This study investigates the clinical efficacy of a non-invasive screening protocol using AI-ECG and CT-ECV analysis for cardiac amyloidosis. The study targets on atrial fibrillation(AF) patients with "red-flag" indicators.
Participants are randomized 1:1 into either an early screening or usual care group.
* Early screening group : AI- ECG and/or CT-ECV analysis + AF treatment * Usual care group : AF treatment Both groups followed for 2 years to compare CA detection rates and clinical outcomes.
Adults aged 19 or older who have provided voluntary written informed consent.
Patients with a history of AF (paroxysmal or persistent) and one or more red-flag symptoms/signs.
Patients who can undergo at least one of the following: AI-ECG analysis or CT-ECV analysis.
Patients previously diagnosed with cardiac amyloidosis (AL or ATTR).
Patients with severe heart failure (NYHA class IV) or terminal illness with a life expectancy of less than 1 year.
Patients deemed inappropriate for participation by the investigator.
Parallel
AI-ECG analysis
Diagnostic testArtificial Intelligence-enhanced Electrocardiogram (AI-ECG), developed by Mayo Clinic, is gaining attention as a non-invasive screening tool. AI-ECG predicts myocardial amyloid deposition based on a standard 12-lead ECG with high accuracy, AUC 0.84(95% CI 0.82-0.86) In particular, it demonstrated superior performance with an AUC of 0.9 or higher in ECGs exhibiting low voltage or pseudo-infarction patterns, suggesting its potential to detect the disease even before structural changes become apparent.
CT-ECV analysis
Diagnostic testMyocardial Extracellular Volume (CT-ECV) analysis using cardiac CT is a tissue characterization technique that can be easily added to conventional cardiac CT protocols, enabling the quantification of myocardial fibrosis or infiltrative diseases. Among 874 subjects who underwent coronary CT, 12.4% exhibited a CT-ECV of ≥ 35%, and cardiac amyloidosis was incidentally discovered in 14.3% of these individuals.
Atrial fibrillation treatment
Other interventionStandard care and treatment in accordance with established AF guidelines.
Cardiac amyloidosis(CA) detection rate
CA detection rate in the early screening group based on AI-ECG and CT-ECV results The superiority hypothesis (detection rate of the early screening group \> control group) will be tested, utilizing the chi-squared test or Fisher's exact test as the primary analysis. Effect sizes will be reported as the difference in proportions, odds ratio (OR), and relative risk (RR), along with 95% CIs and p-values.
Diagnostic Sensitivity and Specificity of AI-ECG alone, CT-ECV alone, and the combined Model
Compare the diagnostic sensitivity and specificity of each model, the difference in proportions between groups will be analyzed as a primary analysis using the chi-squared test or Fisher's exact test. Furthermore, since the sensitivity and specificity of the AI-ECG, CT-ECV, and combined models are paired indicators derived from the same subjects, the McNemar test will be used for the comparison of sensitivity and specificity between models. In cases where it is necessary to adjust for covariates (e.g., age, sex, NT-proBNP) or to consider repeated measures/correlation structures, a logistic regression analysis based on Generalized Estimating Equations (GEE) with subject IDs as clusters will be performed to compare model effects.
Correlation of AI-ECG/CT-ECV values with other screening results in patients with confirmed CA
In patients with a confirmed CA, the association between AI-ECG scores/probabilities, CT-ECV (continuous), and clinical findings-such as biopsy results (if available), degree of DPD uptake (e.g., grade), and SPEP/UPEP/IFE results (positive/negative or quantitative values)-will be evaluated using Spearman correlation analysis and, if necessary, logistic or linear regression analysis.
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Samsung Medical Center
Lead sponsor
Mayo Clinic
Collaborator
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