PROTEUS Study: A Prospective Randomized Controlled Trial Evaluating the Use of Artificial Intelligence in Stress Echocardiography

Gary Woodward; Mamta Bajre; Sanjeev Bhattacharyya; Maria Breen; Virginia Chiocchia; Helen Dawes; Hakim Moulay Dehbi; Tine Descamps; Elena Frangou; Carol Ann Fazakarley; Victoria Harris; Will Hawkes; Oliver Hewer; Casey L. Johnson; Samuel Krasner; Lynn Laidlaw; Jonathan Lau; Tom Marwick; Steffen E. Petersen; Hania Piotrowska; Ged Ridgeway; David P. Ripley; Emily Sanderson; Natalie Savage; Rizwan Sarwar; Louise Tetlow; Ben Thompson; Samantha Thulborn; Victoria Williamson; William Woodward; Ross Upton; Paul Leeson

doi:10.1016/j.ahj.2023.05.003

PROTEUS Study: A Prospective Randomized Controlled Trial Evaluating the Use of Artificial Intelligence in Stress Echocardiography

Gary Woodward, Mamta Bajre, Sanjeev Bhattacharyya, Maria Breen, Virginia Chiocchia, Helen Dawes, Hakim Moulay Dehbi, Tine Descamps, Elena Frangou, Carol Ann Fazakarley, Victoria Harris, Will Hawkes, Oliver Hewer, Casey L. Johnson, Samuel Krasner, Lynn Laidlaw, Jonathan Lau, Tom Marwick, Steffen E. Petersen, Hania PiotrowskaGed Ridgeway, David P. Ripley, Emily Sanderson, Natalie Savage, Rizwan Sarwar, Louise Tetlow, Ben Thompson, Samantha Thulborn, Victoria Williamson, William Woodward, Ross Upton, Paul Leeson

Department of Psychology

Research output: Contribution to journal › Article › peer-review

6 Citations (SciVal)

Abstract

Background: Stress echocardiography (SE) is one of the most commonly used diagnostic imaging tests for coronary artery disease (CAD) but requires clinicians to visually assess scans to identify patients who may benefit from invasive investigation and treatment. EchoGo Pro provides an automated interpretation of SE based on artificial intelligence (AI) image analysis. In reader studies, use of EchoGo Pro when making clinical decisions improves diagnostic accuracy and confidence. Prospective evaluation in real world practice is now important to understand the impact of EchoGo Pro on the patient pathway and outcome.

Methods: PROTEUS is a randomized, multicenter, 2-armed, noninferiority study aiming to recruit 2,500 participants from National Health Service (NHS) hospitals in the UK referred to SE clinics for investigation of suspected CAD. All participants will undergo a stress echocardiogram protocol as per local hospital policy. Participants will be randomized 1:1 to a control group, representing current practice, or an intervention group, in which clinicians will receive an AI image analysis report (EchoGo Pro, Ultromics Ltd, Oxford, UK) to use during image interpretation, indicating the likelihood of severe CAD. The primary outcome will be appropriateness of clinician decision to refer for coronary angiography. Secondary outcomes will assess other health impacts including appropriate use of other clinical management approaches, impact on variability in decision making, patient and clinician qualitative experience and a health economic analysis.

Discussion: This will be the first study to assess the impact of introducing an AI medical diagnostic aid into the standard care pathway of patients with suspected CAD being investigated with SE.

Trial Registration: Clinicaltrials.gov registration number NCT05028179, registered on 31 August 2021; ISRCTN: ISRCTN15113915; IRAS ref: 293515; REC ref: 21/NW/0199.

Original language	English
Pages (from-to)	123-132
Number of pages	10
Journal	American Heart Journal
Volume	263
Early online date	14 May 2023
DOIs	https://doi.org/10.1016/j.ahj.2023.05.003
Publication status	Published - 30 Sept 2023

Funding

This research was funded by the Artificial Intelligence in Health and Care Award, a competitive process run by the ACC in partnership with NHSx and the NIHR. The views expressed are those of the authors and not necessarily those of the NHSx, the NIHR or AAC. The funding body had oversight of the design of the protocol, but no involvement in the writing of this manuscript.

ASJC Scopus subject areas

Cardiology and Cardiovascular Medicine

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Woodward, G., Bajre, M., Bhattacharyya, S., Breen, M., Chiocchia, V., Dawes, H., Dehbi, H. M., Descamps, T., Frangou, E., Fazakarley, C. A., Harris, V., Hawkes, W., Hewer, O., Johnson, C. L., Krasner, S., Laidlaw, L., Lau, J., Marwick, T., Petersen, S. E., ... Leeson, P. (2023). PROTEUS Study: A Prospective Randomized Controlled Trial Evaluating the Use of Artificial Intelligence in Stress Echocardiography. American Heart Journal, 263, 123-132. https://doi.org/10.1016/j.ahj.2023.05.003

Woodward, G, Bajre, M, Bhattacharyya, S, Breen, M, Chiocchia, V, Dawes, H, Dehbi, HM, Descamps, T, Frangou, E, Fazakarley, CA, Harris, V, Hawkes, W, Hewer, O, Johnson, CL, Krasner, S, Laidlaw, L, Lau, J, Marwick, T, Petersen, SE, Piotrowska, H, Ridgeway, G, Ripley, DP, Sanderson, E, Savage, N, Sarwar, R, Tetlow, L, Thompson, B, Thulborn, S, Williamson, V, Woodward, W, Upton, R & Leeson, P 2023, 'PROTEUS Study: A Prospective Randomized Controlled Trial Evaluating the Use of Artificial Intelligence in Stress Echocardiography', American Heart Journal, vol. 263, pp. 123-132. https://doi.org/10.1016/j.ahj.2023.05.003

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title = "PROTEUS Study: A Prospective Randomized Controlled Trial Evaluating the Use of Artificial Intelligence in Stress Echocardiography",

abstract = "Background: Stress echocardiography (SE) is one of the most commonly used diagnostic imaging tests for coronary artery disease (CAD) but requires clinicians to visually assess scans to identify patients who may benefit from invasive investigation and treatment. EchoGo Pro provides an automated interpretation of SE based on artificial intelligence (AI) image analysis. In reader studies, use of EchoGo Pro when making clinical decisions improves diagnostic accuracy and confidence. Prospective evaluation in real world practice is now important to understand the impact of EchoGo Pro on the patient pathway and outcome. Methods: PROTEUS is a randomized, multicenter, 2-armed, noninferiority study aiming to recruit 2,500 participants from National Health Service (NHS) hospitals in the UK referred to SE clinics for investigation of suspected CAD. All participants will undergo a stress echocardiogram protocol as per local hospital policy. Participants will be randomized 1:1 to a control group, representing current practice, or an intervention group, in which clinicians will receive an AI image analysis report (EchoGo Pro, Ultromics Ltd, Oxford, UK) to use during image interpretation, indicating the likelihood of severe CAD. The primary outcome will be appropriateness of clinician decision to refer for coronary angiography. Secondary outcomes will assess other health impacts including appropriate use of other clinical management approaches, impact on variability in decision making, patient and clinician qualitative experience and a health economic analysis. Discussion: This will be the first study to assess the impact of introducing an AI medical diagnostic aid into the standard care pathway of patients with suspected CAD being investigated with SE. Trial Registration: Clinicaltrials.gov registration number NCT05028179, registered on 31 August 2021; ISRCTN: ISRCTN15113915; IRAS ref: 293515; REC ref: 21/NW/0199.",

author = "Gary Woodward and Mamta Bajre and Sanjeev Bhattacharyya and Maria Breen and Virginia Chiocchia and Helen Dawes and Dehbi, {Hakim Moulay} and Tine Descamps and Elena Frangou and Fazakarley, {Carol Ann} and Victoria Harris and Will Hawkes and Oliver Hewer and Johnson, {Casey L.} and Samuel Krasner and Lynn Laidlaw and Jonathan Lau and Tom Marwick and Petersen, {Steffen E.} and Hania Piotrowska and Ged Ridgeway and Ripley, {David P.} and Emily Sanderson and Natalie Savage and Rizwan Sarwar and Louise Tetlow and Ben Thompson and Samantha Thulborn and Victoria Williamson and William Woodward and Ross Upton and Paul Leeson",

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month = sep,

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doi = "10.1016/j.ahj.2023.05.003",

language = "English",

volume = "263",

pages = "123--132",

journal = "American Heart Journal",

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TY - JOUR

T1 - PROTEUS Study

T2 - A Prospective Randomized Controlled Trial Evaluating the Use of Artificial Intelligence in Stress Echocardiography

AU - Woodward, Gary

AU - Bajre, Mamta

AU - Bhattacharyya, Sanjeev

AU - Breen, Maria

AU - Chiocchia, Virginia

AU - Dawes, Helen

AU - Dehbi, Hakim Moulay

AU - Descamps, Tine

AU - Frangou, Elena

AU - Fazakarley, Carol Ann

AU - Harris, Victoria

AU - Hawkes, Will

AU - Hewer, Oliver

AU - Johnson, Casey L.

AU - Krasner, Samuel

AU - Laidlaw, Lynn

AU - Lau, Jonathan

AU - Marwick, Tom

AU - Petersen, Steffen E.

AU - Piotrowska, Hania

AU - Ridgeway, Ged

AU - Ripley, David P.

AU - Sanderson, Emily

AU - Savage, Natalie

AU - Sarwar, Rizwan

AU - Tetlow, Louise

AU - Thompson, Ben

AU - Thulborn, Samantha

AU - Williamson, Victoria

AU - Woodward, William

AU - Upton, Ross

AU - Leeson, Paul

PY - 2023/9/30

Y1 - 2023/9/30

N2 - Background: Stress echocardiography (SE) is one of the most commonly used diagnostic imaging tests for coronary artery disease (CAD) but requires clinicians to visually assess scans to identify patients who may benefit from invasive investigation and treatment. EchoGo Pro provides an automated interpretation of SE based on artificial intelligence (AI) image analysis. In reader studies, use of EchoGo Pro when making clinical decisions improves diagnostic accuracy and confidence. Prospective evaluation in real world practice is now important to understand the impact of EchoGo Pro on the patient pathway and outcome. Methods: PROTEUS is a randomized, multicenter, 2-armed, noninferiority study aiming to recruit 2,500 participants from National Health Service (NHS) hospitals in the UK referred to SE clinics for investigation of suspected CAD. All participants will undergo a stress echocardiogram protocol as per local hospital policy. Participants will be randomized 1:1 to a control group, representing current practice, or an intervention group, in which clinicians will receive an AI image analysis report (EchoGo Pro, Ultromics Ltd, Oxford, UK) to use during image interpretation, indicating the likelihood of severe CAD. The primary outcome will be appropriateness of clinician decision to refer for coronary angiography. Secondary outcomes will assess other health impacts including appropriate use of other clinical management approaches, impact on variability in decision making, patient and clinician qualitative experience and a health economic analysis. Discussion: This will be the first study to assess the impact of introducing an AI medical diagnostic aid into the standard care pathway of patients with suspected CAD being investigated with SE. Trial Registration: Clinicaltrials.gov registration number NCT05028179, registered on 31 August 2021; ISRCTN: ISRCTN15113915; IRAS ref: 293515; REC ref: 21/NW/0199.

AB - Background: Stress echocardiography (SE) is one of the most commonly used diagnostic imaging tests for coronary artery disease (CAD) but requires clinicians to visually assess scans to identify patients who may benefit from invasive investigation and treatment. EchoGo Pro provides an automated interpretation of SE based on artificial intelligence (AI) image analysis. In reader studies, use of EchoGo Pro when making clinical decisions improves diagnostic accuracy and confidence. Prospective evaluation in real world practice is now important to understand the impact of EchoGo Pro on the patient pathway and outcome. Methods: PROTEUS is a randomized, multicenter, 2-armed, noninferiority study aiming to recruit 2,500 participants from National Health Service (NHS) hospitals in the UK referred to SE clinics for investigation of suspected CAD. All participants will undergo a stress echocardiogram protocol as per local hospital policy. Participants will be randomized 1:1 to a control group, representing current practice, or an intervention group, in which clinicians will receive an AI image analysis report (EchoGo Pro, Ultromics Ltd, Oxford, UK) to use during image interpretation, indicating the likelihood of severe CAD. The primary outcome will be appropriateness of clinician decision to refer for coronary angiography. Secondary outcomes will assess other health impacts including appropriate use of other clinical management approaches, impact on variability in decision making, patient and clinician qualitative experience and a health economic analysis. Discussion: This will be the first study to assess the impact of introducing an AI medical diagnostic aid into the standard care pathway of patients with suspected CAD being investigated with SE. Trial Registration: Clinicaltrials.gov registration number NCT05028179, registered on 31 August 2021; ISRCTN: ISRCTN15113915; IRAS ref: 293515; REC ref: 21/NW/0199.

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DO - 10.1016/j.ahj.2023.05.003

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SN - 0002-8703

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JO - American Heart Journal

JF - American Heart Journal

ER -

PROTEUS Study: A Prospective Randomized Controlled Trial Evaluating the Use of Artificial Intelligence in Stress Echocardiography

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