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

Coronary Heart Disease Clinical Trial

— PROTEUS  

Official title:

PROTEUS: A PROspective Randomised Controlled Trial Evaluating the Use of Artificial Intelligence in Stress Echocardiology

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05028179
• Other study ID #: COL-69
• Status: Active, not recruiting
• Phase: N/A
• Start date: November 8, 2021
• Est. completion date: December 31, 2023

Study information

• Verified date: November 2023
• Source: Ultromics Ltd
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Active, not recruiting
• Enrollment: 2338
• Est. completion date: December 31, 2023
• Est. primary completion date: June 30, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Coronary Artery Disease
• Coronary Disease
• Coronary Heart Disease
• Heart Diseases
• Myocardial Ischemia

Intervention

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

Locations

Country	Name	City	State
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	Great Western Hospitals NHS Foundation Trust	Swindon	Oxfordshire
United Kingdom	Wrightington, Wigan and Leigh Teaching Hospitals NHS Foundation Trust	Wigan

Sponsors (4)

Lead Sponsor	Collaborator
Ultromics Ltd	Academic Health Science Centres, National Institute for Health Research, United Kingdom, University of Oxford

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	6 months post stress echo
Secondary	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.	6 month post stress echo
Secondary	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.	6 month post stress echo
Secondary	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.	6 month
Secondary	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.	3 and 6 months post stress echo
Secondary	Establish if clinician diagnostic performance variance reduces with EchoGo use.	Outcome measured by Inter-clinician and in-site variability at baseline, 3 months and at end of study.	3 and 6 month post stress echo
Secondary	Establish if using Ultromics' EchoGo Platform affects the number of subsequent investigations for cardiovascular disease. for cardiovascular disease	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	3 and 6 months post stress echo
Secondary	Establish if using Ultromics' EchoGo Platform affects patient reported coronary artery disease symptoms.	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	3 and 6 months post stress echo
Secondary	Assess the health economics impact of implementation and use of Ultromics' EchoGo platform in NHS units	Outcome measure - Patient reported health related quality of life	3 and 6 month post stress echo