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

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorInha University Hospital

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 volunteers

Qualifiers

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

Design model

Cohort

Time perspective

Other

Treatments tested in this trial

  • Retrospective ECG Data Analysis

    Other intervention

    Analysis of de-identified 12-lead electrocardiogram raw data using deep learning models for cardiovascular disease diagnosis and prognosis.

Treatment groups

10,000 Participants
are divided into 1 treatment group
Group A: Cardiovascular Disease Cohort1 intervention

Trial outcomes

Primary outcomes

1

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.

Time frame
Baseline

Secondary outcomes

1

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.

Time frame
Baseline

Other outcomes

Sponsors and contacts

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