NCT04724200

Optimising a Digital Diagnostic Pathway for Heart Failure in the Community

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 867 (actual)
• Sponsor: NHS Greater Glasgow and Clyde · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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).

Detailed 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.

Conditions

• Heart Failure

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	Echocardiogram	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.

Timeline

• Start date: 2021-01-05
• Primary completion: 2021-08-27
• Completion: 2023-12-31
• First posted: 2021-01-26
• Last updated: 2024-03-28

Locations

1 site across 1 country: United Kingdom