Optimising a Digital Diagnostic Pathway for Heart Failure in the Community (OPERA)

NHS Trust

Status: Completed

Conditions: Heart Failure

Treatments: Diagnostic Test: Echocardiogram

Study type: Observational

Funder types: Other

Identifiers

NCT04724200

INGN20CA503

Details and patient eligibility

About

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).

Full description

1. Demonstrate that in comparison to using the current gold standard of BSE accredited operator echocardiography within a HFDP, using AI enhanced analysis of POC handheld echocardiography is accurate and safe. This has the potential to improve access to timelier echocardiography in order to achieve earlier HF diagnosis and treatment, which is known to delay/prevent progression to HF hospitalisation. It will also provide useful information regarding the future feasibility of using AI enhanced analysis of POC handheld echocardiography in the community, for investigation of people with suspected new HF.
2. Facilitate the digitisation of an NHS Heart Failure diagnostic service in order to standardise and improve the quality of data collection and clinical care provided within the service.

Enrollment: 867 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Adult individuals referred from the community who are awaiting HF diagnostic investigations, including echocardiography, to investigate for a suspected new diagnosis of HF

Exclusion criteria

1. Individuals less than 18 years of age
2. Individuals who have had an interim echocardiogram for another clinical reason, whilst on the outpatient echocardiogram waiting list for investigation of HF
3. Individuals with a previous ICD-10 diagnosis of HF in any coding position
4. Inability of the participant, in the opinion of the investigators, to understand and/or comply with study procedures, or any conditions that, in the opinion of the investigators, may render the participant unable to understand, attend and/or undergo study visit investigations
5. Inability to read and understand the PIS (provided in English only), and understand the research team

Trial design

867 participants in 1 patient group

Referred from primary care for investigation of suspected heart failure

Description:

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.

Treatment:

Diagnostic Test: Echocardiogram