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

Overview

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. 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.

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

1. 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. 2. 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. 3. Healthcare Professional Satisfaction:Participating healthcare professionals complete a structured questionnaire evaluating user satisfaction and usability of the CardioSecur® device in routine practice.

Interventions

• Device standard 10-electrode ECG acquisition
  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.
• Device 4-electrode DigitalCardio acquisition
  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.

Primary outcome measures

• Comparison of Procedure Time Between 4-Electrode DigitalCardio® ECG and Standard 12-Lead ECG [Time frame: 1 day]

Secondary outcome measures (5)

• 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]

Eligibility criteria

Inclusion criteria

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:

• 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

Exclusion criteria

• 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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation

Randomized

Model

Crossover

Masking

Open label

Primary purpose

Supportive care

Study locations

France · 2 centers

• Benkessou — Paris
• Bizet Clinic — Paris

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, H PMID 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 PMID 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 t PMID 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. PMID 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. PMID 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. PMID 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. PMID 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. PMID 1382387

Identifiers

NCT: NCT07732283 · 2026-A00856-45

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗