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

Primary Purpose

Heart Failure, Valve Heart Disease

Status
Recruiting
Phase
Not Applicable
Locations
Australia
Study Type
Interventional
Intervention
AI-guided echo
Standard echo
Sponsored by
Baker Heart and Diabetes Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Heart Failure focused on measuring Artificial intelligence, Echocardiography, Heart failure, Valve disease

Eligibility Criteria

45 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Alice Springs HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Screening/Management Plan

Usual care

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
September 11, 2022
Last Updated
March 1, 2023
Sponsor
Baker Heart and Diabetes Institute
Collaborators
Alice Springs Hospital, Princess Alexandra Hospital, Brisbane, Australia, Royal Perth Hospital, Nepean Blue Mountains Local Health District, Ochre Health
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1. Study Identification

Unique Protocol Identification Number
NCT05558605
Brief Title
Use of Artificial Intelligence-Guided Echocardiography to assIst cardiovascuLar Patient managEment
Acronym
AGILE-Echo
Official Title
Use of Artificial Intelligence-Guided Echocardiography to assIst cardiovascuLar Patient managEment
Study Type
Interventional

2. Study Status

Record Verification Date
December 2022
Overall Recruitment Status
Recruiting
Study Start Date
February 24, 2023 (Actual)
Primary Completion Date
December 30, 2025 (Anticipated)
Study Completion Date
December 30, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Baker Heart and Diabetes Institute
Collaborators
Alice Springs Hospital, Princess Alexandra Hospital, Brisbane, Australia, Royal Perth Hospital, Nepean Blue Mountains Local Health District, Ochre Health

4. Oversight

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
Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Heart Failure, Valve Heart Disease
Keywords
Artificial intelligence, Echocardiography, Heart failure, Valve disease

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Multicentre RCT comparing AI-TTE with usual care
Masking
Outcomes Assessor
Masking Description
PROBE design
Allocation
Randomized
Enrollment
612 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Screening/Management Plan
Arm Type
Experimental
Arm Description
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.
Arm Title
Usual care
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Diagnostic Test
Intervention Name(s)
AI-guided echo
Intervention Description
AI-guided echocardiography
Intervention Type
Diagnostic Test
Intervention Name(s)
Standard echo
Intervention Description
Standard echocardiography
Primary Outcome Measure Information:
Title
Diagnosis of cardiac dysfunction or heart valve disease
Description
Number of Participants with Diagnosis of cardiac dysfunction or heart valve disease
Time Frame
12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Tom Marwick, MBBS, PhD
Phone
+61385321550
Email
tom.marwick@baker.edu.au
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Tom Marwick, MBBS, PhD
Organizational Affiliation
Baker Heart and Diabetes Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
Alice Springs Hospital
City
Alice Springs
State/Province
Northern Territory
Country
Australia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Angus Baumann, MD

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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