AI Echocardiographic Screening for Cardiac Amyloidosis

Recruiting in Palo Alto (17 mi)

+3 other locations

Overseen byDavid Ouyang, MD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Waitlist Available

Sponsor: Cedars-Sinai Medical Center

No Placebo Group

Trial Summary

What is the purpose of this trial?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.

Eligibility Criteria

This trial is for individuals who may have cardiac amyloidosis, a rare heart condition often mistaken for other types of heart failure. It's especially aimed at those with symptoms or conditions that could be related to this disease and would typically undergo echocardiography.

Inclusion Criteria

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

Exclusion Criteria

I have chosen not to give my consent for participation.

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

Participant Groups

The trial is testing an AI algorithm called EchoNet-LVH designed to improve the detection of cardiac amyloidosis using routine echocardiogram images. The goal is to see if this technology can more accurately identify patients who need further screening.

1Treatment groups

Experimental Treatment

Group I: Suspicious by EchoNet-LVH AlgorithmExperimental Treatment1 Intervention

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.