Ask to take part

Contact the study team using the details below to take part. If there are no contact details below please ask your doctor in the first instance.

Contact Information:

Dr Gary Woodward
+44 (0)7515 998737
Proteus@ultromics.com


Dr Ben Thompson
+44 (0)7515 998737
Proteus@ultromics.com


More information about this study, what is involved and how to take part can be found on the study website.

Study Location:

Cardiac Clinical Research Facility (Oxford University)
Cardiovascular Clinical Research Facility Level 1 Oxford Heart Centre John Radcliffe Hospital Headley Way Headington
Oxford
OX3 9DU


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PROTEUS: Evaluating the use of artificial intelligence to support stress echocardiography testing for heart disease

Recruiting

Open to: All Genders

Age: Adult

Medical Conditions

AI assessment of patients with suspected Coronary Artery Disease (CAD)


This information is provided directly by researchers and we recognise that it isn't always easy to understand. We are working with researchers to improve the accessibility of this information.




Background and study aims
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.

Who can participate?
Adult patients who have been referred for a stress echocardiogram for the assessment of CAD.

What does the study involve?
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.

What are the possible benefits and risks of participating?
There are no direct benefits or risks. The data collected in this study could benefit future patients if:
EchoGo could help future patients receive the best possible care,
If EchoGo could save the health service money,
If clinicians are confident in the EchoGo reports,
If EchoGo reduces the numbers of patients undergoing serious cardiac events,
If EchoGo reduces the variation normally seen in Stress Echocardiography.

Where is the study run from?
Ultromics Ltd (Oxford)

When is the study starting and how long is it expected to run for?
July 2021 to December 2023

Who is funding the study?
National Institute for Health Research (NIHR) (UK).

Null hypothesis: The intervention (EchoGo plus standard care) is inferior to the comparator (standard care), with the difference in AUROC between comparator and intervention greater or equal to the non-inferiority margin of 0.05 (C-I ≥ 0.05)


Multicentre two arm randomized controlled trial

Start dates may differ between countries and research sites. The research team are responsible for keeping the information up-to-date.  

The recruitment start and end dates are as follows:

08 Nov 2021

30 Jun 2023

Interventional

Intervention Type : Device
Intervention Description : Eligible patients will be randomised using a secure online randomisation tool. Participants will be randomised 1:1 to receive 1) standard care (comparator) or 2) AI supported standard care (intervention). Participants in both arms will have a stress echocardiographic (SE) examination undertaken according to local trust practice. For the intervention group, images taken during the SE exam will be securely transferred to Ultromics and analysed by the EchoGo Pro AI tool. The AI software will generate a report containing a binary classification of the risk of cardiovascular disease for the patient. The EchoGo Pro report will be returned to the treating clinician in real time. The clinician may use the report to inform their treatment plan for the participant at their discretion. Participants will be follow-up for 6 months following the SE. Notes reviews will be conducted at 3 and 6 months. Patient reported health economic and symptom outcome data will be collected at 3 and 6 months.


You can take part if:


1. Willing and able to provide informed consent2. Male or female, ≥18 years of age at study entry3. Referred to an NHS Trust for stress echocardiography for investigation of ischaemic heart disease




You may not be able to take part if:

1. More than moderate valvular heart disease2. Left ventricular outflow tract obstruction defined as a gradient > 30mmHg (fixed or dynamic; supravalvular, valvular or sub-valvular)3. Significant co-morbidities (e.g. cancer) with an expected life-expectancy of under 12 months in the investigator's opinion4. Previous coronary artery bypass graft or other cardiac surgery5. Congenital or inherited myocardial disease


Below are the locations for where you can take part in the trial. Please note that not all sites may be open.

  • Cardiac Clinical Research Facility (Oxford University)
    Cardiovascular Clinical Research Facility Level 1 Oxford Heart Centre John Radcliffe Hospital Headley Way Headington
    Oxford
    OX3 9DU

Dr Ben Thompson
+44 (0)7515 998737
Proteus@ultromics.com


Dr Gary Woodward
+44 (0)7515 998737
Proteus@ultromics.com


More information about this study, what is involved and how to take part can be found on the study website.


The study is sponsored by Ultromics Ltd and funded by National Institute for Health Research.



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for Trial ID: ISRCTN15113915

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