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NCT Number: NCT05558605

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

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.

Recruiting

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Key information

Age range

45 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Alice Springs Hospital

Alice Springs, Northern Territory, Australia

Location status: Recruiting

Location contact

Angus Baumann, MD

CONTACT

About this study

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.

Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

AI-guided echo

Diagnostic Test

AI-guided echocardiography

Standard echo

Diagnostic Test

Standard echocardiography

Primary outcomes

  1. Diagnosis of cardiac dysfunction or heart valve disease

    Time frame: 12 months

    Number of Participants with Diagnosis of cardiac dysfunction or heart valve disease

Study contacts

Contact information is provided by the study sponsor or research team.

Tom Marwick, MBBS, PhD

CONTACT

[email protected]

+61385321550

Sponsors and collaborators

Lead sponsor

Baker Heart and Diabetes Institute

Other

Collaborators

  • Alice Springs Hospital
  • Merriden Health Service
  • Ochre Health
  • Princess Alexandra Hospital, Brisbane, Australia
  • Quairading Medical Practice
  • Royal Hobart Hospital
  • Royal Perth Hospital
  • Walgett Aboriginal Medical Services

Registry information

Acronym: AGILE-Echo

Important dates

Study start
2023
Primary completion
2026
Study completion
2026
First posted
Sep 28, 2022
Registry last updated
Oct 20, 2025

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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