Health TrialsbyHealthPanel

AI-Based Cardiac Analysis Using 12-Lead and 1-Lead ECG

ConditionsHeart FailureAtrial Fibrillation (AF)Electrocardiogram
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age19+
SponsorInha University Hospital

About this trial

This pilot study is designed to evaluate the clinical performance and utility of the SmartECG-EF software in patients undergoing evaluations at Inha University Hospital. The primary objective is to assess how effectively the device assists clinicians in evaluating cardiac function and related clinical parameters. The study will prospectively enroll eligible participants to gather real-world clinical data, contributing to enhanced diagnostic accuracy and patient management.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Written informed consent provided voluntarily by the subject

Age ≥ 19 years

Patients who undergo standard 12-lead ECG measurement during the study period

Subjects with sinus rhythm on ECG at the time of examination

Disqualifiers

Subjects deemed inappropriate or unlikely to comply with the study requirements by the investigator

Patients with atrial fibrillation or atrial flutter on ECG at the time of examination

Patients with pacing rhythm due to a pacemaker

Subjects with severe tremor, uncooperativity, or skin conditions that make 1-lead ECG measurement difficult

Trial population

Patients visiting Inha University Hospital who undergo standard 12-lead and additional 1-lead ECG evaluations for cardiac assessment.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • SmartECG-EF

    Device

    The SmartECG-EF software is used to analyze 12-lead and 1-lead electrocardiogram (ECG) data to evaluate cardiac function, including left ventricular systolic dysfunction (LVSD), heart failure indicators, and related arrhythmic parameters.

Treatment groups

300 Participants
are divided into 1 treatment group
Group A: SmartECG-EF Evaluation Group1 intervention

Trial outcomes

Primary outcomes

1

Correlation and Agreement between 12-Lead and 1-Lead AI Scores

To evaluate the correlation (using Pearson or Spearman correlation coefficients), agreement (ICC using absolute agreement, two-way random model), and Bland-Altman analysis (mean difference and 95% limits of agreement) between 12-lead and 1-lead based AI scores.

Time frame
Day 1

Secondary outcomes

1

Area Under the ROC Curve (AUC-ROC) of AI scores

To assess the AUC-ROC of 1-lead and 12-lead based AI results against disease-specific reference standards, including heart failure, left ventricular systolic dysfunction (LVSD), and arrhythmic parameters.

Time frame
Baseline
2

Sensitivity and Specificity of AI scores

To assess sensitivity, specificity, positive predictive value (PPV), and negative predictive value (NPV) of 1-lead and 12-lead based AI results against disease-specific reference standards, including heart failure, left ventricular systolic dysfunction (LVSD), and arrhythmic parameters.

Time frame
baseline

Other outcomes

Sponsors and contacts

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

Inha University Hospital

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: