AI ECG Algorithm for Detecting LV Systolic Dysfunction

ConditionHF - Heart Failure

Trial statusRecruiting

Trial phaseNot listed

Trial typeObservational

Biological sexAll

Age19+

SponsorAjou University School of Medicine

About this trial

This prospective observational cohort study aims to evaluate the clinical performance of a deep learning-based electrocardiography (ECG) algorithm (DeepECG LVSD) for detecting left ventricular systolic dysfunction (LVSD), defined as left ventricular ejection fraction (LVEF) ≤40%, using transthoracic echocardiography as the reference standard. Approximately 15,000 adult patients undergoing both ECG and echocardiography within 30 days at Ajou University Hospital will be enrolled. Diagnostic performance will be assessed using the area under the receiver operating characteristic curve (AUROC), sensitivity, specificity, positive predictive value, negative predictive value, and accuracy. Secondary analyses will evaluate the association between AI-predicted LVSD and 30-day clinical outcomes, including all-cause mortality, emergency department visits, and heart failure rehospitalization.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Adults aged ≥19 years.

Patients who underwent both transthoracic echocardiography and 12-lead electrocardiography (ECG) at Ajou University Hospital in the outpatient, inpatient, or emergency department setting.

ECG and echocardiography performed within 30 days of each other.

Disqualifiers

Interval between ECG and echocardiography greater than 30 days.

Missing or corrupted original ECG waveform data (XML or HL7 format).

Presence of an implanted cardiac device, including a permanent pacemaker, implantable cardioverter-defibrillator (ICD), or cardiac resynchronization therapy (CRT) device.

Missing age, sex, or left ventricular ejection fraction (LVEF) data.

Trial population

Adult patients aged 19 years or older undergoing routine clinical care at Ajou University Hospital who have both transthoracic echocardiography and 12-lead electrocardiography (ECG) performed within 30 days. Participants may be recruited from outpatient clinics, inpatient wards, or the emergency department.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

None-placebo
Other intervention
There is no intervention group

Treatment groups

1,500 Participants

are divided into 1 treatment group

Group A: Adults aged ≥19 years with ECG and echocardiography performed within 30 days1 intervention

Trial outcomes

Primary outcomes

AUROC for detection of LVSD (LVEF ≤40%)

Diagnostic performance including AUROC, sensitivity, specificity, positive predictive value, negative predictive value, and accuracy.

Time frame

During procedure

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Ajou University School of Medicine

Lead sponsor

VUNO Inc.

Collaborator

Source ClinicalTrials.gov

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