Coronary Heart Disease
Conditions
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.
Interventions
DIAGNOSTIC_TESTEchoGo
EchoGo Pro is an software Medical Device which is able to assess Stress Echocardiograms and provide a binary classification of risk of CAD
Sponsors
University of Oxford
Academic Health Science Centres
National Institute for Health Research, United Kingdom
Ultromics Ltd
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
SINGLE (Subject)
Masking description
Following the stress echocardiogram examination, participants will follow the care pathway determined by the clinical team managing their care. If the participant is assigned to the study intervention arm the EchoGo report will inform this decision making process. 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.
Intervention model description
A multi-centre, two-arm, randomised controlled trial. Randomised 1:1 * Standard care group (comparator) * Standard care plus AI platform (EchoGo)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| Investigate 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 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. |
| 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. |
| 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 months |
| 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 |
| 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 |
| 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. |
Countries
United Kingdom
Outcome results
None listed