Christian Mueller1, Evangelos Giannitsis2, Michael Christ3, Jorge Ordóñez-Llanos4, Christopher deFilippi5, James McCord6, Richard Body7, Mauro Panteghini8, Tomas Jernberg9, Mario Plebani10, Franck Verschuren11, John French12, Robert Christenson13, Silvia Weiser14, Garnet Bendig14, Peter Dilba14, Bertil Lindahl15. 1. Department of Cardiology and Cardiovascular Research Institute Basel, University Hospital Basel, Basel, Switzerland. Electronic address: chmueller@uhbs.ch. 2. University Hospital Heidelberg, Heidelberg, Germany. 3. Department of Emergency and Critical Care Medicine, General Hospital, Paracelsus Medical University, Nuremberg, Germany. 4. Department of Clinical Biochemistry, Institut d'Investigacions Biomèdiques Sant Pau, Barcelona, Spain. 5. Department of Medicine, University of Maryland School of Medicine, Baltimore, MD. 6. Henry Ford Heart and Vascular Institute, Henry Ford Health System, Detroit, MI. 7. Central Manchester University Hospitals NHS Foundation Trust, Manchester, UK. 8. Department of Biomedical and Clinical Sciences "Luigi Sacco," University of Milan Medical School, Milan, Italy. 9. Department of Medicine, Karolinska Institutet, Huddinge, Sweden. 10. Department of Laboratory Medicine, University Hospital of Padova, Padua, Italy. 11. Department of Acute Medicine, Cliniques Universitaires St-Luc and Université Catholique de Louvain, Brussels, Belgium. 12. Liverpool Hospital and University of New South Wales, Liverpool, NSW, Australia. 13. Department of Pathology, University of Maryland School of Medicine, Baltimore, MD. 14. Roche Diagnostics Germany, Penzberg, Germany. 15. Department of Medical Sciences and Uppsala Clinical Research Center, Uppsala University, Uppsala, Sweden.
Abstract
STUDY OBJECTIVE: We aim to prospectively validate the diagnostic accuracy of the recently developed 0-h/1-h algorithm, using high-sensitivity cardiac troponin T (hs-cTnT) for the early rule-out and rule-in of acute myocardial infarction. METHODS: We enrolled patients presenting with suspected acute myocardial infarction and recent (<6 hours) onset of symptoms to the emergency department in a global multicenter diagnostic study. Hs-cTnT (Roche Diagnostics) and sensitive cardiac troponin I (Siemens Healthcare) were measured at presentation and after 1 hour, 2 hours, and 4 to 14 hours in a central laboratory. Patient triage according to the predefined hs-cTnT 0-hour/1-hour algorithm (hs-cTnT below 12 ng/L and Δ1 hour below 3 ng/L to rule out; hs-cTnT at least 52 ng/L or Δ1 hour at least 5 ng/L to rule in; remaining patients to the "observational zone") was compared against a centrally adjudicated final diagnosis by 2 independent cardiologists (reference standard). The final diagnosis was based on all available information, including coronary angiography and echocardiography results, follow-up data, and serial measurements of sensitive cardiac troponin I, whereas adjudicators remained blinded to hs-cTnT. RESULTS: Among 1,282 patients enrolled, acute myocardial infarction was the final diagnosis for 213 (16.6%) patients. Applying the hs-cTnT 0-hour/1-hour algorithm, 813 (63.4%) patients were classified as rule out, 184 (14.4%) were classified as rule in, and 285 (22.2%) were triaged to the observational zone. This resulted in a negative predictive value and sensitivity for acute myocardial infarction of 99.1% (95% confidence interval [CI] 98.2% to 99.7%) and 96.7% (95% CI 93.4% to 98.7%) in the rule-out zone (7 patients with false-negative results), a positive predictive value and specificity for acute myocardial infarction of 77.2% (95% CI 70.4% to 83.0%) and 96.1% (95% CI 94.7% to 97.2%) in the rule-in zone, and a prevalence of acute myocardial infarction of 22.5% in the observational zone. CONCLUSION: The hs-cTnT 0-hour/1-hour algorithm performs well for early rule-out and rule-in of acute myocardial infarction.
STUDY OBJECTIVE: We aim to prospectively validate the diagnostic accuracy of the recently developed 0-h/1-h algorithm, using high-sensitivity cardiac troponin T (hs-cTnT) for the early rule-out and rule-in of acute myocardial infarction. METHODS: We enrolled patients presenting with suspected acute myocardial infarction and recent (<6 hours) onset of symptoms to the emergency department in a global multicenter diagnostic study. Hs-cTnT (Roche Diagnostics) and sensitive cardiac troponin I (Siemens Healthcare) were measured at presentation and after 1 hour, 2 hours, and 4 to 14 hours in a central laboratory. Patient triage according to the predefined hs-cTnT 0-hour/1-hour algorithm (hs-cTnT below 12 ng/L and Δ1 hour below 3 ng/L to rule out; hs-cTnT at least 52 ng/L or Δ1 hour at least 5 ng/L to rule in; remaining patients to the "observational zone") was compared against a centrally adjudicated final diagnosis by 2 independent cardiologists (reference standard). The final diagnosis was based on all available information, including coronary angiography and echocardiography results, follow-up data, and serial measurements of sensitive cardiac troponin I, whereas adjudicators remained blinded to hs-cTnT. RESULTS: Among 1,282 patients enrolled, acute myocardial infarction was the final diagnosis for 213 (16.6%) patients. Applying the hs-cTnT 0-hour/1-hour algorithm, 813 (63.4%) patients were classified as rule out, 184 (14.4%) were classified as rule in, and 285 (22.2%) were triaged to the observational zone. This resulted in a negative predictive value and sensitivity for acute myocardial infarction of 99.1% (95% confidence interval [CI] 98.2% to 99.7%) and 96.7% (95% CI 93.4% to 98.7%) in the rule-out zone (7 patients with false-negative results), a positive predictive value and specificity for acute myocardial infarction of 77.2% (95% CI 70.4% to 83.0%) and 96.1% (95% CI 94.7% to 97.2%) in the rule-in zone, and a prevalence of acute myocardial infarction of 22.5% in the observational zone. CONCLUSION: The hs-cTnT 0-hour/1-hour algorithm performs well for early rule-out and rule-in of acute myocardial infarction.
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