AI Echocardiographic Screening of Cardiac Amyloidosis

Cedars-Sinai Medical Center

Status: Invitation-only

Conditions: Cardiac Amyloidosis

Treatments: Diagnostic Test: EchoNet-LVH Assessment

Study type: Interventional

Funder types: Other

Identifiers

NCT06664866

Study1720

Details and patient eligibility

About

Recent advances in machine learning and image processing techniques have shown that machine learning models can identify features unrecognized by human experts and accurately assess common measurements made in clinical practice. Echocardiography is the most common form of cardiac imaging and is routinely and frequently used for diagnosis. However, there is often subjectivity and heterogeneity in interpretation. Artificial intelligence (AI)'s ability for precision measurement and detection is important in both disease screening as well as diagnosis of cardiovascular disease.

Cardiac amyloidosis (CA) is a rare, underdiagnosed disease with targeted therapies that reduce morbidity and increase life expectancy. However, CA is frequently overlooked and confused with heart failure with preserved ejection fraction. Some estimates suggest that CA can be as prevalence as 1% in a general population, with even higher prevalence in patients with left ventricular hypertrophy, heart failure, and other cardiac symptoms that might prompt echocardiography.

AI guided disease screening workflows have been proposed for rare diseases such as cardiac amyloidosis and other diseases with relatively low prevalence but significant human impact with targeted therapies when detected early. This is an area particularly suitable for AI as there are multiple mimics where diseases like hypertrophic cardiomyopathy, cardiac amyloidosis, aortic stenosis, and other phenotypes might visually be similar but can be distinguished by AI algorithms. The investigators have developed an algorithm, termed EchoNet-LVH, to identify cardiac hypertrophy and identify patients who would benefit from additional screening for cardiac amyloidosis.

Enrollment: 500 estimated patients

Sex: All

Ages: 22+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients receiving an echocardiogram that is determined to be suspicious by EchoNet-LVH

Exclusion criteria

• Patients that decline consent
• Patients receiving an echocardiogram that is determined to be not suspicious by EchoNet-LVH

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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500 participants in 1 patient group

Suspicious by EchoNet-LVH Algorithm

Experimental group

Description:

Each potential participant identified by automated AI-enhanced echocardiogram review will be chart reviewed by each site's CA experts for appropriateness of enrollment and clinican suspicion for CA. Based on the judgement of CA experts, potential participants that meet eligibility criteria will be called to be consented, followed in the study, and referred to see the CA expert.

Treatment:

Diagnostic Test: EchoNet-LVH Assessment