External Validation of Artificial Intelligence-enabled Electrocardiography (AI-ECG) for the Detection of Left Ventricular Dysfunction (LVD)

Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-100
SponsorTri-Service General Hospital

About this trial

This is a multi-center, retrospective study evaluating the performance of an artificial intelligence-enabled electrocardiography (AI-ECG) algorithm in detecting reduced left ventricular ejection fraction (LVEF ≤ 40%). All included patients from participating hospitals must have undergone a digital 12-lead electrocardiogram (ECG) and an echocardiogram with assessment of LVEF within seven days. The AI-ECG algorithm will be applied to evaluate its diagnostic performance, which will be further assessed across subgroups stratified by demographic characteristics and clinical factors.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

patients with ECGs and an echocardiogram within 7 days

Disqualifiers

Missing ECG signals

Missing LVEF assessment in echocardiograms

Trial population

All patients with ECGs and an echocardiogram within 7 days

Trial design

Design model

Cohort

Time perspective

Retrospective

Treatments tested in this trial

  • AI-ECG Algorithm

    Diagnostic test

    AI-ECG Algorithm to detect LVEF\<=40%

Treatment groups

No treatment groups listed

Trial outcomes

Primary outcomes

1

The Sensitivity and specificity of AI-ECG model for left ventricular ejection fraction ≤ 40%

The primary objective of the study was to evaluate the sensitivity and specificity of the artificial intelligence-enabled electrocardiography (AI-ECG) model in detecting left ventricular dysfunction, defined as left ventricular ejection fraction (LVEF) ≤ 40% as confirmed by transthoracic echocardiography.

Time frame
within 7 days

Secondary outcomes

Other outcomes

Sponsors and contacts

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