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

作者：Gary Woodward, Mamta Bajre, Sanjeev Bhattacharyya, Maria Breen, Virginia Chiocchia, Helen Dawes, Hakim‐Moulay Dehbi, Tine Descamps, Eleni 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 Ann Tetlow, Benjamin Thompson, Samantha Thulborn, Victoria Williamson, William Woodward, Ross Upton, Paul Leeson · 发表于：American Heart Journal · 年份：2023 · DOI：10.1016/j.ahj.2023.05.003 · 被引用次数：25 · 研究领域：Cardiac Imaging and Diagnostics、Artificial Intelligence in Healthcare and Education、Cardiovascular Function and Risk Factors

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, patie...