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.

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.

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

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.