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Prospective Observational Cohort Study of Deep Learning-based ECG Algorithm for Detecting Left Ventricular Systolic Dysfunction

Status: Recruiting
Location: See location...
Intervention Type: Other
Study Type: Observational
SUMMARY

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
Participation Requirements
Sex: All
Minimum Age: 19
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
Republic of Korea
Ajou University School of Medicine
RECRUITING
Suwon
Contact Information
Primary
MOONSEUNG SOH, MD
mssoh7701@gmail.com
+82-31-219-5111
Time Frame
Start Date: 2026-01-01
Estimated Completion Date: 2027-12-31
Participants
Target number of participants: 1500
Treatments
Adults aged ≥19 years with ECG and echocardiography performed within 30 days
Adult patients aged 19 years or older who underwent both transthoracic echocardiography and electrocardiography (ECG) within 30 days of each other
Related Therapeutic Areas
Sponsors
Collaborators: VUNO Inc.
Leads: Ajou University School of Medicine

This content was sourced from clinicaltrials.gov

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