Use of Artificial Intelligence-Guided Echocardiography to assIst cardiovascuLar Patient managEment (AGILE-Echo)

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.

Study Overview

• Status: Recruiting
• Conditions: Heart Failure; Valve Heart Disease
• Intervention / Treatment: Diagnostic test: AI-guided echo; Diagnostic test: Standard echo

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Anticipated): 612
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Tom Marwick, MBBS, PhD; Phone Number: +61385321550; Email: tom.marwick@baker.edu.au

Study Locations

• Australia
  • Northern Territory
    • Alice Springs, Northern Territory, Australia
      • Recruiting
      • Alice Springs Hospital
      • Contact: Angus Baumann, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 45 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / 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 Measures

Outcome Measure	Measure Description	Time Frame
Diagnosis of cardiac dysfunction or heart valve disease	Number of Participants with Diagnosis of cardiac dysfunction or heart valve disease	12 months

Collaborators and Investigators

• Sponsor: Baker Heart and Diabetes Institute
• Collaborators: Princess Alexandra Hospital, Brisbane, Australia; Royal Perth Hospital; Alice Springs Hospital; Nepean Blue Mountains Local Health District; Ochre Health
• Investigators: Principal Investigator: Tom Marwick, MBBS, PhD, Baker Heart and Diabetes Institute

Study record dates

Study Major Dates

• Study Start (Actual): February 24, 2023
• Primary Completion (Anticipated): December 30, 2025
• Study Completion (Anticipated): December 30, 2025

Study Registration Dates

• First Submitted: September 11, 2022
• First Submitted That Met QC Criteria: September 25, 2022
• First Posted (Actual): September 28, 2022

Study Record Updates

• Last Update Posted (Estimate): March 3, 2023
• Last Update Submitted That Met QC Criteria: March 1, 2023
• Last Verified: December 1, 2022

More Information

Terms related to this study

• Keywords: Heart failure; Echocardiography; Artificial intelligence; Valve disease
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Heart Failure; Heart Diseases; Heart Valve Diseases
• Other Study ID Numbers: 325-22

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes