4-electrode Tablet-based Electrocardiogram (ECG) SystemFAST-ECGNCT07732283

4-electrode ECG (DigitalCardio®) vs Standard 10-electrode ECG: Evaluating Ease of Use and Recording Quality

A study testing standard 10-electrode ECG acquisition and 4-electrode DigitalCardio acquisition in people with 4-electrode Tablet-based Electrocardiogram (ECG) System and Electrical Activity of the Heart, run by Clinique Bizet at 2 sites in France.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts

Official record

Search all trials

Trial summary

The goal of this clinical trial is to compare the time required to record a complete Electrocardiogram (ECG) trace using the DigitalCardio (CardioSecur®) tablet device versus a standard 12-lead ECG device in eligible patients. Read more about this study

Who is it for?: Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for: 4-electrode Tablet-based Electrocardiogram (ECG) System, Electrical Activity of the Heart, Atrial or Ventricular Arrhythmias
What is being tested?: standard 10-electrode ECG acquisition and 4-electrode DigitalCardio acquisition
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 50 participants
Where: 2 sitesFrance
Study dates: 4 Sep 2026to Mar 2027
Phase: Interventional
Are there results?: Not yet: the study is under way

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 years and older
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

Hospitalized Cardiology Patients:
Age minimum 18 years
Hospitalized for an acute or chronic cardiac condition (e.g., heart failure, acute coronary syndrome, arrhythmia, valvular heart disease, etc.)
Ability to give informed consent
Hemodynamic stability permitting the performance of an ECG without clinical risk
Cardiology Outpatients:

Show all 10Show fewer

Age minimum of 18 years
Follow-up for a known cardiac condition or suspected cardiovascular disease
No contraindications to performing an ECG
Informed consent obtained

Who cannot join

Minor patient (< 18 years of age)
Adult subject under legal protection, under temporary guardianship, curatorship, or tutelage
Patient refusing to participate in the study
Presence of an implantable cardiac device (e.g., pacemaker, defibrillator) that may interfere with ECG measurements
Severe skin condition preventing the placement of electrodes
Physical or cognitive inability to follow the study protocol
Current pregnancy

Trial locations and contacts

2 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Bouchra BENKESSOU Chef de projet Recherche Clinique contact

+33 7 64 48 60 16

b.benkessou@hexagone-sante-paris.fr

France2 sites, 2 recruiting

Benkessou
Paris, 75016
benkessou BOUCHRA, 0764486016, b.benkessou@hexagone-sante-paris.fr
Not yet recruiting
Bizet Clinic
Paris, 75016
benkessou BOUCHRA, 0764486016, b.benkessou@cliniques-bltparis.fr
Recruiting

Other trials in France

About this study

The main questions it aims to answer are:

Is there a difference in diagnostic recording time (in minutes) between the DigitalCardio tablet and a standard ECG machine? How do the two devices compare in terms of trace quality (including QRS duration, QT interval, frontal axis measurements, and missing/erroneous leads)? How satisfied are healthcare professionals with the CardioSecur® device?

Researchers will compare Group A (standard 10-electrode ECG followed by 4-electrode ECG) to Group B (4-electrode ECG followed by standard 10-electrode ECG) in a 1:1 randomized crossover design to evaluate recording efficiency and trace quality.

Participants will:

Complete an initial screening visit with the principal investigator to review eligibility criteria and sign the informed consent form.

Be randomly assigned (1:1 ratio) to either Group A or Group B. Undergo both ECG recording methods sequentially (a standard 10-electrode ECG and a 4-electrode ECG using the DigitalCardio tablet), while researchers measure the total time elapsed from electrode placement to obtaining a complete trace.

Read the detailed description

This study is a randomized, crossover clinical trial designed to compare the efficiency, trace quality, and user satisfaction of a novel 4-electrode tablet-based Electrocardiogram (ECG) system (DigitalCardio / CardioSecur®) against a standard 12-lead (10-electrode) ECG device.

Background and Rationale

An electrocardiogram (ECG) is a fundamental diagnostic tool used to record the electrical activity of the heart. Conventional 12-lead ECGs require placing 10 individual electrodes on a patient's limbs and chest while the patient is lying down. While highly detailed, electrode placement and device setup can be time-consuming in clinical workflows. The DigitalCardio tablet system utilizes a simplified 4-electrode setup designed to streamline data acquisition without compromising diagnostic accuracy.

Study Design and Procedures

After an initial screening process led by the principal investigator, eligible participants receive detailed study information and provide written informed consent. Enrolled participants are then randomly assigned in a 1:1 ratio to one of two sequence groups to control for order effects:

*Group A:Undergoes standard 10-electrode ECG acquisition first, followed immediately by 4-electrode DigitalCardio acquisition.

Group B: Undergoes 4-electrode DigitalCardio acquisition first, followed immediately by standard 10-electrode ECG acquisition.

To maintain consistency, both ECG recordings for a given participant are performed by the same healthcare operator within a minimal time interval.

Key Measurements

Diagnostic Time:Research staff record the exact time elapsed (in minutes) from the initiation of electrode placement to the successful capture of a complete ECG trace for both devices.
Trace Quality and Concordance:Printed and anonymized ECG traces are submitted to independent evaluators. Evaluators independently assess trace quality based on standardized criteria, comparing automated measurements (frontal axis, median QRS duration, and QT interval) and counting any missing or erroneous leads.
Healthcare Professional Satisfaction:Participating healthcare professionals complete a structured questionnaire evaluating user satisfaction and usability of the CardioSecur® device in routine practice.

Conditions: 4-electrode Tablet-based Electrocardiogram (ECG) System, Electrical Activity of the Heart, Atrial or Ventricular Arrhythmias, Intracardiac Conduction Abnormalities, QT Interval Prolongation, Myocardial Ischemia
Being tested: standard 10-electrode ECG acquisition, 4-electrode DigitalCardio acquisition
Keywords: 4-electrode tablet-based Electrocardiogram (ECG) system, standard 12-lead (10-electrode) ECG device
Medical subject headings: Myocardial Ischemia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

standard 10-electrode ECG acquisitionDevice
Patient undergoes standard 10-electrode ECG acquisition. Then anonymized ECG traces is printed are submitted to independent evaluators. Evaluators independently assess trace quality based on standardized criteria, comparing automated measurements (frontal axis, median QRS duration, and QT interval) and counting any missing or erroneous leads. Followed immediately by 4-electrode DigitalCardio acquisition.
4-electrode DigitalCardio acquisitionDevice
Patient undergoes 4-electrode DigitalCardio acquisition acquisition. Then anonymized ECG traces is printed are submitted to independent evaluators. Evaluators independently assess trace quality based on standardized criteria, comparing automated measurements (frontal axis, median QRS duration, and QT interval) and counting any missing or erroneous leads. Followed immediately by standard 10-electrode ECG acquisition.

Study groups in NCT07732283
Study group	Role	What they receive
standard 10-electrode ECG	Other	Undergoes standard 10-electrode ECG acquisition first Receives: Device: standard 10-electrode ECG acquisition; Device: 4-electrode DigitalCardio acquisition
4-electrode DigitalCardio	Active comparator	Undergoes 4-electrode DigitalCardio Receives: Device: standard 10-electrode ECG acquisition; Device: 4-electrode DigitalCardio acquisition

What is being measured

The primary outcome is the main question the study is designed to answer.

Comparison of Procedure Time Between 4-Electrode DigitalCardio® ECG and Standard 12-Lead ECG
Time elapsed from the initiation of electrode placement to the obtaining of a complete ECG trace for both the 4-electrode DigitalCardio® system and the standard 12-lead ECG device.
Unit of Measure: Minutes
Measured: 1 day

Secondary outcomes (5)

Comparative Quality Assessment of ECG Traces
Proportion of paired recordings in which an independent cardiologist prefers the 4-electrode DigitalCardio® trace compared to the standard 12-lead ECG trace, based on visual evaluation of signal clarity and the presence of artifacts/interference.
Unit of Measure: Percentage of paired recordings
Measured: 1 day
Intraclass Correlation Coefficient (ICC) for Quantitative ECG Parameters
Degree of agreement for quantitative clinical parameters (e.g., QRS duration, QT interval, frontal axis measurements) automatically provided by both the 4-electrode DigitalCardio® system and the standard 12-lead ECG device.
Unit of Measure: Intraclass Correlation Coefficient (ICC) (ranging from 0 to 1, where higher values indicate better agreement)
Measured: 1 day
Diagnostic Concordance for Cardiac Pathology
Agreement in detecting the presence or absence of cardiac pathology using the 4-electrode DigitalCardio® system compared to the standard 12-lead ECG (gold standard).
Unit of Measure: Percentage of concordant diagnostic evaluations
Measured: 1 day
Healthcare Professional Satisfaction Score
Overall user satisfaction regarding the ease of use of the DigitalCardio® tablet device, evaluated by participating healthcare professionals using a structured Likert scale. The score ranges from 1 (strongly disagree / highly unsatisfied) to 5 (strongly agree / highly satisfied), where higher scores indicate a better outcome (higher satisfaction).
Unit of Measure: Score on a scale
Measured: 1 days
Incidence of Device-Related Technical Incidents for 4-electrode DigitalCardio® system
Total number of technical malfunctions, failures, or operational incidents reported for 4-electrode DigitalCardio® system devices during procedures. And how the issu is been managed.
Unit of Measure: Number of technical incidents
Measured: 1 day

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

4 Sep 2026Mar 2027

First posted28 Jul 2026
Study start4 Sep 2026
Primary completionDec 2026 (estimated)
Study completionMar 2027 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (24)Papers the sponsor has linked to this study.
Other trials for 4-electrode Tablet-based Electrocardiogram (ECG) SystemStudies 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: Interventional
Phase: Phase N/A
Primary purpose: Supportive care
Allocation: Randomised
Intervention model: Crossover
Masking: None (open label)
Enrolment: 50 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT07732283
Sponsor's protocol ID: 2026-A00856-45
Acronym: FAST-ECG
Status last verified: Jul 2026
First submitted: 23 Jul 2026
Last updated: 11 Sep 2026
Results posted: No
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No

Publications

Thygesen K, Alpert JS, Jaffe AS, Simoons ML, Chaitman BR, White HD; Writing Group on the Joint ESC/ACCF/AHA/WHF Task Force for the Universal Definition of Myocardial Infarction; Thygesen K, Alpert JS, White HD, Jaffe AS, Katus HA, Apple FS, Lindahl B, Morrow DA, Chaitman BA, Clemmensen PM, Johanson P, Hod H, Underwood R, Bax JJ, Bonow RO, Pinto F, Gibbons RJ, Fox KA, Atar D, Newby LK, Galvani M, Hamm CW, Uretsky BF, Steg PG, Wijns W, Bassand JP, Menasche P, Ravkilde J, Ohman EM, Antman EM, Wallentin LC, Armstrong PW, Simoons ML, Januzzi JL, Nieminen MS, Gheorghiade M, Filippatos G, Luepker RV, Fortmann SP, Rosamond WD, Levy D, Wood D, Smith SC, Hu D, Lopez-Sendon JL, Robertson RM, Weaver D, Tendera M, Bove AA, Parkhomenko AN, Vasilieva EJ, Mendis S; ESC Committee for Practice Guidelines (CPG). Third universal definition of myocardial infarction. Eur Heart J. 2012 Oct;33(20):2551-67. doi: 10.1093/eurheartj/ehs184. Epub 2012 Aug 24. No abstract available.
PubMed 22922414
Roffi M, Patrono C, Collet JP, Mueller C, Valgimigli M, Andreotti F, Bax JJ, Borger MA, Brotons C, Chew DP, Gencer B, Hasenfuss G, Kjeldsen K, Lancellotti P, Landmesser U, Mehilli J, Mukherjee D, Storey RF, Windecker S; ESC Scientific Document Group. 2015 ESC Guidelines for the management of acute coronary syndromes in patients presenting without persistent ST-segment elevation: Task Force for the Management of Acute Coronary Syndromes in Patients Presenting without Persistent ST-Segment Elevation of the European Society of Cardiology (ESC). Eur Heart J. 2016 Jan 14;37(3):267-315. doi: 10.1093/eurheartj/ehv320. Epub 2015 Aug 29. No abstract available.
PubMed 26320110
Ibanez B, James S, Agewall S, Antunes MJ, Bucciarelli-Ducci C, Bueno H, Caforio ALP, Crea F, Goudevenos JA, Halvorsen S, Hindricks G, Kastrati A, Lenzen MJ, Prescott E, Roffi M, Valgimigli M, Varenhorst C, Vranckx P, Widimsky P; ESC Scientific Document Group. 2017 ESC Guidelines for the management of acute myocardial infarction in patients presenting with ST-segment elevation: The Task Force for the management of acute myocardial infarction in patients presenting with ST-segment elevation of the European Society of Cardiology (ESC). Eur Heart J. 2018 Jan 7;39(2):119-177. doi: 10.1093/eurheartj/ehx393. No abstract available.
PubMed 28886621
Nelwan SP, Kors JA, Crater SW, Meij SH, van Dam TB, Simoons ML, Krucoff MW. Simultaneous comparison of 3 derived 12-lead electrocardiograms with standard electrocardiogram at rest and during percutaneous coronary occlusion. J Electrocardiol. 2008 May-Jun;41(3):230-7. doi: 10.1016/j.jelectrocard.2008.01.011.
PubMed 18433614
Welinder AE, Wagner GS, Horacek BM, Martin TN, Maynard C, Pahlm O. EASI-Derived vs standard 12-lead electrocardiogram for Selvester QRS score estimations of chronic myocardial infarct size, using cardiac magnetic resonance imaging as gold standard. J Electrocardiol. 2009 Mar-Apr;42(2):145-51. doi: 10.1016/j.jelectrocard.2008.10.010. Epub 2008 Dec 18.
PubMed 19100565
Horacek BM, Warren JW, Penney CJ, MacLeod RS, Title LM, Gardner MJ, Feldman CL. Optimal electrocardiographic leads for detecting acute myocardial ischemia. J Electrocardiol. 2001;34 Suppl:97-111. doi: 10.1054/jelc.2001.28844.
PubMed 11781943
Martinez JP, Laguna P, Olmos S, Pahlm O, Pettersson J, Sornmo L. Assessment of QT-measurement accuracy using the 12-lead electrocardiogram derived from EASI leads. J Electrocardiol. 2007 Apr;40(2):172-9. doi: 10.1016/j.jelectrocard.2006.08.089. Epub 2006 Oct 6.
PubMed 17027840
Denes P. The importance of derived 12-lead electrocardiography in the interpretation of arrhythmias detected by Holter recording. Am Heart J. 1992 Oct;124(4):905-11. doi: 10.1016/0002-8703(92)90971-w.
PubMed 1382387
Drew BJ, Koops RR, Adams MG, Dower GE. Derived 12-lead ECG. Comparison with the standard ECG during myocardial ischemia and its potential application for continuous ST-segment monitoring. J Electrocardiol. 1994;27 Suppl:249-55. doi: 10.1016/s0022-0736(94)80100-2. No abstract available.
PubMed 7884370
Drew BJ, Ide B. Diagnosing ischemia from the bedside monitor. Prog Cardiovasc Nurs. 1996 Winter;11(1):45-6. No abstract available.
PubMed 8657711
Schächinger, Volker, Bartosz Przybyla, Pilotstudie zur Detektion von Myokardischämie mit einer auf EASI Standard basierten 3D-Vektor-Eketrokardiographie (CardioSecur), Klinikum Fulda, unpublished
Okada, Kozo, Comparison of App-based 22-lead electrocardiogram with standard 12-lead electrocardiogram for the diagnosis of acute coronary syndromes, Yokohama City University Medical Center, unpublished
Johnson H, Duarte N, Ryding D, Perry D, McNally S, Stuart AG, Williams CA, Pieles G. Assessment of a Novel, 22-lead Mobile Electrocardiogram in Elite, Adolescent Footballers. Int J Sports Med. 2022 Mar;43(3):245-253. doi: 10.1055/a-1537-9757. Epub 2021 Aug 13.
PubMed 34388845
Spaich S, Kern H, Zelniker TA, Stiepak J, Gabel M, Popp E, Katus HA, Preusch MR. Feasibility of CardioSecur(R), a Mobile 4-Electrode/22-Lead ECG Device, in the Prehospital Emergency Setting. Front Cardiovasc Med. 2020 Oct 9;7:551796. doi: 10.3389/fcvm.2020.551796. eCollection 2020.
PubMed 33195450
De Bie J, Martignani C, Massaro G, Diemberger I. Performance of seven ECG interpretation programs in identifying arrhythmia and acute cardiovascular syndrome. J Electrocardiol. 2020 Jan-Feb;58:143-149. doi: 10.1016/j.jelectrocard.2019.11.043. Epub 2019 Nov 30.
PubMed 31884310

Study at a glance

From the registry record, last updated by the sponsor on 11 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: 4-electrode ECG (DigitalCardio®) vs Standard 10-electrode ECG: Evaluating Ease of Use and Recording Quality
ClinicalTrials.gov ID: NCT07732283
Acronym / sponsor ID: FAST-ECG / 2026-A00856-45
Conditions: 4-electrode Tablet-based Electrocardiogram (ECG) System, Electrical Activity of the Heart, Atrial or Ventricular Arrhythmias, Intracardiac Conduction Abnormalities, QT Interval Prolongation, Myocardial Ischemia
Keywords: 4-electrode tablet-based Electrocardiogram (ECG) system, standard 12-lead (10-electrode) ECG device
Study type: Interventional
Recruitment status: Recruiting
Enrolment: 50 participants (estimated)
Lead sponsor: Clinique BizetUniversity, hospital or other
Study start: 4 Sep 2026 (actual)
Primary completion: Dec 2026 (estimated)
Study completion: Mar 2027 (estimated)
First posted: 28 Jul 2026 (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.

The main questions it aims to answer are:

Participants will:

Complete an initial screening visit with the principal investigator to review eligibility criteria and sign the informed consent form.

Detailed description

Background and Rationale

Study Design and Procedures

*Group A:Undergoes standard 10-electrode ECG acquisition first, followed immediately by 4-electrode DigitalCardio acquisition.

Group B: Undergoes 4-electrode DigitalCardio acquisition first, followed immediately by standard 10-electrode ECG acquisition.

To maintain consistency, both ECG recordings for a given participant are performed by the same healthcare operator within a minimal time interval.

Key Measurements

Diagnostic Time:Research staff record the exact time elapsed (in minutes) from the initiation of electrode placement to the successful capture of a complete ECG trace for both devices.
Trace Quality and Concordance:Printed and anonymized ECG traces are submitted to independent evaluators. Evaluators independently assess trace quality based on standardized criteria, comparing automated measurements (frontal axis, median QRS duration, and QT interval) and counting any missing or erroneous leads.
Healthcare Professional Satisfaction:Participating healthcare professionals complete a structured questionnaire evaluating user satisfaction and usability of the CardioSecur® device in routine practice.

Study design

Primary purpose: Supportive care
Allocation: Randomised
Intervention model: Crossover
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
standard 10-electrode ECG	Other	Device: standard 10-electrode ECG acquisition, Device: 4-electrode DigitalCardio acquisitionUndergoes standard 10-electrode ECG acquisition first
4-electrode DigitalCardio	Active comparator	Device: standard 10-electrode ECG acquisition, Device: 4-electrode DigitalCardio acquisitionUndergoes 4-electrode DigitalCardio

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (10 listed)

Age minimum 18 years
Hospitalized for an acute or chronic cardiac condition (e.g., heart failure, acute coronary syndrome, arrhythmia, valvular heart disease, etc.)
Ability to give informed consent
Hemodynamic stability permitting the performance of an ECG without clinical risk
Age minimum of 18 years

Key exclusion criteria (7 listed)

Minor patient (< 18 years of age)
Adult subject under legal protection, under temporary guardianship, curatorship, or tutelage
Patient refusing to participate in the study
Presence of an implantable cardiac device (e.g., pacemaker, defibrillator) that may interfere with ECG measurements
Severe skin condition preventing the placement of electrodes

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
standard 10-electrode ECG acquisitionPatient undergoes standard 10-electrode ECG acquisition. Then anonymized ECG traces is printed are submitted to independent evaluators. Evaluators independently assess trace quality based on standardized criteria, comparing automated measurements (frontal axis, median QRS duration, and QT interval) and counting any missing or erroneous leads. Followed immediately by 4-electrode DigitalCardio acquisition.	Device	4-electrode DigitalCardio, standard 10-electrode ECG
4-electrode DigitalCardio acquisitionPatient undergoes 4-electrode DigitalCardio acquisition acquisition. Then anonymized ECG traces is printed are submitted to independent evaluators. Evaluators independently assess trace quality based on standardized criteria, comparing automated measurements (frontal axis, median QRS duration, and QT interval) and counting any missing or erroneous leads. Followed immediately by standard 10-electrode ECG acquisition.	Device	4-electrode DigitalCardio, standard 10-electrode ECG

Primary outcome

Comparison of Procedure Time Between 4-Electrode DigitalCardio® ECG and Standard 12-Lead ECG
Time frame: 1 day
Time elapsed from the initiation of electrode placement to the obtaining of a complete ECG trace for both the 4-electrode DigitalCardio® system and the standard 12-lead ECG device. Unit of Measure: Minutes

5 secondary outcomes

Comparative Quality Assessment of ECG Traces
Time frame: 1 day
Intraclass Correlation Coefficient (ICC) for Quantitative ECG Parameters
Time frame: 1 day
Diagnostic Concordance for Cardiac Pathology
Time frame: 1 day
Healthcare Professional Satisfaction Score
Time frame: 1 days
Incidence of Device-Related Technical Incidents for 4-electrode DigitalCardio® system
Time frame: 1 day

Results and safety

This study is still under way. Results are not available in the source record yet.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 11 Sep 2026.
Background: PubMed 22922414Thygesen K, Alpert JS, Jaffe AS, Simoons ML, Chaitman BR, White HD; Writing Group on the Joint ESC/ACCF/AHA/WHF Task Force for the Universal Definition of Myocardial Infarction; Thygesen K, Alpert JS, White HD, Jaffe AS, Katus HA, Apple FS, Lindahl B, Morrow DA, Chaitman BA, Clemmensen PM, Johanson P, Hod H, Underwood R, Bax JJ, Bonow RO, Pinto F, Gibbons RJ, Fox KA, Atar D, Newby LK, Galvani M, Hamm CW, Uretsky BF, Steg PG, Wijns W, Bassand JP, Menasche P, Ravkilde J, Ohman EM, Antman EM, Wallentin LC, Armstrong PW, Simoons ML, Januzzi JL, Nieminen MS, Gheorghiade M, Filippatos G, Luepker RV, Fortmann SP, Rosamond WD, Levy D, Wood D, Smith SC, Hu D, Lopez-Sendon JL, Robertson RM, Weaver D, Tendera M, Bove AA, Parkhomenko AN, Vasilieva EJ, Mendis S; ESC Committee for Practice Guidelines (CPG). Third universal definition of myocardial infarction. Eur Heart J. 2012 Oct;33(20):2551-67. doi: 10.1093/eurheartj/ehs184. Epub 2012 Aug 24. No abstract available.
Background: PubMed 26320110Roffi M, Patrono C, Collet JP, Mueller C, Valgimigli M, Andreotti F, Bax JJ, Borger MA, Brotons C, Chew DP, Gencer B, Hasenfuss G, Kjeldsen K, Lancellotti P, Landmesser U, Mehilli J, Mukherjee D, Storey RF, Windecker S; ESC Scientific Document Group. 2015 ESC Guidelines for the management of acute coronary syndromes in patients presenting without persistent ST-segment elevation: Task Force for the Management of Acute Coronary Syndromes in Patients Presenting without Persistent ST-Segment Elevation of the European Society of Cardiology (ESC). Eur Heart J. 2016 Jan 14;37(3):267-315. doi: 10.1093/eurheartj/ehv320. Epub 2015 Aug 29. No abstract available.
Background: PubMed 28886621Ibanez B, James S, Agewall S, Antunes MJ, Bucciarelli-Ducci C, Bueno H, Caforio ALP, Crea F, Goudevenos JA, Halvorsen S, Hindricks G, Kastrati A, Lenzen MJ, Prescott E, Roffi M, Valgimigli M, Varenhorst C, Vranckx P, Widimsky P; ESC Scientific Document Group. 2017 ESC Guidelines for the management of acute myocardial infarction in patients presenting with ST-segment elevation: The Task Force for the management of acute myocardial infarction in patients presenting with ST-segment elevation of the European Society of Cardiology (ESC). Eur Heart J. 2018 Jan 7;39(2):119-177. doi: 10.1093/eurheartj/ehx393. No abstract available.
Background: PubMed 18433614Nelwan SP, Kors JA, Crater SW, Meij SH, van Dam TB, Simoons ML, Krucoff MW. Simultaneous comparison of 3 derived 12-lead electrocardiograms with standard electrocardiogram at rest and during percutaneous coronary occlusion. J Electrocardiol. 2008 May-Jun;41(3):230-7. doi: 10.1016/j.jelectrocard.2008.01.011.
Background: PubMed 19100565Welinder AE, Wagner GS, Horacek BM, Martin TN, Maynard C, Pahlm O. EASI-Derived vs standard 12-lead electrocardiogram for Selvester QRS score estimations of chronic myocardial infarct size, using cardiac magnetic resonance imaging as gold standard. J Electrocardiol. 2009 Mar-Apr;42(2):145-51. doi: 10.1016/j.jelectrocard.2008.10.010. Epub 2008 Dec 18.
Background: PubMed 11781943Horacek BM, Warren JW, Penney CJ, MacLeod RS, Title LM, Gardner MJ, Feldman CL. Optimal electrocardiographic leads for detecting acute myocardial ischemia. J Electrocardiol. 2001;34 Suppl:97-111. doi: 10.1054/jelc.2001.28844.
Background: PubMed 17027840Martinez JP, Laguna P, Olmos S, Pahlm O, Pettersson J, Sornmo L. Assessment of QT-measurement accuracy using the 12-lead electrocardiogram derived from EASI leads. J Electrocardiol. 2007 Apr;40(2):172-9. doi: 10.1016/j.jelectrocard.2006.08.089. Epub 2006 Oct 6.
Background: PubMed 1382387Denes P. The importance of derived 12-lead electrocardiography in the interpretation of arrhythmias detected by Holter recording. Am Heart J. 1992 Oct;124(4):905-11. doi: 10.1016/0002-8703(92)90971-w.
Background: PubMed 7884370Drew BJ, Koops RR, Adams MG, Dower GE. Derived 12-lead ECG. Comparison with the standard ECG during myocardial ischemia and its potential application for continuous ST-segment monitoring. J Electrocardiol. 1994;27 Suppl:249-55. doi: 10.1016/s0022-0736(94)80100-2. No abstract available.
Background: PubMed 8657711Drew BJ, Ide B. Diagnosing ischemia from the bedside monitor. Prog Cardiovasc Nurs. 1996 Winter;11(1):45-6. No abstract available.
BackgroundSchächinger, Volker, Bartosz Przybyla, Pilotstudie zur Detektion von Myokardischämie mit einer auf EASI Standard basierten 3D-Vektor-Eketrokardiographie (CardioSecur), Klinikum Fulda, unpublished
BackgroundOkada, Kozo, Comparison of App-based 22-lead electrocardiogram with standard 12-lead electrocardiogram for the diagnosis of acute coronary syndromes, Yokohama City University Medical Center, unpublished

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.

Bouchra BENKESSOU Chef de projet Recherche Clinique contact

+33 7 64 48 60 16

b.benkessou@hexagone-sante-paris.fr

2 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

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 10 inclusion and 7 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: looking for participants now, as of the sponsor's last update on 11 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in France. 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?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Bouchra BENKESSOU Chef de projet Recherche Clinique (+33 7 64 48 60 16, b.benkessou@hexagone-sante-paris.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Comparison of Procedure Time Between 4-Electrode DigitalCardio® ECG and Standard 12-Lead ECG (time frame: 1 day). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07732283, which also lists 24 linked publications.

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 Sep 2026.