Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| University of Glasgow | OTHER |
Not provided
Not provided
Not provided
Not provided
This is a prospective, observational study. The primary aim is to assess the diagnostic accuracy of Artificial Intelligence (AI) analysis of Point of Care (POC) handheld transthoracic echocardiogram images (POC handheld echocardiogram) compared to the current gold-standard of transthoracic echocardiogram images acquired and analysed by a British Society of Echocardiography (BSE) accredited operator, using a standard echocardiogram machine (standard TTE), for the diagnosis of Heart Failure with reduced Ejection Fraction (HFrEF), in patients referred from the community for investigation of suspected new Heart Failure (HF).
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Referred from primary care for investigation of suspected heart failure | All patients recruited to the OPERA trial will have been referred from their primary care clinician for investigation of a suspected diagnosis of heart failure. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Echocardiogram | Diagnostic Test | Echocardiography plays a crucial role in the diagnosis of HF; it is the standard of care imaging modality used to confirm the diagnosis, it permits real-time imaging of the heart and quantitative assessment of cardiac structure and function, crucial for diagnosis. |
| Measure | Description | Time Frame |
|---|---|---|
| Negative and positive predictive value (NPV and PPV) | NPV and PPV describe the proportions of postive and negative results that are true results | 1 day |
| False positive | A results that wrongly indicates heart failure is present in the OPERA patient | 1 day |
| False negative | A result that wrongly indicates heart failure is not present in the OPERA patient | 1 day |
| sensitivity | the ability of a diagnostics test to correctly identify those with heart failure | 1 day |
| specificity | the ability of a diagnostic test to correctly identify those without heart failure | 1 day |
| Area under curve | area under receiver operator curve comparison of the standard TTE Vs AI analysed POC echocardiogram for the diagnosis of HFrEF in people referred from the community for investigation of suspected new HF | 1 day |
Not provided
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
864 participants, who have been referred for echocardiography to investigate a suspected new diagnosis of HF, but who have not been able to undergo echocardiographic testing yet due to additional barriers and delays to access imposed by the COVID-19 pandemic, will be recruited from the HF diagnostic pathway waiting list in NHS Greater Glasgow and Clyde between 1st December 2020 and 31st March 2021.
Study visits would normally be undertaken within NHS Greater Glasgow and Clyde hospitals. For public health physical distancing compliance reasons, study visits will take place in the NHS Louisa Jordan hospital (situated within the Scottish Exhibition and Conference Centre), temporarily converted for NHS clinical use to manage demand vs capacity issues during the COVID-19 pandemic.
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Clare Murphy | NHS Greater Glasgow and Clyde | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| NHS Louisa Jordan | Glasgow | G3 8YW | United Kingdom |
To be confirmed
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D006333 | Heart Failure |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D004452 | Echocardiography |
| ID | Term |
|---|---|
| D057791 | Cardiac Imaging Techniques |
| D003952 | Diagnostic Imaging |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
Not provided
Not provided
Not provided
Not provided
Not provided
|
| D014463 | Ultrasonography |
| D006334 | Heart Function Tests |
| D003935 | Diagnostic Techniques, Cardiovascular |