PROTEUS: Evaluating the Use of AI in Stress Echocardiography

• Research type

  Research Study

• Full title

  PROTEUS: A Prospective randomised controlled Trial Evaluating the Use of AI in Stress Echocardiography

• IRAS ID

  293515

• Contact name

  Gary Woodward

• Contact email

  gary.woodward@ultromics.com

• Sponsor organisation

  Ultromics Ltf

• Clinicaltrials.gov Identifier

  NCT05028179

• Duration of Study in the UK

  1 years, 7 months, 31 days

• Research summary

  Coronary Artery Disease (CAD) is a leading cause of death in the UK. Stress echocardiography (SE) remains the only imaging method available widely in the UK to diagnose CAD, however its accuracy varies for a number of reasons – for example image quality and the expertise of the clinician assessing it.

  A reliable, automated method to analyse scans is therefore required to reduce variability and improve the accuracy of diagnosis. Ultromics (a spin out company from the University of Oxford), has developed software called EchoGo. EchoGo processes echocardiographic images using Artificial Intelligence (AI), aiming to aid CAD diagnosis by taking more detailed measurements. The AI model was developed by processing images from patients who previously underwent SE exam. Analysis of its performance shows higher accuracy than clinical practice.

  Having tested EchoGo performance on retrospective echocardiogram images, it now requires testing in clinical practice. We propose a prospective Randomised Controlled Trial evaluating the use of EchoGo to aid clinical decision making.

  The trial will recruit 2500 adults referred for SE examination in up to 20 NHS units in the UK. Participants will be randomised (1:1) to receive either:
  - Standard care
  - Standard care with EchoGo report

  Participants will be followed-up at 3 months and 6 months after SE scan, via medical notes review and a short quality of life and symptom questionnaire. The trial will assess if using EchoGo improves patients’ clinical outcomes and improves accuracy of diagnosis.

  A health economic analysis will also be conducted and a qualitative sub-study will investigate attitudes of NHS stakeholders to the adoption of AI within the NHS.

• REC name

  North West - Preston Research Ethics Committee

• REC reference

  21/NW/0199

• Date of REC Opinion

  15 Jul 2021

• REC opinion

  Further Information Favourable Opinion