NCT05028179

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

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

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 2,338 (actual)
• Sponsor: Ultromics Ltd · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Coronary Heart Disease

Interventions

Type	Name	Description
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

Timeline

• Start date: 2021-11-08
• Primary completion: 2023-06-30
• Completion: 2023-12-31
• First posted: 2021-08-31
• Last updated: 2023-11-30

Locations

20 sites across 1 country: United Kingdom