An observational study in Healthy Volunteer, sponsored by Haydarpasa Numune Training and Research Hospital. Completed at 1 site in Turkey (Türkiye). Open to participants aged 18 Years to 90 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-12-11.
Sponsored by Haydarpasa Numune Training and Research Hospital · Observational
This study aims to compare electrocardiographic interval measurements obtained from a torso-placed six-lead electrocardiogram (ECG) device (torso-derived ECG; T-ECG) with those obtained from a standard 12-lead electrocardiogram (ECG) in healthy adult volunteers. The torso-derived device synthesizes limb-lead signals using electrodes positioned on the thorax, potentially allowing for faster and more practical ECG acquisition in emergency department settings, operating rooms, and prehospital environments.
A total of 24 participants undergo both standard 12-lead ECG recording and torso-derived 6-lead ECG recording during the same study session. Heart rate (HR), PR interval, QRS duration, QT interval, and corrected QT (QTc) values are analyzed using Bland-Altman agreement analysis and correlation testing. The study also evaluates whether anthropometric characteristics-including body mass index (BMI)-influence the compatibility and agreement between the two measurement systems.
This observational, single-center clinical study evaluates the agreement between a torso-based derived six-lead electrocardiogram (ECG) system and a standard 12-lead electrocardiogram (ECG) in healthy adult volunteers. The study is conducted at Haydarpasa Numune Training and Research Hospital following ethics committee approval (Approval No: 2023/193). Volunteers aged 18 to 65 years without known cardiac disease are enrolled.
Each participant undergoes one standard 12-lead ECG recording followed by a torso-based six-lead ECG recording under identical resting conditions. Electrocardiographic measurements include heart rate (HR), RR interval, PR interval, QRS duration, QT interval, and corrected QT (QTc). Anthropometric characteristics-body weight, height, and body mass index (BMI)-are collected to assess whether body composition influences measurement consistency between the two systems.
Primary analysis includes Bland-Altman agreement statistics and correlation testing between ECG modalities. No drug administration, invasive procedure, randomization, or therapeutic intervention is applied. The study involves minimal risk and is limited to non-invasive surface ECG acquisition.
The expected clinical significance is that, if the torso-based ECG demonstrates measurement compatibility with the standard 12-lead ECG, simplified electrode placement may enable faster ECG acquisition in emergency departments, prehospital evaluations, and clinical scenarios in which limb lead placement is impractical.
Haydarpasa Numune Training and Research Hospital is the lead sponsor of 32 studies on the registry; 6 are open to participants now.
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The study population consists of healthy adult volunteers without known cardiovascular disease. All participants undergo both standard 12-lead electrocardiogram (ECG) recording and torso-derived 6-lead electrocardiogram (ECG) recording during a single study session. Participants are screened prior to inclusion to ensure the absence of baseline arrhythmia, ischemia, conduction delay, or structural heart disease.
Age between 18 and 65 years
No known cardiovascular disease
No arrhythmia, conduction disorder, or ischemic electrocardiogram (ECG) changes at baseline
Willingness to participate and ability to provide written informed consent
Exclusion Criteria:
Known cardiac disease, including coronary artery disease (CAD), arrhythmia, heart failure, or valvular heart disease
Pacemaker rhythm or baseline abnormal electrocardiogram (ECG) findings
Thoracic deformity or prior thoracic surgery that prevents appropriate electrode placement
Unwillingness to participate or inability to provide informed consent
Participants underwent standard 12-lead ECG and torso-based 6-lead ECG in a single session for comparative interval analysis.
Device: Torso-Based 6-Lead ECG Recording
Non-invasive ECG measurement with torso electrode placement for comparison with standard 12-lead ECG.
PR Interval Agreement Between Torso-Derived and Standard 12-Lead Electrocardiogram (ECG)
Mean difference in PR interval between torso-derived six-lead electrocardiogram (ECG) and standard 12-lead ECG recordings obtained during the same resting session. Single-session baseline ECG recording.
Time frame: Single-session baseline ECG recording.
QRS Duration Agreement Between Torso-Derived and Standard 12-Lead Electrocardiogram (ECG)
Mean difference in QRS duration between torso-derived six-lead ECG and standard 12-lead ECG recordings obtained during the same resting session
Time frame: Single-session baseline ECG recording.
QT Interval Agreement Between Torso-Derived and Standard 12-Lead Electrocardiogram (ECG)
Mean difference in QT interval between torso-derived six-lead ECG and standard 12-lead ECG recordings obtained during the same resting session.
Time frame: Single-session baseline ECG recording
Heart Rate (HR) Agreement Between Torso-Derived and Standard 12-Lead Electrocardiogram (ECG)
Mean difference in heart rate (HR) between torso-derived six-lead ECG and standard 12-lead ECG recordings obtained during the same resting session.
Time frame: Single-session baseline ECG recording.
Agreement Between Torso-Derived 6-Lead Electrocardiogram (ECG) and Standard 12-Lead Electrocardiogram (ECG) Measurements
Description: Comparison of PR interval, QRS duration, QT interval, and heart rate (HR) measurements obtained from torso-derived 6-lead electrocardiogram (ECG) recordings and standard 12-lead electrocardiogram (ECG) recordings to assess measurement concordance. Time Frame: Single-session recording (baseline only)
Time frame: Single-session recording (baseline only)
Plan to share: No — Individual participant data (IPD) will not be shared because the dataset includes only ECG recordings collected from healthy volunteers, and no identifiable patient-level information is stored or retained. Summary results may be shared in publication form, but raw individual-level data will not be publicly available.
No publications or documents are linked to this record.
This study is completed, as verified in Dec 2025. You cannot join it, but the record below documents what was studied.
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Haydarpasa Numune Training and Research Hospital