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

Ultromics

Status: Active, not recruiting

Conditions: Coronary Heart Disease

Treatments: Diagnostic Test: EchoGo

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT05028179

COL-69

Details and patient eligibility

About

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.

Full 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.

Enrollment: 2,338 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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2,338 participants in 2 patient groups

Standard Care (comparator)

No Intervention group

Description:

Patients will receive standard care

Standard Care plus AI platform (EchoGo)

Experimental group

Description:

Patients will receive standard care plus their Echocardiogram will be sent to Ultromics for AI assessment. The report from the assessment will be sent to the clinician, and utilised to inform the patients further care.

Treatment:

Diagnostic Test: EchoGo