Coronary Heart DiseasePROTEUSNCT05028179
PROTEUS: Evaluating the Use of Artificial Intelligence to Support Stress Echocardiography Testing for Heart Disease
A study testing EchoGo in people with Coronary Heart Disease, run by Ultromics Ltd at 20 sites in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Coronary Heart Disease
- What is being tested?
- EchoGo
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2,338 participants
- Where
- 20 sitesUnited Kingdom
- Study dates
- 8 Nov 2021to 31 Dec 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
20 sites in 1 country.
20 sites in 1 country
United Kingdom20 sites
Mid and South Essex NHS Foundation Trust
Basildon
Royal United Hospitals Bath
Bath
University Hospitals Birmingham NHS Foundation Trust
Birmingham
Blackpool Victoria Hospital
Blackpool
University Hospitals Coventry & Warwickshire
Coventry
Northumbria Healthcare NHS Foundation Trust
Hexham
Buckinghamshire Healthcare NHS Trust
High Wycombe
Ipswich General Hospital
Ipswich
Leicester General Hospital
Leicester
St George's University Hospitals NHS Foundation Trust
London
Milton Keynes University Hospital
Milton Keynes
Northampton General Hospital NHS Trust
Northampton
Royal Oldham Hospital
Oldham
Oxford University Hospitals NHS Foundation Trust
Oxford
North West Anglia NHS Foundation Trust
Peterborough
Royal Berkshire Hospital
Reading
Salford Royal Hospital
Salford
Stockport NHS Foundation Trust
Stockport
Great Western Hospitals NHS Foundation Trust
Swindon, Oxfordshire
Wrightington, Wigan and Leigh Teaching Hospitals NHS Foundation Trust
Wigan
About this study
Official title: PROTEUS: A PROspective Randomised Controlled Trial Evaluating the Use of Artificial Intelligence in Stress Echocardiology
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.
Read the detailed description
Title: A Prospective Randomised Controlled Trial Evaluating the Use of AI in Stress Echocardiography
Trial design: Multi-centre, two-arm, Randomised Controlled Trial of a medical device. Randomised 1:1 to either:
- Standard care (comparator), or
- Standard care plus AI Platform (EchoGo) Trial participants: Adults undergoing clinically indicated stress echocardiogram (SE) to assess inducible ischaemia at participating NHS Trusts.
Having benchmarked the device performance (Upton 2019), and having successfully deployed and tested the required infrastructure, we now propose to prospectively test the software in clinical practice. Based on the existing data for accuracy we would expect use of the EchoGo Platform in the clinical pathway will have a significant benefit reducing inter-reader variability, increasing accuracy and thereby reducing health costs. To formally evaluate the impact of automated AI quantification and accuracy of the decision to make a referral to coronary angiogram, following stress echocardiography, we propose a prospective, multi-centre, randomised controlled trial that compares provision of an AI derived report to a clinician against clinician-only standard of care. This will provide the highest level of evidence of any potential benefit or disadvantages prior to adoption of the software for widespread clinical implementation.
- Conditions
- Coronary Heart Disease
- Being tested
- EchoGo
- Medical subject headings
- Coronary Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EchoGoDiagnostic test
EchoGo Pro is an software Medical Device which is able to assess Stress Echocardiograms and provide a binary classification of risk of CAD
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Diagnostic Test: EchoGo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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)
Outcome shall be measured through - AUROC for the ability to make an appropriate referral to coronary angiogram.
Measured: 6 month post stress echo
Investigate the appropriate clinical management decisions made when using EchoGo plus standard care compared to standard care alone.
Outcome measure - Appropriate clinical management following an echocardiogram, for referring a patient to coronary angiogram, determined by adjudication committee review of follow up data.
Measured: 6 month post stress echo
Establish if clinical management decision making is affected by review of the EchoGo report.
Establish if clinical management decision making is affected by review of the EchoGo report as recorded by clinician self-report.
Measured: 6 month
Establish if using the EchoGo platform affects clinician diagnostic confidence.
Clinician diagnostic confidence in their interpretation of the stress echo report will be measured by clinician self-report at baseline, 3 months and end of study at each participating site.
Measured: 3 and 6 months post stress echo
Establish if clinician diagnostic performance variance reduces with EchoGo use.
Outcome measured by Inter-clinician and in-site variability at baseline, 3 months and at end of study.
Measured: 3 and 6 month post stress echo
Establish if using Ultromics' EchoGo Platform affects the number of subsequent investigations for cardiovascular disease. for cardiovascular disease
Outcome shall be measured through collation of the number of incidences of the following (occurring up to 6 months following stress echo):
- Myocardial Perfusion Scan
- CT coronary angiogram
- Stress echo
- Invasive coronary angiogram
- Stress CMR
- Exercise tolerance test
- Initiation of anti-anginal medication/medical management of angina
Data will be collected from participants medical records at 3 and 6 months
Measured: 3 and 6 months post stress echo
Establish if using Ultromics' EchoGo Platform affects patient reported coronary artery disease symptoms.
Outcome shall be measured through the collation of the number of coronary artery disease symptoms and impact on participant health status as measured by patient-reported short Seattle Angina Questionnaire (SAQ-7) at trial entry, 3 months and 6 months
Measured: 3 and 6 months post stress echo
Assess the health economics impact of implementation and use of Ultromics' EchoGo platform in NHS units
Outcome measure - Patient reported health related quality of life
Measured: 3 and 6 month post stress echo
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Aug 2021
- Study start8 Nov 2021
- Primary completion30 Jun 2023
- Study completion31 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Coronary Heart DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- A multi-centre, two-arm, randomised controlled trial. Randomised 1:1 * Standard care group (comparator) * Standard care plus AI platform (EchoGo)
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 2,338 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ultromics Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- University of Oxford, Academic Health Science Centres, National Institute for Health Research, United Kingdom
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05028179
- Sponsor's protocol ID
- COL-69
- Acronym
- PROTEUS
- Status last verified
- Nov 2023
- First submitted
- 22 Jul 2021
- Last updated
- 30 Nov 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Upton R, Akerman AP, Marwick TH, Johnson CL, Piotrowska H, Bajre M, Breen M, Dawes H, Dehbi HM, Descamps T, Harris V, Hawkes W, Krasner S, Sanderson E, Savage N, Thompson B, Williamson V, Woodward W, Sarwar R, O'Driscoll J, Sharma R, Chiocchia V, Petersen SE, Frangou E, Ridgway G, Bhattacharyya S, Ripley DP, Woodward G, Leeson P. PROTEUS: A Prospective RCT Evaluating Use of AI in Stress Echocardiography. NEJM AI. 2024 Nov;1(11):AIoa2400865. doi: 10.1056/AIoa2400865. Epub 2024 Oct 18.
PubMed 42932762Fazakarley 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.
PubMed 38081671Woodward 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.
PubMed 37192698
Study at a glance
From the registry record, last updated by the sponsor on 30 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- PROTEUS: A PROspective Randomised Controlled Trial Evaluating the Use of Artificial Intelligence in Stress Echocardiology
- ClinicalTrials.gov ID
- NCT05028179
- Acronym / sponsor ID
- PROTEUS / COL-69
- Conditions
- Coronary Heart Disease
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 2,338 participants (actual)
- Lead sponsor
- Ultromics LtdIndustry (pharma, biotech, devices)
- Collaborators
- University of Oxford, Academic Health Science Centres, National Institute for Health Research, United Kingdom
- Study start
- 8 Nov 2021 (actual)
- Primary completion
- 30 Jun 2023 (actual)
- Study completion
- 31 Dec 2023 (estimated)
- First posted
- 31 Aug 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Title: A Prospective Randomised Controlled Trial Evaluating the Use of AI in Stress Echocardiography
Trial design: Multi-centre, two-arm, Randomised Controlled Trial of a medical device. Randomised 1:1 to either:
- Standard care (comparator), or
- Standard care plus AI Platform (EchoGo) Trial participants: Adults undergoing clinically indicated stress echocardiogram (SE) to assess inducible ischaemia at participating NHS Trusts.
Having benchmarked the device performance (Upton 2019), and having successfully deployed and tested the required infrastructure, we now propose to prospectively test the software in clinical practice. Based on the existing data for accuracy we would expect use of the EchoGo Platform in the clinical pathway will have a significant benefit reducing inter-reader variability, increasing accuracy and thereby reducing health costs. To formally evaluate the impact of automated AI quantification and accuracy of the decision to make a referral to coronary angiogram, following stress echocardiography, we propose a prospective, multi-centre, randomised controlled trial that compares provision of an AI derived report to a clinician against clinician-only standard of care. This will provide the highest level of evidence of any potential benefit or disadvantages prior to adoption of the software for widespread clinical implementation.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- A multi-centre, two-arm, randomised controlled trial. Randomised 1:1 * Standard care group (comparator) * Standard care plus AI platform (EchoGo)
| Arm | Type | Receives |
|---|---|---|
| Standard Care (comparator) | No intervention | –Patients will receive standard care |
| Standard Care plus AI platform (EchoGo) | Experimental | Diagnostic Test: EchoGoPatients 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| EchoGoEchoGo Pro is an software Medical Device which is able to assess Stress Echocardiograms and provide a binary classification of risk of CAD | Diagnostic test | Standard Care plus AI platform (EchoGo) |
Primary outcome
Investigate if EchoGo plus standard care is non-inferior to standard care alone for aiding referral to coronary angiogram following stress echocardiogram (SE)
Time frame: 6 months post stress echo
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.
8 secondary outcomes
Investigate if EchoGo plus standard care is superior to standard care alone in predicting the risk of severe cardiovascular disease following stress echocardiogram (SE)
Time frame: 6 month post stress echo
Investigate the appropriate clinical management decisions made when using EchoGo plus standard care compared to standard care alone.
Time frame: 6 month post stress echo
Establish if clinical management decision making is affected by review of the EchoGo report.
Time frame: 6 month
Establish if using the EchoGo platform affects clinician diagnostic confidence.
Time frame: 3 and 6 months post stress echo
Establish if clinician diagnostic performance variance reduces with EchoGo use.
Time frame: 3 and 6 month post stress echo
Establish if using Ultromics' EchoGo Platform affects the number of subsequent investigations for cardiovascular disease. for cardiovascular disease
Time frame: 3 and 6 months post stress echo
Establish if using Ultromics' EchoGo Platform affects patient reported coronary artery disease symptoms.
Time frame: 3 and 6 months post stress echo
Assess the health economics impact of implementation and use of Ultromics' EchoGo platform in NHS units
Time frame: 3 and 6 month post stress echo
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Nov 2023.
- Derived from this study: PubMed 42932762Upton R, Akerman AP, Marwick TH, Johnson CL, Piotrowska H, Bajre M, Breen M, Dawes H, Dehbi HM, Descamps T, Harris V, Hawkes W, Krasner S, Sanderson E, Savage N, Thompson B, Williamson V, Woodward W, Sarwar R, O'Driscoll J, Sharma R, Chiocchia V, Petersen SE, Frangou E, Ridgway G, Bhattacharyya S, Ripley DP, Woodward G, Leeson P. PROTEUS: A Prospective RCT Evaluating Use of AI in Stress Echocardiography. NEJM AI. 2024 Nov;1(11):AIoa2400865. doi: 10.1056/AIoa2400865. Epub 2024 Oct 18.
- Derived from this study: PubMed 38081671Fazakarley 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.
- Derived from this study: PubMed 37192698Woodward 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
20 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing EchoGo in people with Coronary Heart Disease, run by Ultromics Ltd at 20 sites in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 30 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 20 sites in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Investigate if EchoGo plus standard care is non-inferior to standard care alone for aiding referral to coronary angiogram following stress echocardiogram (SE) (time frame: 6 months post stress echo). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05028179, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Nov 2023.