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

Обзор

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.

Подробное описание

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.

Вмешательства

• Устройство 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.
• Устройство 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.

Первичные конечные точки

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

Вторичные конечные точки (5)

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

Критерии участия

Критерии включения

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

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Рандомизированное

Модель

Перекрёстный дизайн

Маскирование

Открытое

Основная цель

Поддерживающая терапия

Центры проведения

Франция · 2 центра

• Benkessou — Paris
• Bizet Clinic — Paris

Публикации

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• 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
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• 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

Идентификаторы

NCT: NCT07732283 · 2026-A00856-45

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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