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

S. Mahajan, Salil Garg, Richa Sharma, Yogendra Pratap Singh, Nitin Chandola, T. Bhatia, Basundhara Bansal
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Abstract

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.  
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基于智能手机的12导联心电图检测缺血的验证——一项非随机、单盲、横断面、多中心研究
背景:利用计算机辅助心电图(ECG)可靠、早期检测心肌缺血,为CVD的早期诊断提供重要参考。我们开发了一种基于智能手机的12导联心电图采集和监测系统(称为“Spandan”),以及一种仅通过分析心电图信号来评估潜在缺血的应用程序。本研究的目的是验证Spandan 12导联心电图解释与心脏病专家诊断相比在检测缺血方面的准确性,并与标准12导联心电图解释相比评估缺血的准确性。方法:在这项多中心研究中,所有到访心内科心电室的患者(n=597)通过书面同意并解释研究目的加入研究。结果:平均年龄52.85岁。男性(n=344, 57.62%)出现频率高于女性。12导联Spandan智能手机心电图记录的假阳性病例较少(8例对230例),并确定了更多的真阴性病例(310例对115例)。与金标准心电图相比,Spandan智能手机心电图具有更好的特异性(97.4%对33.3%)和阳性预测值(87.4%对51.4%)。心脏病专家通过12导联Spandan智能手机心电图对缺血诊断的解释准确率(100%)优于金标准(95.3%)。结论:我们的研究强调了Spandan智能手机心电图在心肌缺血检测中的潜力。这可能会提高患者满意度并降低医疗成本。
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