About this trial
This multicenter retrospective study aims to develop, validate, and clinically apply an artificial intelligence (AI)-powered electrocardiography (ECG) algorithm for the diagnosis and prognostic prediction of cardiovascular diseases, including coronary artery disease and heart failure. By utilizing encrypted raw 12-lead ECG text data and deep neural network models, the study evaluates the effectiveness of AI-enhanced ECG in detecting cardiac abnormalities and predicting clinical outcomes.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Patients aged 18 years or older diagnosed with cardiovascular diseases, including coronary artery disease and heart failure.
Patients with 12-lead electrocardiogram (ECG) records extractable as text (XML
Disqualifiers
None
Trial population
Patients visiting the participating tertiary hospitals with extractable electrocardiogram records and diagnosed with cardiovascular diseases.
Trial design
Cohort
Other
Treatments tested in this trial
Retrospective ECG Data Analysis
Other interventionAnalysis of de-identified 12-lead electrocardiogram raw data using deep learning models for cardiovascular disease diagnosis and prognosis.
Treatment groups
Trial outcomes
Primary outcomes
Diagnostic Performance (AUC-ROC) of AI-ECG Models
To evaluate the area under the receiver operating characteristic curve (AUC-ROC) of the deep neural network-based 12-lead ECG model for diagnosing cardiovascular diseases compared to reference clinical standards.
Secondary outcomes
Sensitivity and Specificity of AI-ECG Models
To evaluate the association between AI-ECG risk scores and long-term clinical outcomes, including all-cause mortality and heart failure-related hospitalizations.
Sponsors and contacts
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