None listed
Conditions
Brief summary
As the population ages, aortic stenosis (AS, a heart valve disease involving degeneration and obstruction of the aortic valve) is becoming an increasing problem. This condition is often unrecognized until patients present in a crisis. The goal of the ASSURE-ECHO study is to identify the feasibility and value of AI-guided and-interpreted echocardiography for screening for aortic stenosis in the community. The aims of the project are to confirm the feasibility of AI-guided echo acquisition and interpretation in rural and remote communities, and to show greater recognition of AS than through usual care.
Interventions
This trial will use artificial intelligence-based software (UltraSight, Boston, MA, and Caption Care, San Mateo, CA) to facilitate acquisition of a single 2D echocardiogram using standard ultrasound equipment (Lumify, Philips, Netherlands; Terason, Burlington, MA). The acquisition-artificial intelligence facilitates the decision to capture a 2-dimensional image based on recognising features pointing towards the adequacy of that image. These acquisitions will be obtained by non-experts (eg regist
This trial will use artificial intelligence-based software (UltraSight, Boston, MA, and Caption Care, San Mateo, CA) to facilitate acquisition of a single 2D echocardiogram using standard ultrasound equipment (Lumify, Philips, Netherlands; Terason, Burlington, MA). The acquisition-artificial intelligence facilitates the decision to capture a 2-dimensional image based on recognising features pointing towards the adequacy of that image. These acquisitions will be obtained by non-experts (eg registered nurses, general practitioners). The resulting 2D images will be interpreted by cardiologists in conjunction with artificial intelligence-based software (EchoCLIP, Cedars-Sinai, Los Angeles, CA). The interpretive artificial intelligence facilitates recognition of aortic stenosis by picking up patterns on the ultrasound image that are associated with aortic stenosis. It is planned to study 1000 people >65 years old over 12 months (August 2025-August 2026), in primary care and research facilities in Australia (Tasmania and possibly Victoria and Western Australia). All images will be collected by the core laboratory to assess the completeness of the echocardiogram and adequacy of interpretation.
Sponsors
University of Tasmania
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Diagnosis
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
65 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
Age >=65 years, Medicare-eligible, living in rural and remote communities (Monash category 2 and above)
Exclusion criteria
Known heart valve disease, comorbid conditions with life expectancy <2 years, inability to provide written informed consent.
Outcome results
None listed