4-electrode ECG (DigitalCardio®) vs Standard 10-electrode ECG: Evaluating Ease of Use and Recording Quality (FAST-ECG)
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.
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Description détaillée
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.
Type d'étude
Inscription (Estimé)
Phase
- N'est pas applicable
Contacts et emplacements
Coordonnées de l'étude
- Nom: Bouchra BENKESSOU Chef de projet Recherche Clinique
- Numéro de téléphone: +33 7 64 48 60 16
- E-mail: b.benkessou@hexagone-sante-paris.fr
Lieux d'étude
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Paris, France, 75016
- Recrutement
- Bizet Clinic
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Contact:
- benkessou BOUCHRA
- Numéro de téléphone: 0764486016
- E-mail: b.benkessou@cliniques-bltparis.fr
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Paris, France, 75016
- Pas encore de recrutement
- Benkessou
-
Contact:
- benkessou BOUCHRA
- Numéro de téléphone: 0764486016
- E-mail: b.benkessou@hexagone-sante-paris.fr
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-
Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
- Adulte
- Adulte plus âgé
Accepte les volontaires sains
La description
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
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Soins de soutien
- Répartition: Randomisé
- Modèle interventionnel: Affectation croisée
- Masquage: Aucun (étiquette ouverte)
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
|
Autre: standard 10-electrode ECG
Undergoes standard 10-electrode ECG acquisition first
|
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.
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.
|
|
Comparateur actif: 4-electrode DigitalCardio
Undergoes 4-electrode DigitalCardio
|
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.
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.
|
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Comparison of Procedure Time Between 4-Electrode DigitalCardio® ECG and Standard 12-Lead ECG
Délai: 1 day
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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 |
1 day
|
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Comparative Quality Assessment of ECG Traces
Délai: 1 day
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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 |
1 day
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Intraclass Correlation Coefficient (ICC) for Quantitative ECG Parameters
Délai: 1 day
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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) |
1 day
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Diagnostic Concordance for Cardiac Pathology
Délai: 1 day
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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 |
1 day
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Healthcare Professional Satisfaction Score
Délai: 1 days
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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 |
1 days
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Incidence of Device-Related Technical Incidents for 4-electrode DigitalCardio® system
Délai: 1 day
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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 |
1 day
|
Collaborateurs et enquêteurs
Parrainer
Publications et liens utiles
Publications générales
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- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- Drew BJ, Ide B. Diagnosing ischemia from the bedside monitor. Prog Cardiovasc Nurs. 1996 Winter;11(1):45-6. No abstract available.
- 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.
- 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.
- 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.
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- Wagner GS, Macfarlane P, Wellens H, Josephson M, Gorgels A, Mirvis DM, Pahlm O, Surawicz B, Kligfield P, Childers R, Gettes LS, Bailey JJ, Deal BJ, Gorgels A, Hancock EW, Kors JA, Mason JW, Okin P, Rautaharju PM, van Herpen G; American Heart Association Electrocardiography and Arrhythmias Committee, Council on Clinical Cardiology; American College of Cardiology Foundation; Heart Rhythm Society. AHA/ACCF/HRS recommendations for the standardization and interpretation of the electrocardiogram: part VI: acute ischemia/infarction: a scientific statement from the American Heart Association Electrocardiography and Arrhythmias Committee, Council on Clinical Cardiology; the American College of Cardiology Foundation; and the Heart Rhythm Society. Endorsed by the International Society for Computerized Electrocardiology. J Am Coll Cardiol. 2009 Mar 17;53(11):1003-11. doi: 10.1016/j.jacc.2008.12.016. No abstract available.
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Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Réel)
Achèvement primaire (Estimé)
Achèvement de l'étude (Estimé)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Réel)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Mots clés
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- 2026-A00856-45
Informations sur les médicaments et les dispositifs, documents d'étude
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