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

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).

Study Overview

• Status: Completed
• Conditions: Heart Failure
• Intervention / Treatment: Diagnostic test: Echocardiogram

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.

• Study Type: Observational
• Enrollment (Actual): 867

Contacts and Locations

• Study Contact: Name: Katriona Brooksbank, PhD; Phone Number: 07891318513; Email: katriona.brooksbank@glasgow.ac.uk
• Study Contact Backup: Name: Clare Murphy; Email: clare.murphy@ggc.scot.nhs.uk

Study Locations

• United Kingdom
  • Glasgow, United Kingdom, G3 8YW
    • NHS Louisa Jordan

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

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.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Collaborators and Investigators

• Sponsor: NHS Greater Glasgow and Clyde
• Collaborators: University of Glasgow
• Investigators: Principal Investigator: Clare Murphy, NHS Greater Glasgow and Clyde

Study record dates

Study Major Dates

• Study Start (Actual): January 5, 2021
• Primary Completion (Actual): August 27, 2021
• Study Completion (Actual): December 31, 2023

Study Registration Dates

• First Submitted: January 5, 2021
• First Submitted That Met QC Criteria: January 25, 2021
• First Posted (Actual): January 26, 2021

Study Record Updates

• Last Update Posted (Actual): March 28, 2024
• Last Update Submitted That Met QC Criteria: March 27, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Keywords: NTproBNP; echocardiogram; digital diagnosis
• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Heart Failure
• Other Study ID Numbers: INGN20CA503

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: To be confirmed

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No