AI-ECG Screening for Left Ventricular Systolic Dysfunction

February 1, 2024 updated by: Seoul National University Hospital

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

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Estimated)

1530

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

N/A

Sampling Method

Non-Probability Sample

Study Population

Patients undergoing 12-lead ECG and transthoracic echocardiography in routine clinical practice

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Area under the receiver operating characteristic curve (AUROC)
Time Frame: Through study completion, an average of 1 year
AI 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.
Through study completion, an average of 1 year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Sensitivity
Time Frame: Through study completion, an average of 1 year
AI model sensitivity detecting LVSD
Through study completion, an average of 1 year
Specificity
Time Frame: Through study completion, an average of 1 year
AI model sensitivity detecting patients with normal left ventricular systolic function
Through study completion, an average of 1 year
Positive predictive value
Time Frame: Through study completion, an average of 1 year
Positive predictive value in the recruited patient population
Through study completion, an average of 1 year
Negative predictive value
Time Frame: Through study completion, an average of 1 year
Negative predictive value in the recruited patient population
Through study completion, an average of 1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Seoul National University Hospital

Investigators

  • Principal Investigator: Seung-Pyo Lee, MD, PhD, Seoul National University Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

February 1, 2024

Primary Completion (Estimated)

July 10, 2024

Study Completion (Estimated)

July 10, 2025

Study Registration Dates

First Submitted

November 2, 2023

First Submitted That Met QC Criteria

January 21, 2024

First Posted (Actual)

January 30, 2024

Study Record Updates

Last Update Posted (Estimated)

February 5, 2024

Last Update Submitted That Met QC Criteria

February 1, 2024

Last Verified

October 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • H-2306-083-1439

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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