PROTEUS: Evaluating the Use of Artificial Intelligence to Support Stress Echocardiography Testing for Heart Disease

Ultromics Ltd2,338 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

HEALTH_SERVICES_RESEARCH

Masking

SINGLE

Enrollment

2,338

Conditions

Coronary Heart Disease

Interventions

EchoGoDIAGNOSTIC_TEST

EchoGo Pro is an software Medical Device which is able to assess Stress Echocardiograms and provide a binary classification of risk of CAD

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (20)

Great Western Hospitals NHS Foundation Trust

Swindon, Oxfordshire, United Kingdom

Mid and South Essex NHS Foundation Trust

Outcomes

Primary Outcomes

Investigate if EchoGo plus standard care is non-inferior to standard care alone for aiding referral to coronary angiogram following stress echocardiogram (SE)

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.

Time frame: 6 months post stress echo

Secondary Outcomes

Investigate if EchoGo plus standard care is superior to standard care alone in predicting the risk of severe cardiovascular disease following stress echocardiogram (SE)

Outcome shall be measured through - AUROC for the ability to make an appropriate referral to coronary angiogram.

Time frame: 6 month post stress echo

Investigate the appropriate clinical management decisions made when using EchoGo plus standard care compared to standard care alone.

Outcome measure - Appropriate clinical management following an echocardiogram, for referring a patient to coronary angiogram, determined by adjudication committee review of follow up data.

Time frame: 6 month post stress echo

Establish if clinical management decision making is affected by review of the EchoGo report.

Establish if clinical management decision making is affected by review of the EchoGo report as recorded by clinician self-report.

Time frame: 6 month

Establish if using the EchoGo platform affects clinician diagnostic confidence.

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.

Data from ClinicalTrials.gov

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