Optimising a Digital Diagnostic Pathway for Heart Failure in the Community

Heart Failure Clinical Trial

— OPERA  

Official title:

Optimising a Digital Diagnostic Pathway for Heart Failure in the Community

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04724200
• Other study ID #: INGN20CA503
• Status: Completed
• Start date: January 5, 2021
• Est. completion date: December 31, 2023

Study information

• Verified date: March 2024
• Source: NHS Greater Glasgow and Clyde
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 867
• Est. completion date: December 31, 2023
• Est. primary completion date: August 27, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Heart Failure

Intervention

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.

Locations

Country	Name	City	State
United Kingdom	NHS Louisa Jordan	Glasgow

Sponsors (2)

Lead Sponsor	Collaborator
NHS Greater Glasgow and Clyde	University of Glasgow

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	False positive	A results that wrongly indicates heart failure is present in the OPERA patient	1 day
Primary	False negative	A result that wrongly indicates heart failure is not present in the OPERA patient	1 day
Primary	sensitivity	the ability of a diagnostics test to correctly identify those with heart failure	1 day
Primary	specificity	the ability of a diagnostic test to correctly identify those without heart failure	1 day
Primary	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