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Diagnostic accuracy of a new cardiac electrical biomarker for detection of
electrocardiogram changes suggestive of acute myocardial ischemic injury
#MMPMID24118724
Schreck DM
; Fishberg RD
Ann Noninvasive Electrocardiol
2014[Mar]; 19
(2
): 129-44
PMID24118724
show ga
OBJECTIVE: A new cardiac "electrical" biomarker (CEB) for detection of 12-lead
electrocardiogram (ECG) changes indicative of acute myocardial ischemic injury
has been identified. Objective was to test CEB diagnostic accuracy. METHODS: This
is a blinded, observational retrospective case-control, noninferiority study. A
total of 508 ECGs obtained from archived digital databases were interpreted by
cardiologist and emergency physician (EP) blinded reference standards for
presence of acute myocardial ischemic injury. CEB was constructed from three ECG
cardiac monitoring leads using nonlinear modeling. Comparative active controls
included ST voltage changes (J-point, ST area under curve) and a computerized ECG
interpretive algorithm (ECGI). Training set of 141 ECGs identified CEB cutoffs by
receiver-operating-characteristic (ROC) analysis. Test set of 367 ECGs was
analyzed for validation. Poor-quality ECGs were excluded. Sensitivity,
specificity, and negative and positive predictive values were calculated with 95%
confidence intervals. Adjudication was performed by consensus. RESULTS: CEB
demonstrated noninferiority to all active controls by hypothesis testing. CEB
adjudication demonstrated 85.3-94.4% sensitivity, 92.5-93.0% specificity,
93.8-98.6% negative predictive value, and 74.6-83.5% positive predictive value.
CEB was superior against all active controls in EP analysis, and against ST area
under curve and ECGI by cardiologist. CONCLUSION: CEB detects acute myocardial
ischemic injury with high diagnostic accuracy. CEB is instantly constructed from
three ECG leads on the cardiac monitor and displayed instantly allowing immediate
cost-effective identification of patients with acute ischemic injury during
cardiac rhythm monitoring.
|Biomarkers
[MESH]
|Case-Control Studies
[MESH]
|Electrocardiography/*methods/*statistics & numerical data
[MESH]