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.
Studieoversikt
Status
Intervensjon / Behandling
Detaljert beskrivelse
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.
Studietype
Registrering (Antatt)
Kontakter og plasseringer
Studiekontakt
- Navn: Yongsoo Baek, M.D., Ph.D.
- Telefonnummer: +82-32-890-2200
- E-post: existsoo@inha.ac.kr
Studiesteder
-
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Incheon
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Incheon, Incheon, Sør -Korea, 22332
- Rekruttering
- Inha University Hospital
-
Ta kontakt med:
- Yongsoo Baek, M.D., Ph.D.
- Telefonnummer: +82-32-890-2200
- E-post: existsoo@inha.ac.kr
-
-
Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Prøvetakingsmetode
Studiepopulasjon
Patients visiting Inha University Hospital who undergo standard 12-lead and additional 1-lead ECG evaluations for cardiac assessment.
Beskrivelse
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)
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Observasjonsmodeller: COHORT
- Tidsperspektiver: PROSPECTIVE
Kohorter og intervensjoner
Gruppe / Kohort |
Intervensjon / Behandling |
|---|---|
|
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. |
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Correlation and Agreement between 12-Lead and 1-Lead AI Scores
Tidsramme: 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
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Area Under the ROC Curve (AUC-ROC) of AI scores
Tidsramme: Baseline
|
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
|
|
Sensitivity and Specificity of AI scores
Tidsramme: baseline
|
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
|
Samarbeidspartnere og etterforskere
Sponsor
Studierekorddatoer
Studer hoveddatoer
Studiestart (Antatt)
Primær fullføring (Antatt)
Studiet fullført (Antatt)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Faktiske)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- 2026-03-034-001
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
IPD-planbeskrivelse
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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