Detection of acute myocardial ischemic injury by gender using a novel cardiac electrical biomarker.

OBJECTIVE The objective of this study us to stratify by gender a new cardiac electrical biomarker (CEB) diagnostic accuracy for detection of acute myocardial ischemic injury (AMII). METHODS This is a noninferiority retrospective, case-control, blinded study of 310 archived measured electrocardiograms (ECGs) acquired from 218 men and 92 women. The CEB is constructed from the derived ECG (dECG) synthesized from 3 leads. Electrocardiograms were included if acquired less than or equal to 1 day from patient presentation. Electrocardiograms were interpreted by 2 blinded physicians and adjudicated by consensus. Standard ST analyses and computerized ECG interpretations were active controls. Electrocardiograms were excluded for noise and baseline wander, age younger than 18 years, and ectopic beats in the 10-second ECG acquisition. Diagnostic accuracy measures of sensitivity, specificity, positive and negative predictive values, and likelihood ratios were stratified by gender. Measured vs derived ECG correlations were quantitatively compared using Pearson correlation and qualitatively by percent agreement methodology. RESULTS The CEB sensitivities for AMII detection in men and women were 93.9% and 90.5%, respectively, and CEB specificities were 90.7% and 95.2%, respectively, and were superior to active controls. Derived and measured ECGs showed high correlation for both men and women with r = 0.857 and r = 0.893, respectively. Reference standard intra-agreement analysis for measured ECGs and dECGs with AMII was 99.4%. CONCLUSIONS The CEB demonstrates high diagnostic accuracy for detection of AMII in men and women. The ECG can be derived with accuracy from 3 leads. This technology is an efficient real-time method of identifying patients with AMII who are being monitored in acute care settings.