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Comparison of a Two-Lead, Computerized, Resting ECG Signal Analysis Device, the MultiFunction-CardioGramsm or MCG (a.k.a. 3DMP), to Quantitative Coronary Angiography for the Detection of Relevant Coronary Artery Stenosis (>70%) - A Meta-Analysis of all Published Trials Performed and Analyzed in the US

International Journal of Medical Sciences. 2009;6(4):143-155


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Journal Title: International Journal of Medical Sciences

ISSN: 1449-1907 (Online)

Publisher: Ivyspring International Publisher

LCC Subject Category: Medicine

Country of publisher: Australia

Language of fulltext: English

Full-text formats available: PDF, HTML



John E. Strobeck, Joseph T. Shen, Binoy Singh, Kotaro Obunai, Charles Miceli, Howard Sacher, Franz Ritucci, Michael Imhoff


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Time From Submission to Publication: 12 weeks


Abstract | Full Text

<p>Background: Accurate, non-invasive diagnosis of, and screening for, coronary artery disease (CAD) and restenosis after coronary revascularization has been a challenge due to either low sensitivity/specificity or relevant morbidity associated with current diagnostic modalities.</p> <p>Methods: To assess sensitivity and specificity of a new computerized, multiphase, resting electrocardiogram analysis device (MultiFunction-CardioGram<sup>sm</sup> or MCG a.k.a. 3DMP) for the detection of relevant coronary stenosis (&#62;70%), a meta-analysis of three published prospective trials performed in the US on patient data collected using the US manufactured device and analyzed using the US-based software and New York data analysis center from patients in the US, Germany, and Asia was completed. A total of 1076 patients from the three trials (US - 136; Germany - 751; Asia - 189) (average age 62 &#177; 11.5, 65 for women, 60 for men) scheduled for coronary angiography, were included in the analysis. Patients enrolled in the trials may or may not have had prior angiography and/or coronary intervention. Angiographic results in all studies were classified for hemodynamically relevant stenosis (&#62; 70%) by two US based angiographers independently.</p> <p>Results: Hemodynamically relevant stenosis was diagnosed in 467 patients (43.4%). The device, after performing a frequency-domain, computational analysis of the resting ECG leads and computer-database comparison, calculated a coronary ischemia &#8220;severity&#8221; score from 0 to 20 for each patient. The severity score was significantly higher for patients with relevant coronary stenosis (5.4 &#177; 1.8 vs. 1.7 &#177; 2.1). The study device (using a cut-off score for relevant stenosis of 4.0) correctly classified 941 of the 1076 patients with or without relevant stenosis (sensitivity-91.2%; specificity-84.6%; NPV 0.942, PPV 0.777). Adjusted positive and negative predictive values (PPV and NPV) were 81.9% and 92.6%, respectively (ROC AUC = 0.881 [95% CI: 0.860-0.903]). Subgroup analysis showed no significant influence of sex, age, race/nationality, previous revascularization procedures, resting ECG morphology, or participating center on the device's diagnostic performance.</p> <p>Conclusions: The new computerized, multiphase, resting ECG analysis device (MultiFunction-CardioGram<sup>sm</sup>) has been shown in this meta-analysis to safely and accurately identify patients with relevant coronary stenosis (&#62;70%) with high sensitivity and specificity and high negative predictive value. Its potential use in the evaluation of symptomatic patients suspected to suffer from coronary disease/ischemia is discussed.</p>