Evaluation of the Accuracy of ECG Captured by CardioChip through Comparison of Lead I Recording to a Standard 12-Lead ECG Recording Device

Background: Remote cardiac rhythm monitoring and recording, using hand-carried electrocardiogram (ECG) device had been widely used in telemedicine. The feasibility and accuracy analysis on the data recorded by a new miniature ECG system-on-chip (SoC) system has not been explored before. Methods: This study evaluated the accuracy of the ECG recordings captured by CardioChip - a single-channeled, low-powered, miniature ECG SoC designed for mobile applications; comparing against Philips Pagewriter Trim III-a Food and Drug Administration certified, widely-used standard 12-lead ECG recording device, within Mackay Memorial Hospital in Taiwan. Results: Total of 111 participants, age ranging from 39 to 87years old [mean age: 61.2 ± 13.4, 57 male(51.3%) were enrolled. Two experienced cardiologists rated and scored the ECG morphology to be the same between the two devices, while CardioChip ECG was more sensitive to baseline noise. R-peak amplitudes measured both devices using single lead information (CardioChip ECG vs. Lead 1 in standard 12-lead ECG) showed statistical consistency. Offline analysis of signal correlation coefficients and coherence showed good correlation with both over 0.94 in average (0.94 ± 0.04 and 0.95 ± 0.04, respectively), high agreement between raters (94% agreement) for detecting abnormal cardiac rhythm with excellent R-peak amplitude (r = 0.98, p ＜ 0.001) and PR interval (r = 0.91, p ＜ 0.001) correlations, indicating excellent correlation between ECG recordings derived from two different modalities. Conclusions: The results suggested that CardioChip ECG is comparable to medical industry standard ECG. The future implementation of wearable ECG device embedded with miniature ECG system-on-chip (SoC) system is ready for clinical use, which will potentially enhance efficacy on identifying subjects with suspected cardiac arrhythmias.