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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04724200
Recruitment Status : Unknown
Verified January 2021 by NHS Greater Glasgow and Clyde.
Recruitment status was:  Recruiting
First Posted : January 26, 2021
Last Update Posted : January 26, 2021
Sponsor:
Collaborator:
University of Glasgow
Information provided by (Responsible Party):
NHS Greater Glasgow and Clyde

Study Description
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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).

Condition or disease Intervention/treatment
Heart Failure 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 Design
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Study Type : Observational
Estimated Enrollment : 864 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Optimising a Digital Diagnostic Pathway for Heart Failure in the Community
Actual Study Start Date : January 5, 2021
Estimated Primary Completion Date : April 30, 2021
Estimated Study Completion Date : December 31, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Failure

Groups and Cohorts
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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.


Outcome Measures
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Primary Outcome Measures :
  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


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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.

Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04724200


Contacts
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Contact: Katriona Brooksbank, PhD 07891318513 katriona.brooksbank@glasgow.ac.uk
Contact: Clare Murphy clare.murphy@ggc.scot.nhs.uk

Locations
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United Kingdom
NHS Louisa Jordan Recruiting
Glasgow, United Kingdom, G3 8YW
Contact: Barbara Meyer, BSc       barbara.meyer@ggc.scot.nhs.uk   
Sponsors and Collaborators
NHS Greater Glasgow and Clyde
University of Glasgow
Investigators
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Principal Investigator: Clare Murphy NHS Greater Glasgow and Clyde
More Information
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Responsible Party: NHS Greater Glasgow and Clyde
ClinicalTrials.gov Identifier: NCT04724200    
Other Study ID Numbers: INGN20CA503
First Posted: January 26, 2021    Key Record Dates
Last Update Posted: January 26, 2021
Last Verified: January 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: To be confirmed

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by NHS Greater Glasgow and Clyde:
echocardiogram
NTproBNP
digital diagnosis
Additional relevant MeSH terms:
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Heart Failure
Heart Diseases
Cardiovascular Diseases