Optimising a Digital Diagnostic Pathway for Heart Failure in the Community

NCT04724200 | Completed DMC

• 1 other identifier: INGN20CA503
• Study Type: observational
• Target: 867
• Locations: 1 country
• Sites: 1

Brief 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).

Conditions

Heart Failure

Keywords

echocardiogram; NTproBNP; digital diagnosis

Outcome Measures

Primary Outcomes (6)

• 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

Study Arms (1)

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

Interventions

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.

Referred from primary care for investigation of suspected heart failure

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

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

You may not qualify if:

• Individuals less than 18 years of age
• Individuals who have had an interim echocardiogram for another clinical reason, whilst on the outpatient echocardiogram waiting list for investigation of HF
• Individuals with a previous ICD-10 diagnosis of HF in any coding position
• 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
• Inability to read and understand the PIS (provided in English only), and understand the research team

Sponsors & Collaborators

• NHS Greater Glasgow and Clyde: lead
• University of Glasgow: collaborator

Study Sites (1)

NHS Louisa Jordan

Glasgow, G3 8YW, United Kingdom

Location

MeSH Terms

Conditions

Heart Failure

Interventions

Echocardiography

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Cardiac Imaging Techniques; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis; Ultrasonography; Heart Function Tests; Diagnostic Techniques, Cardiovascular

Study Officials

• Clare Murphy

  NHS Greater Glasgow and Clyde

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 5, 2021
• First Posted: January 26, 2021
• Study Start: January 5, 2021
• Primary Completion: August 27, 2021
• Study Completion: December 31, 2023
• Last Updated: March 28, 2024

Record last verified: 2024-03

Locations

GB (1)