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AI-ECG Screening for Left Ventricular Systolic Dysfunction

AI-ECG Screening for Left Ventricular Systolic Dysfunction: A Prospective, Observational, Multicenter Study

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06231797
Enrollment
1530
Registered
2024-01-30
Start date
2024-02-01
Completion date
2025-07-10
Last updated
2024-02-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Left Ventricular Systolic Dysfunction

Brief summary

The purpose of the current study is to verify the effectiveness of the artificial intelligence algorithm applied to the electrocardiogram as a potential screening tool for left ventricular systolic dysfunction.

Detailed description

The current investigators have developed an artificial intelligence (AI) algorithm based on 12-lead electrocardiogram (ECG) detecting left ventricular systolic dysfunction, through 364,845 ECGs from 148,547 patients. Then, when the model was tested retrospectively on 59,805 ECGs of 24,376 patients, the model performance expressed as an area under the receiver operating characteristic curve was 0.889 (95% CI 0.887-0.891). The investigators are planning to prospectively validate the model's effectiveness as a potential screening tool for left ventricular systolic dysfunction.

Interventions

DIAGNOSTIC_TESTAI algorithm conducted on 12-lead ECG and transthoracic echocardiography

12-lead ECG is performed for each patient. For 12-lead ECG, AITIALVSD (AI algorithm) analysis will be performed through a separate server.

Sponsors

Seoul National University Hospital
Lead SponsorOTHER

Study design

Observational model
OTHER
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum

Inclusion criteria

* Individuals or those whose legal representative agree to participate in the study, and sign the consent form * Can complete both 12-lead electrocardiogram and transthoracic echocardiography

Exclusion criteria

* Individuals whose age is less than 18 year-old. * Individuals who do not agree to participate in the study * Patients who are unable to participate in clinical trials at the discretion of the investigator

Design outcomes

Primary

MeasureTime frameDescription
Area under the receiver operating characteristic curve (AUROC)Through study completion, an average of 1 yearAI model performance detecting LVSD, expressed as an AUROC. As a diagnostic assistance for LVSD, an ROC curve expressed as sensitivity to (1-specificity) will be presented, and the accuracy of prediction will be confirmed by calculating the AUROC, which is the area below.

Secondary

MeasureTime frameDescription
SensitivityThrough study completion, an average of 1 yearAI model sensitivity detecting LVSD
SpecificityThrough study completion, an average of 1 yearAI model sensitivity detecting patients with normal left ventricular systolic function
Positive predictive valueThrough study completion, an average of 1 yearPositive predictive value in the recruited patient population
Negative predictive valueThrough study completion, an average of 1 yearNegative predictive value in the recruited patient population

Contacts

Primary ContactHak Seung Lee, MD
cardiolee@gmail.com+1-771-216-0764

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026