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

Heart Failure Clinical Trial

— AGILE-Echo  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05558605
• Other study ID #: 325-22
• Status: Recruiting
• Phase: N/A
• Start date: February 24, 2023
• Est. completion date: December 30, 2025

Study information

• Verified date: December 2022
• Source: Baker Heart and Diabetes Institute
• Contact: Tom Marwick, MBBS, PhD
• Phone: +61385321550
• Email: tom.marwick[@]baker.edu.au
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 612
• Est. completion date: December 30, 2025
• Est. primary completion date: December 30, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 45 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Heart Diseases
• Heart Failure
• Heart Valve Diseases
• Valve Heart Disease

Intervention

Diagnostic Test:
• AI-guided echo
AI-guided echocardiography
• Standard echo
Standard echocardiography

Locations

Country	Name	City	State
Australia	Alice Springs Hospital	Alice Springs	Northern Territory

Sponsors (6)

Lead Sponsor	Collaborator
Baker Heart and Diabetes Institute	Alice Springs Hospital, Nepean Blue Mountains Local Health District, Ochre Health, Princess Alexandra Hospital, Brisbane, Australia, Royal Perth Hospital

Country where clinical trial is conducted

Australia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Diagnosis of cardiac dysfunction or heart valve disease	Number of Participants with Diagnosis of cardiac dysfunction or heart valve disease	12 months