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Use of Artificial Intelligence-Guided Echocardiography to assIst cardiovascuLar Patient managEment

RECRUITING

Heart Failure and valvular heart disease are disproportionate problems in rural and remote Australia (RRA). Echocardiography is the best imaging investigation, and essential for management, but access to this essential test shows huge geographic variations, primarily because of dependence on expert acquisition. This trial seeks to demonstrate the effectiveness of artificial intelligence-based echocardiography for triage and management of patients with known or suspected heart disease in RRA.

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Study details:

Heart Failure (HF) and valvular heart disease (VHD) are disproportionate problems in rural and remote Australia (RRA) relative to the rest of the country, due in part to an ageing rural population and to the frequency of rheumatic heart disease in the Aboriginal community. Late diagnoses can lead to avoidable hospital admissions and expense to the Australian health system. Echocardiography is the imaging investigation of choice, and a cornerstone of management, but access to this essential test shows huge geographic variations in Australia.

The primary reason for this is the dependence of this technique on expert acquisition. Artificial intelligence (AI) has now been harnessed to optimise echocardiographic image acquisition, and secure, cloud-based storage enables remote measurement and interpretation. This trial seeks to demonstrate the effectiveness of AI-based echocardiography-guided triage and management of patients with known or suspected heart disease in RRA.

This study will involve the conduct of a world-first randomised controlled trial of AI-testing and early intervention to detect early stages of HF and VHD, select appropriate management, reduce admissions and preserve functional status and quality of life. The study will be conducted with partipants in RRA, aged 40 years and older with at least one HF risk factor and recruited through clinic and community outreach in four sites with the involvement of remote outreach from i) Alice Springs Hospitals, ii) Nepean Hospital to Dubbo Hospital and Western NSW, iii) Princess Alexandra Hospital to Roma, Charleville and Western Queensland, and iv) Perth Aboriginal communities in partnership with the Royal Perth hospital and the Derbarl Yerrigan Health Service. Approximately 1200 individuals at risk for HF and VHD will be screened and followed up.

The study will be conducted in partnership with Aboriginal community partners.

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Eligibility criteria

Researchers look for people who fit a certain description, called eligibility criteria. See if you qualify.

Inclusion criteria

  • Age >45 years
  • eligible for Medicare
  • exercise intolerance or cardiovascular (CV) risk factors
  • Exclusion criteria

  • Known HF or HVD
  • situations where cardio-protection is already indicated (eg. known CAD)
  • comorbid conditions with life expectancy <2 years
  • inability to provide written informed consent
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    Eligibility

    Age eligible for study : 45 and older

    Healthy volunteers accepted : No

    Gender eligible for study: All

    Things to know

    Study dates

    Study start: 2023-02-24

    Primary completion: 2025-12-30

    Study completion finish: 2025-12-30

    study type

    Study type

    DIAGNOSTIC

    phase

    Phase

      NA

    trial

    Trial ID

    NCT05558605

    Intervention or treatment

    DIAGNOSTIC_TEST: AI-guided echo

    DIAGNOSTIC_TEST: Standard echo

    Conditions

    • Heart Failure
    • Valve Heart Disease
    Image related to Heart Failure
    • Condition: Heart Failure, Valve Heart Disease

    • DIAGNOSTIC_TEST: AI-guided echo and other drugs

    • Alice Springs, Northern Territory, Australia

    • Sponsor: Baker Heart and Diabetes Institute

    Find a site

    Closest Location:

    Alice Springs Hospital

    Research sites nearby

    Select from list below to view details:

    • Alice Springs Hospital

      Alice Springs, Northern Territory, Australia

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    Study Plan

    This section provides details of the study plan, including how the study is designed and what the study is measuring.

    How is the study designed?

    Participant Group/ArmIntervention/Treatment
    EXPERIMENTAL: Screening/Management Plan
    • AI-guided echo acquisition performed using a desktop echo machine (uSmart 3300, Terason, Burlington, MA) with AI software (Caption Health, Brisbane, CA) obtained by a non-expert (eg. clinic nurse, registrar general practitioner or physician) at the remote clinic, usually on the day of clinic review. Images will then be uploaded onto a secure cloud and downloaded at the core lab for measurement, interpretation and reporting.
    DIAGNOSTIC_TEST: AI-guided echo
    • AI-guided echocardiography
    ACTIVE_COMPARATOR: Usual care
    • Standard echo acquisition by a sonographer either at a referral hospital, or by a visiting team - usually necessitating a delay. Measurement, interpretation and reporting will happen as usual.
    DIAGNOSTIC_TEST: Standard echo
    • Standard echocardiography

    What is the study measuring?

    Primary outcome

    Primary Outcome MeasurePrimary Outcome DescriptionPrimary Outcome Time Frame
    Diagnosis of cardiac dysfunction or heart valve diseaseNumber of Participants with Diagnosis of cardiac dysfunction or heart valve disease12 months

    Secondary outcome

    Frequently Asked Questions

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    References

    Clinical Trials Gov: Use of Artificial Intelligence-Guided Echocardiography to assIst cardiovascuLar Patient managEment

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