This clinical trial evaluates an artificial intelligence (AI) enabled electrocardiogram (ECG) amyloid algorithm screening tool for improving the diagnosis of cardiac amyloidosis (CA). CA is uncommon and life-threatening, but treatable. Patients with CA are commonly misdiagnosed with other heart conditions which leads to poorer outcomes. Unfortunately, since CA is uncommon, providers often overlook the diagnosis. There is no simple screening test for CA and symptoms are often vague. Since most patients have an ECG done at some point, it is ideally suited to be used to promote the diagnosis of CA. The AI-enabled ECG screening tool uses an algorithm to identify those at greatest risk for a CA diagnosis and generates a report with recommendations for follow up. The AI ECG amyloid algorithm screening tool may provide decision support for clinicians and improve the diagnosis and survival of patients with CA.
Additional locations may be listed on ClinicalTrials.gov for NCT05557162.
See trial information on ClinicalTrials.gov for a list of participating sites.
PRIMARY OBJECTIVE:
I. To prospectively evaluate use of the AI ECG algorithm and the "augmented" amyloid AI ECG (A^3E) scores and an associated intervention (provider training, communication of results, and recommended tests) to enable early detection of CA in routine cardiology and hematology practices.
SECONDARY OBJECTIVES:
I. Assessment of performance across clinical settings (Mayo Clinic in Arizona [MCA], Mayo Clinic in Florida [MCF], Mayo Clinic in Rochester [MCR] [referral] versus Mayo Clinic Health System [MCHS] [community practice]).
II. Cardiology versus hematology practices.
III. Assessment of provider satisfaction with the intervention.
IV. Utilization of tests and calculation of costs associated with the intervention versus (vs.) standard of care.
OUTLINE: Providers are randomized to 1 of 2 arms.
ARM I: Providers view educational training videos over 30-60 minutes. Providers receive a patient's positive AI ECG algorithm score report, recommendations for further amyloid-specific testing to be ordered and a link to a webpage containing amyloid education and resources. Providers also receive up to 2 reminders at 2 week intervals if additional testing is not ordered and no reason is documented.
ARM II: Providers receive access to the AI ECG dashboard.
Trial PhaseNo phase specified
Trial Typescreening
Lead OrganizationMayo Clinic in Rochester
Principal InvestigatorAngela Dispenzieri
