AI-Based Cardiac Analysis Using 12-Lead and 1-Lead ECG
Prospective Observational Comparative Pilot Study to Evaluate Performance of an AI-based Cardiac Disease Analysis Algorithm Using Standard 12-lead ECG and Single-lead ECG Data
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.
Panoramica dello studio
Stato
Intervento / Trattamento
Descrizione dettagliata
This is a prospective, single-center pilot study conducted at Inha University Hospital to evaluate the clinical performance and feasibility of the SmartECG-EF software. Eligible participants will undergo standard clinical evaluations alongside the investigational device assessment. The study aims to investigate the diagnostic utility and operational workflow of integrating the software into routine clinical practice. Data regarding clinical parameters, primary and secondary outcome measures, and any device-related adverse events will be systematically collected and analyzed to assess safety and efficacy.
Tipo di studio
Iscrizione (Stimato)
Contatti e Sedi
Contatto studio
- Nome: Yongsoo Baek, M.D., Ph.D.
- Numero di telefono: +82-32-890-2200
- Email: existsoo@inha.ac.kr
Luoghi di studio
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Incheon
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Incheon, Incheon, Corea del Sud, 22332
- Reclutamento
- Inha University Hospital
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Contatto:
- Yongsoo Baek, M.D., Ph.D.
- Numero di telefono: +82-32-890-2200
- Email: existsoo@inha.ac.kr
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-
Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
Accetta volontari sani
Sessi ammissibili allo studio
Metodo di campionamento
Popolazione di studio
Patients visiting Inha University Hospital who undergo standard 12-lead and additional 1-lead ECG evaluations for cardiac assessment.
Descrizione
Inclusion Criteria:
- 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
- Subjects available for additional 1-lead ECG measurement during the same visit
Exclusion Criteria:
- 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
- Subjects whose additional study measurements would delay standard medical care due to a critical medical condition
- Withdrawal of consent or refusal to agree to personal information usage
- ECG with sub-standard quality (unanalyzable noise, lead disconnection, etc.; note: unanalyzable rate evaluation can be recorded separately)
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Modelli osservazionali: COHORT
- Prospettive temporali: PROSPECTIVE
Coorti e interventi
Gruppo / Coorte |
Intervento / Trattamento |
|---|---|
|
SmartECG-EF Evaluation Group
Patients undergoing prospective evaluation using the SmartECG-EF software for cardiac function assessment and ECG-based parameter analysis at Inha University Hospital. |
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. |
Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Correlation and Agreement between 12-Lead and 1-Lead AI Scores
Lasso di tempo: Day 1
|
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. |
Day 1
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Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Area Under the ROC Curve (AUC-ROC) of AI scores
Lasso di tempo: Baseline
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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. |
Baseline
|
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Sensitivity and Specificity of AI scores
Lasso di tempo: baseline
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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. |
baseline
|
Collaboratori e investigatori
Sponsor
Studiare le date dei record
Studia le date principali
Inizio studio (Stimato)
Completamento primario (Stimato)
Completamento dello studio (Stimato)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Effettivo)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- 2026-03-034-001
Piano per i dati dei singoli partecipanti (IPD)
Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?
Descrizione del piano IPD
A specific plan for sharing individual participant data has not yet been finalized as this is a pilot study. Data sharing will be evaluated upon reasonable request and in accordance with institutional guidelines and IRB approvals.
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