Clinical trial NCT05558605: Use of Artificial Intelligence-Guided Echocardiography to assIst cardiovascuLar Patient managEment
Official title: Use of Artificial Intelligence-Guided Echocardiography to assIst cardiovascuLar Patient managEment
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Heart Failure
Valve Heart Disease
Keywords: Artificial intelligence
Echocardiography
Heart failure
Valve disease
Lead sponsor: Baker Heart and Diabetes Institute
Sponsor class: OTHER
Collaborators: name: Alice Springs Hospital
name: Princess Alexandra Hospital, Brisbane, Australia
name: Royal Perth Hospital
name: Ochre Health
name: Walgett Aboriginal Medical Services
name: Merriden Health Service
name: Royal Hobart Hospital
First posted: 2022-09-28
Enrollment: 612
Sex: ALL
Minimum age (years): 45
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Multicentre RCT comparing AI-TTE with usual care
Primary purpose: DIAGNOSTIC

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.

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

Primary outcomes:
measure: Diagnosis of cardiac dysfunction or heart valve disease
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Alice Springs
country: Australia
facility: Alice Springs Hospital
state: Northern Territory
Study officials:
affiliation: Baker Heart and Diabetes Institute
name: Tom Marwick, MBBS, PhD
role: PRINCIPAL_INVESTIGATOR
References: