Journal
AMERICAN HEART JOURNAL
Volume 171, Issue 1, Pages 92-102Publisher
MOSBY-ELSEVIER
DOI: 10.1016/j.ahj.2015.07.022
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Funding
- Swiss National Science Foundation [PASMP3-136995]
- Swiss Heart Foundation
- Cardiovascular Research Foundation Basel
- 8sense
- Abbott
- ALERE
- Brahms
- Critical Diagnostics
- Nanosphere
- Roche
- Siemens
- University Hospital Basel
- University of Basel
- Professor Max Cloetta Foundation
- Department of Internal Medicine
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Objective We aimed to prospectively derive and validate a novel 0-/1-hour algorithm using high-sensitivity cardiac troponin I (hs-cTnI) for the early rule-out and rule-in of acute myocardial infarction (AMI). Methods In a prospective multicenter diagnostic study, we enrolled 1,500 patients presenting with suspected AMI to the emergency department. The final diagnosis was centrally adjudicated by 2 independent cardiologists blinded to hs-cTnI concentrations. The hs-cTnI (Siemens Vista) 0-/1-hour algorithm incorporated measurements performed at baseline and absolute changes within 1 hour, was derived in the first 750 patients (derivation cohort), and then validated in the second 750 (validation cohort). Results Overall, AMI was the final diagnosis in 16% of patients. Applying the hs-cTnI 0-/1-hour algorithm developed in the derivation cohort to the validation cohort, 57% of patients could be classified as rule-out; 10%, as rule-in; and 33%, as observe. In the validation cohort, the sensitivity and the negative predictive value for AMI in the rule-out zone were 100% (95% CI 96%100%) and 100% (95% CI 99%-100%), respectively. The specificity and the positive predictive value (PPV) for AMI in the rule-in zone were 96% (95% CI 94%-97%) and 70% (95% CI 60%-79%), respectively. Negative predictive value and positive predictive value of the 0-/1-hour algorithm were higher compared to the standard of care combining hs-cTnI with the electrocardiogram (both P<.001). Conclusion The hs-cTnI 0-/1-hour algorithm performs very well for early rule-out as well as rule-in of AMI. The clinical implications are that used in conjunction with all other clinical information, the 0-/1-hour algorithm will be a safe and effective approach to substantially reduce time to diagnosis.
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