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

NCT05558605 | Recruiting FDA Device

• 1 other identifier: 325-22
• Study Type: interventional
• Target: 612
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Heart Failure; Valve Heart Disease

Keywords

Artificial intelligence; Echocardiography; Heart failure; Valve disease

Outcome Measures

Primary Outcomes (1)

• Diagnosis of cardiac dysfunction or heart valve disease

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

  12 months

Study Arms (2)

Screening/Management Plan

EXPERIMENTAL

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

Usual care

ACTIVE COMPARATOR

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

Interventions

AI-guided echo DIAGNOSTIC_TEST

AI-guided echocardiography

Screening/Management Plan

Standard echo DIAGNOSTIC_TEST

Standard echocardiography

Usual care

Eligibility Criteria

• Age: 45 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Baker Heart and Diabetes Institute: lead
• Alice Springs Hospital: collaborator
• Princess Alexandra Hospital, Brisbane, Australia: collaborator
• Royal Perth Hospital: collaborator
• Ochre Health: collaborator
• Walgett Aboriginal Medical Services: collaborator
• Merriden Health Service: collaborator
• Royal Hobart Hospital: collaborator
• Quairading Medical Practice: collaborator

Study Sites (1)

Alice Springs Hospital

Alice Springs, Northern Territory, Australia

RECRUITING

MeSH Terms

Conditions

Heart Failure; Heart Valve Diseases

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Study Officials

• Tom Marwick, MBBS, PhD

  Baker Heart and Diabetes Institute

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Tom Marwick, MBBS, PhD

CONTACT

+61385321550; tom.marwick@baker.edu.au

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: PROBE design
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Multicentre RCT comparing AI-TTE with usual care

Study Record Dates

• First Submitted: September 11, 2022
• First Posted: September 28, 2022
• Study Start: February 24, 2023
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): June 30, 2026
• Last Updated: October 20, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

AU (1)