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

Current primary outcome measure as of 26/05/2022:
AUROC for the ability to make an appropriate referral to coronary angiogram measured using medical record review at 3 and 6 months


Previous primary outcome measure:
Assessment of whether appropriate clinical management has been achieved at 6 months post visit through medical record review at 3 and 6 months.

Current secondary outcome measures as of 26/05/2022:
1. Appropriate clinical management at 6 months following stress echocardiogram (SE) measured using medical record review at 3 and 6 months. Appropriate management will be defined as a composite of:
1.1. If, following a stress echo, the decision was made to refer the patient for a coronary angiogram, the outcome will be positive if the coronary angiography demonstrates severe coronary disease fulfilling clinical care guidelines for revascularisation, or
1.2. If, following a stress echo, the decision was made not to refer the patient for coronary angiography, but rather, the patient to have medical management, the outcome will be positive if the follow up of participant health provides reassurance without unanticipated serious adverse cardiac events
2. Number of acute coronary events not related to elective cardiac procedures occurring up to 6 months following SE measured using medical record review at 6 months. Acute coronary events are defined as:
2.1. Myocardial Infarction Type 3 (ECS universal definition), and
2.2. Hospital admission with Myocardial Infarction Type 1 (ESC universal definition)
3. Change in clinical management decision following review of the EchoGo report measured using clinician self-report at baseline, 3 months, and the end of study at each participating site
4. Clinician diagnostic confidence in their interpretation of the stress echo report measured using clinician self-report at baseline, 3 months, and the end of study at each participating site
5. Inter-clinician and in-site variability measured at baseline, 3 months, and at end of study
6. Incidences of the following (occurring up to 6 months following stress echo) measured using medical record review at 3 and 6 months:
6.1. Myocardial Perfusion Scan
6.2. CT coronary angiogram
6.3. Stress echo
6.4. Invasive coronary angiogram
6.5. Stress CMR
6.6. Exercise tolerance test
6.7. Initiation of anti-anginal medication/medical management of angina
7. Coronary artery disease symptoms and impact on participant health status as measured using patient-reported short Seattle Angina Questionnaire (SAQ-7) at trial entry, 3 months and 6 months
8. Intervention cost benefit as defined by individual-level data conducted from the health system perspective from randomisation to follow-up at 6 months
9. Change in health-related Quality of Life measured using patient-reported EQ-5D-5L at trial entry, 3 months and 6 months


Previous secondary outcome measures:
1. Assessment of whether appropriate clinical management has been achieved at 6 months post visit through medical record review at 3 and 6 months.
2. Numbers of unanticipated acute cardiac events (not related to elective procedures) in NHS sites collected at 6 months post baseline visit.
3. Impact on clinical management decision making by review of the EchoGo report measured through comparison of the trial arm and comparator arm at 6 months post baseline visit.
4. Clinician diagnostic confidence in their interpretation of the stress echo report measured by clinician self-report at baseline, 3 months and end of study at each participating site.
5. Inter-clinician and in-site variability in measured at baseline, 3 months and at end of study.
6. Data on incidences of further diagnostic testing (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) occurring up to 6 months following stress echo collected from participants medical records at 3 and 6 months.
7. Coronary artery disease symptoms and impact on participant health status measured by patient-reported short Seattle Angina Questionnaire (SAQ-7) at trial entry, 3 months and 6 months.
8. Health economic impact of EchoGo implementation assessed through cost benefit analysis (as defined by individual-level data conducted from the health system perspective), and changes in health-related quality of life (EQ-5D-5L) at baseline, 3 and 6 months.