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Completed

NCT Number: NCT04724200

Optimising a Digital Diagnostic Pathway for Heart Failure in the Community

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).

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Key information

Conditions

Heart Failure Cardiovascular Diseases Heart Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

NHS Louisa Jordan

Glasgow, G3 8YW, United Kingdom

About this study

  • 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.
  • 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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

  • 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

Treatment and study plan

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.

Primary outcomes

  1. Negative and positive predictive value (NPV and PPV)

    Time frame: 1 day

    NPV and PPV describe the proportions of postive and negative results that are true results

  2. False positive

    Time frame: 1 day

    A results that wrongly indicates heart failure is present in the OPERA patient

  3. False negative

    Time frame: 1 day

    A result that wrongly indicates heart failure is not present in the OPERA patient

  4. sensitivity

    Time frame: 1 day

    the ability of a diagnostics test to correctly identify those with heart failure

  5. specificity

    Time frame: 1 day

    the ability of a diagnostic test to correctly identify those without heart failure

  6. Area under curve

    Time frame: 1 day

    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

Sponsors and collaborators

Lead sponsor

NHS Greater Glasgow and Clyde

Other

Collaborators

  • University of Glasgow

Registry information

Acronym: OPERA

Important dates

Study start
2021
Primary completion
2021
Study completion
2023
First posted
Jan 26, 2021
Registry last updated
Mar 28, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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