AI assessment of patients with suspected Coronary Artery Disease (CAD) Circulatory System Atherosclerotic heart disease
Conditions
Interventions
Eligible patients will be randomised using a secure online randomisation tool. Participants will be randomised 1:1 to receive 1) standard care (comparator) or 2) AI supported standard care (interve
Sponsors
Ultromics Ltd
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Willing and able to provide informed consent 2. Male or female, =18 years of age at study entry 3. Referred to an NHS Trust for stress echocardiography for investigation of ischaemic heart disease
Exclusion criteria
Exclusion criteria: 1. More than moderate valvular heart disease 2. Left ventricular outflow tract obstruction defined as a gradient > 30mmHg (fixed or dynamic; supravalvular, valvular or sub-valvular) 3. Significant co-morbidities (e.g. cancer) with an expected life-expectancy of under 12 months in the investigator's opinion 4. Previous coronary artery bypass graft or other cardiac surgery 5. Congenital or inherited myocardial disease
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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. | — |
Secondary
| Measure | Time frame |
|---|---|
| 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 ang | — |
Countries
England, United Kingdom
Contacts
Public ContactBen Thompson
Outcome results
None listed