Healthy VolunteerT-ECGNCT07277374
Comparison of a Torso-Based Derived 6-Lead Electrocardiogram (ECG) Device With Standard 12-Lead Electrocardiogram (ECG) in Healthy Volunteers
An observational study of Healthy Volunteer, run by Haydarpasa Numune Training and Research Hospital at 1 site in Turkey (Türkiye).
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 90 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteer
- What is being tested?
- Torso-Based 6-Lead ECG Recording
- Type of treatment
- Medical device
- How many people
- 24 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 6 Dec 2023to 6 Jun 2024
- How long will I take part?
- 1 Day
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: 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.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Haydarpaşa Numune Training and Research Hospital - Emergency Medicine Department
Istanbul, 34668
About this study
Official title: Comparison of 6-Lead Electrocardiogram (ECG) Device Data With Standard 12-Lead Electrocardiogram (ECG) Data in Individuals With Different Anthropometric Characteristics
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.
Read the detailed description
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.
- Conditions
- Healthy Volunteer
- Being tested
- Torso-Based 6-Lead ECG Recording
- Keywords
- Electrocardiography, 6-lead ECG, 12-lead ECG, Torso ECG, ECG comparison
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Torso-Based 6-Lead ECG RecordingDevice
Non-invasive ECG measurement with torso electrode placement for comparison with standard 12-lead ECG.
| Study group | Role | What they receive |
|---|---|---|
| Healthy Volunteer ECG Group | Participants underwent standard 12-lead ECG and torso-based 6-lead ECG in a single session for comparative interval analysis. Receives: Device: Torso-Based 6-Lead ECG Recording |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
Measured: 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.
Measured: 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.
Measured: Single-session baseline ECG recording.
Secondary outcomes (1)
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)
Measured: Single-session recording (baseline only)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Dec 2025
- Study start6 Dec 2023
- Primary completion6 Mar 2024
- Study completion6 Jun 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy VolunteerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 24 participants (actual)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- Haydarpasa Numune Training and Research Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sinem Dogruyol, Haydarpasa Numune Training and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07277374
- Sponsor's protocol ID
- HNH-KAEK 2023/KK/193
- Acronym
- T-ECG
- Status last verified
- Dec 2025
- First submitted
- 26 Nov 2025
- Last updated
- 11 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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.
Study at a glance
From the registry record, last updated by the sponsor on 11 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of 6-Lead Electrocardiogram (ECG) Device Data With Standard 12-Lead Electrocardiogram (ECG) Data in Individuals With Different Anthropometric Characteristics
- ClinicalTrials.gov ID
- NCT07277374
- Acronym / sponsor ID
- T-ECG / HNH-KAEK 2023/KK/193
- Conditions
- Healthy Volunteer
- Keywords
- Electrocardiography, 6-lead ECG, 12-lead ECG, Torso ECG, ECG comparison
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Haydarpasa Numune Training and Research HospitalUniversity, hospital or other
- Study start
- 6 Dec 2023 (actual)
- Primary completion
- 6 Mar 2024 (actual)
- Study completion
- 6 Jun 2024 (actual)
- First posted
- 11 Dec 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Day
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Healthy Volunteer ECG Group | – | Device: Torso-Based 6-Lead ECG RecordingParticipants underwent standard 12-lead ECG and torso-based 6-lead ECG in a single session for comparative interval analysis. |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- 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.
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Torso-Based 6-Lead ECG RecordingNon-invasive ECG measurement with torso electrode placement for comparison with standard 12-lead ECG. | Device | Healthy Volunteer ECG Group |
Primary outcome
PR Interval Agreement Between Torso-Derived and Standard 12-Lead Electrocardiogram (ECG)
Time frame: Single-session baseline ECG recording.
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.
QRS Duration Agreement Between Torso-Derived and Standard 12-Lead Electrocardiogram (ECG)
Time frame: Single-session baseline ECG recording.
Mean difference in QRS duration between torso-derived six-lead ECG and standard 12-lead ECG recordings obtained during the same resting session
QT Interval Agreement Between Torso-Derived and Standard 12-Lead Electrocardiogram (ECG)
Time frame: Single-session baseline ECG recording
Mean difference in QT interval between torso-derived six-lead ECG and standard 12-lead ECG recordings obtained during the same resting session.
Heart Rate (HR) Agreement Between Torso-Derived and Standard 12-Lead Electrocardiogram (ECG)
Time frame: Single-session baseline ECG recording.
Mean difference in heart rate (HR) between torso-derived six-lead ECG and standard 12-lead ECG recordings obtained during the same resting session.
1 secondary outcome
Agreement Between Torso-Derived 6-Lead Electrocardiogram (ECG) and Standard 12-Lead Electrocardiogram (ECG) Measurements
Time frame: Single-session recording (baseline only)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Dec 2025.
- Individual participant dataSharing planned: 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Healthy Volunteer, run by Haydarpasa Numune Training and Research Hospital at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
PR Interval Agreement Between Torso-Derived and Standard 12-Lead Electrocardiogram (ECG) (time frame: Single-session baseline ECG recording.). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Dec 2025.