Validation of the detection of ischemia using 12 lead smartphone based electrocardiography - a non-randomized, single blinded, cross-sectional, multicenter study

Background: Reliable and early detection of myocardial ischemia using computer-aided analysis of electrocardiograms (ECG) provides an important reference for early diagnosis of CVD. We developed a 12-lead smartphone-based electrocardiogram (ECG) acquisition and monitoring system (called “Spandan”), and an application to assess underlying ischemia from analysis of electrocardiographic (ECG) signals only. Objectives of this study were to validate the Spandan 12 lead ECG interpretation for accuracy in the detection of Ischemia in comparison to cardiologists’ diagnosis and to evaluate the accuracy of ischemia in comparison to the interpretation of standard 12 lead ECG. Methods: In this multi-center study all patients (n=597) visiting the ECG room at the department of cardiology were enrolled in the study by taking their written consent and explaining the purpose of the study. Results: Mean age was 52.85 years. The male gender (n=344, 57.62%) shows the maximum frequency than female gender. 12 lead Spandan smartphone ECG recorded fewer false positive cases (8 versus 230) and identified greater true negative cases (310 versus 115). Spandan smartphone ECG recorded better specificity (97.4% versus 33.3%) and positive predictive value (87.4% versus 51.4%) as compared to gold standard ECG. The accuracy of interpretation of Ischemia by cardiologists diagnosis through 12 lead Spandan smartphone ECG was better (100%) as compared gold standard (95.3%). Conclusions: Our study highlights the potential of Spandan smartphone ECG in the detection of myocardial ischemia. This may improve patient satisfaction and reduce healthcare costs.