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AI-Powered Electrocardiography for Diagnosis and Prognostic Prediction in Cardiovascular Disease (AI-CVD): Multicenter Retrospective Study

AI-Powered Electrocardiography for Diagnosis and Prognostic Prediction in Cardiovascular Disease (AI-CVD): Multicenter Retrospective Study

Recruiting
18 years and older
All
Phase N/A

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Overview

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.

Description

Cardiovascular diseases (CVDs) remain a leading cause of global morbidity and mortality. Standard 12-lead ECGs are widely accessible tools for cardiovascular screening and diagnosis; however, traditional visual interpretations have limitations. Recent advancements in deep learning offer unprecedented performance in extracting hidden patterns from ECG signals.

This study is a retrospective, multicenter investigation conducted across multiple tertiary medical centers in South Korea. The primary objectives are:

  • To extract and encrypt raw 12-lead ECG data (XML format) into binary datasets to ensure patient privacy and data standardization.
  • To advance and validate deep neural network models-specifically combining Bi-LSTM and attention mechanisms-for diagnosing conditions such as coronary artery disease, heart failure, and related structural heart diseases.
  • To assess the clinical utility and prognostic performance of AI-ECG risk prediction models in real-world cohorts spanning data from 2005 to 2022.

Eligibility

Inclusion Criteria:

  • 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

Exclusion Criteria:

\- Patients deemed inappropriate as study subjects by the investigator's judgment

Study details
    Cardiovascular Diseases
    Coronary Artery Disease
    Heart Failure
    Atrial Fibrillation (AF)
    Ventricular Hypertrophy

NCT07856472

Inha University Hospital

20 October 2026

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