and 6 monthsInvestigate the appropriate clinical management decisions made when using EchoGo plus standard care compared to standard care alone. 6 month post stress echo Outcome measure - Appropriate clinical management following an echocardiogram, for referring a patient to coronary angiogram, determined by adjudication committee review of follow up data.
Establish if using Ultromics' EchoGo Platform affects patient reported coronary artery disease symptoms. 3 and 6 months post stress echo Outcome shall be measured through the collation of the number of coronary artery disease symptoms and impact on participant health status as measured by patient-reported short Seattle Angina Questionnaire (SAQ-7) at trial entry, 3 months and 6 months
Investigate if EchoGo plus standard care is superior to standard care alone in predicting the risk of severe cardiovascular disease following stress echocardiogram (SE) 6 month post stress echo Outcome shall be measured through - AUROC for the ability to make an appropriate referral to coronary angiogram.
Assess the health economics impact of implementation and use of Ultromics' EchoGo platform in NHS units 3 and 6 month post stress echo Outcome measure - Patient reported health related quality of life
Trial Locations
- Locations (20)
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
Scroll for more (10 remaining)Great Western Hospitals NHS Foundation Trust🇬🇧Swindon, Oxfordshire, United Kingdom