As of 2010 Coronary Artery Disease, remains the number 1 cause of death for people of all ages in the United States. 1 in 3 women will die from coronary artery disease, yet research and diagnostic techniques have traditionally focused on men, leading to a significant gender gap in knowledge and diagnostic accuracy. Premier heart’s Multifunction Cardiogram (MCG) technology represents the best available noninvasive, stress, radiation and drug free approach to detecting CAD ischemia without any gender bias. MCG has been validated in multiple prospective clinical trial comparing MCG results to the invasive coronary angiography as the gold standard for CAD diagnosis for the ability to detect and quantify ischemia resulting from CAD earlier, cheaper with the highest accuracy available.

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.Methods: To assess sensitivity and specificity of a new computerized, multiphase, resting electrocardiogram analysis device (MultiFunction-CardioGram(sm) or MCG a.k.a. 3DMP) for the detection of relevant coronary stenosis (>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 +/- 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 (> 70%) by two US based angiographers independently.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 "severity" score from 0 to 20 for each patient. The severity score was significantly higher for patients with relevant coronary stenosis (5.4 +/- 1.8 vs. 1.7 +/- 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.Conclusions: The new computerized, multiphase, resting ECG analysis device (MultiFunction-CardioGram(sm)) has been shown in this meta-analysis to safely and accurately identify patients with relevant coronary stenosis (> 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.

To assess the sensitivity and specificity of a new computer-enhanced resting electrocardiographic analysis device for the detection of coronary stenosis, 189 patients (aged 61.3+/-12.9 years, 57 women) scheduled for coronary angiography from 4 Asian centers were included in an observational study. Angiographic results were independently classified for hemodynamically relevant stenosis by 2 angiographers. The device calculated a severity score from 0 to 20. The score was significantly higher for patients with coronary stenosis (5.4+/-1.8 vs 1.7+/-2.1). The study device (cutoff 4.0) identified 73 of 77 patients with stenosis (sensitivity 94.8%, specificity 86.6%). Adjusted positive and negative predictive values were 78.4% and 97.1%, respectively (receiver operating characteristic area under the curve, 0.914 [95% confidence interval, 0.868-0.961]). Subgroup analysis showed no significant influence of sex, age, previous revascularization procedures, or participating center. The new computer-enhanced, resting electrocardiographic analysis device appears to identify patients with relevant coronary stenosis with high sensitivity and specificity.

1741: Predicting Coronary Stenosis by Computer-Enhanced,... http://circ.ahajournals.org/cgi/content/meeting_abstract/116/16_Meet... 1 von 2 07.11.2007 20:03 Circulation Home Subscriptions Archives Feedback Authors Help AHA Journals Home This Article Alert me when this article is cited Alert me if a correction is posted Services Email this article to a friend Similar articles in this journal Alert me to new issues of the journal Download to citation manager Request Permissions Google Scholar Articles by Grube, E. Articles by Imhoff, M. PubMed Articles by Grube, E. Articles by Imhoff, M. « Previous Article | Table of

Background: Resting electrocardiogram (ECG) shows limited sensitivity and specificity for the detection of coronary artery disease (CAD). Several methods exist to enhance sensitivity and specificity of resting ECG for diagnosis of CAD, but such methods are not better than a specialist's judgement. We compared a new computer-enhanced, resting ECG analysis device, 3DMP, to coronary angiography to evaluate the device's accuracy in detecting hemodynamically relevant CAD. Methods: A convenience sample of 423 patients without prior coronary revascularization was evaluated with 3DMP before coronary angiography. 3DMP's sensitivity and specificity in detecting hemodynamically relevant coronary stenosis as diagnosed with coronary angiography were calculated as well as odds ratios for the 3DMP severity score and coronary artery disease risk factors. Results: 3DMP identified 179 of 201 patients with hemodynamically relevant stenosis (sensitivity 89.1%, specificity 81.1%). The positive and negative predictive values for identification of coronary stenosis as diagnosed in coronary angiograms were 79% and 90% respectively. CAD risk factors in a logistic regression model had markedly lower predictive power for the presence of coronary stenosis in patients than did 3DMP severity score (odds ratio 3.35 [2.24-5.01] vs. 34.87 [20.00-60.79]). Logistic regression combining severity score with risk factors did not add significantly to the prediction quality (odds ratio 36.73 [20.92-64.51]). Conclusions: 3DMP's computer-based, mathematically derived analysis of resting two-lead ECG data provides detection of hemodynamically relevant CAD with high sensitivity and specificity that appears to be at least as good as those reported for other resting and/or stress ECG methods currently used in clinical practice.

Background: Resting electrocardiogram (ECG) shows limited sensitivity and specificity for the detection of coronary artery disease (CAD). We wanted to evaluate a new computer-enhanced resting ECG d...

Noninvasive methods of identifying coronary artery disease are not consistently accurate. To identify abnormalities associated with angiographically determined coronary artery disease, the authors sought to quantify the utility of a new device, a digital database-driven multiphase electrocardiograph system (3DMP), which produces a computer-enhanced frequency/time-domain resting electrocardiogram, in conjunction with a 12-lead electrocardiogram. The authors compared resting 3DMP results from those of coronary angiograms to identify abnormalities associated with coronary artery disease in a random sample of 136 patients. Using a discrete-Fourier transform signal-averaging variant and a series of mathematic transformations, the computer-expert system analyzed signals in the 0.1- to 50-Hz range. The system identified abnormalities by comparing results with a 21,000-patient database culled from predicate research. The system detected abnormalities in 96.0% of patients subsequently found to have 70% or greater stenosis by angiography. For patients with a 40% or less times a more than 50% occlusion, the system detected abnormalities in 75% of cases. For patients with a 50% or less times a 70% or less occlusion, it detected abnormalities in 90% of cases. Overall sensitivity for the study was 93.3% (positive predictive value, 91.2%; specificity, 83%; negative predictive value, 86.7%). No gender differences were detected. A 3DMP electrocardiograph system combined with 12-lead electrocardiography appears to have measurable, diagnostic utility in identifying 3DMP abnormalities associated with coronary artery disease, and warrants further study.