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

NCT05028179 | Unknown DMC

• 1 other identifier: COL-69
• Study Type: interventional
• Target: 2,338
• Locations: 1 country
• Sites: 20

Brief 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.

Conditions

Coronary Heart Disease

Outcome Measures

Primary Outcomes (1)

• Investigate if EchoGo plus standard care is non-inferior to standard care alone for aiding referral to coronary angiogram following stress echocardiogram (SE)

  Outcome measure - AUROC for the ability to make an appropriate referral to coronary angiogram at 6 months following stress echocardiogram. Appropriate management will be defined as a composite of * coronary angiography that demonstrates severe coronary disease fulfilling clinical care guidelines for revascularisation or * decision for medical management/reassurance without unanticipated serious adverse cardiac events Outcome data will be collected from participant's medical records at 3 and 6 months.

  6 months post stress echo

Secondary Outcomes (8)

• Investigate if EchoGo plus standard care is superior to standard care alone in predicting the risk of severe cardiovascular disease following stress echocardiogram (SE)

  6 month post stress echo

• Investigate the appropriate clinical management decisions made when using EchoGo plus standard care compared to standard care alone.

  6 month post stress echo

• Establish if clinical management decision making is affected by review of the EchoGo report.

  6 month

• Establish if using the EchoGo platform affects clinician diagnostic confidence.

  3 and 6 months post stress echo

• Establish if clinician diagnostic performance variance reduces with EchoGo use.

  3 and 6 month post stress echo

Study Arms (2)

Standard Care (comparator)

NO INTERVENTION

Patients will receive standard care

Standard Care plus AI platform (EchoGo)

EXPERIMENTAL

Patients will receive standard care plus their Echocardiogram will be sent to Ultromics for AI assessment. The report from the assessment will be sent to the clinician, and utilised to inform the patients further care.

Diagnostic Test: EchoGo

Interventions

EchoGo DIAGNOSTIC_TEST

EchoGo Pro is an software Medical Device which is able to assess Stress Echocardiograms and provide a binary classification of risk of CAD

Standard Care plus AI platform (EchoGo)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Ultromics Ltd: lead
• University of Oxford: collaborator
• Academic Health Science Centres: collaborator
• National Institute for Health Research, United Kingdom: collaborator

Study Sites (20)

Great Western Hospitals NHS Foundation Trust

Swindon, Oxfordshire, United Kingdom

Location

Mid and South Essex NHS Foundation Trust

Basildon, United Kingdom

Location

Royal United Hospitals Bath

Bath, United Kingdom

Location

University Hospitals Birmingham NHS Foundation Trust

Birmingham, United Kingdom

Location

Blackpool Victoria Hospital

Blackpool, United Kingdom

Location

University Hospitals Coventry & Warwickshire

Coventry, United Kingdom

Location

Northumbria Healthcare NHS Foundation Trust

Hexham, United Kingdom

Location

Buckinghamshire Healthcare NHS Trust

High Wycombe, United Kingdom

Location

Ipswich General Hospital

Ipswich, United Kingdom

Location

Leicester General Hospital

Leicester, United Kingdom

Location

St George's University Hospitals NHS Foundation Trust

London, United Kingdom

Location

Milton Keynes University Hospital

Milton Keynes, United Kingdom

Location

Northampton General Hospital NHS Trust

Northampton, United Kingdom

Location

Royal Oldham Hospital

Oldham, United Kingdom

Location

Oxford University Hospitals NHS Foundation Trust

Oxford, United Kingdom

Location

North West Anglia NHS Foundation Trust

Peterborough, United Kingdom

Location

Royal Berkshire Hospital

Reading, United Kingdom

Location

Salford Royal Hospital

Salford, United Kingdom

Location

Stockport NHS Foundation Trust

Stockport, United Kingdom

Location

Wrightington, Wigan and Leigh Teaching Hospitals NHS Foundation Trust

Wigan, United Kingdom

Location

Related Publications (2)

• Fazakarley CA, Breen M, Leeson P, Thompson B, Williamson V. Experiences of using artificial intelligence in healthcare: a qualitative study of UK clinician and key stakeholder perspectives. BMJ Open. 2023 Dec 11;13(12):e076950. doi: 10.1136/bmjopen-2023-076950.

  PMID: 38081671 DERIVED

• 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. PROTEUS Study: A Prospective Randomized Controlled Trial Evaluating the Use of Artificial Intelligence in Stress Echocardiography. Am Heart J. 2023 Sep;263:123-132. doi: 10.1016/j.ahj.2023.05.003. Epub 2023 May 14.

  PMID: 37192698 DERIVED

MeSH Terms

Conditions

Coronary Disease

Condition Hierarchy (Ancestors)

Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Following the stress echocardiogram examination, participants will follow the care pathway determined by the clinical team managing their care. If the participant is assigned to the study intervention arm the EchoGo report will inform this decision making process. In order to minimise bias in any outcome assessment clinicians will be asked not to share the details of the EchoGo report received for participants within the intervention arm with the participant or with colleagues who may undertake future investigations eg: angiography.If a clinician subsequently considers there is a clinical need to know the details of the EchoGo report this can be made available at the discretion of the study team.
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: A multi-centre, two-arm, randomised controlled trial. Randomised 1:1 * Standard care group (comparator) * Standard care plus AI platform (EchoGo)

Study Record Dates

• First Submitted: July 22, 2021
• First Posted: August 31, 2021
• Study Start: November 8, 2021
• Primary Completion: June 30, 2023
• Study Completion: December 31, 2023
• Last Updated: November 30, 2023

Record last verified: 2023-11

Locations

GB (20)