title: Multicenter Evaluation of a 0-Hour/1-Hour Algorithm in the Diagnosis of Myocardial Infarction With High-Sensitivity Cardiac Troponin T.
abstract: 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.
  
  
  
  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.
  
  
  
  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.
  
  
  
  The hs-cTnT 0-hour/1-hour algorithm performs well for early rule-out and rule-in of acute myocardial infarction.
authors.affiliation: Department of Cardiology and Cardiovascular Research Institute Basel, University Hospital Basel, Basel, Switzerland. Electronic address: chmueller@uhbs.ch.
authors.forename: Christian
authors.initials: C
authors.lastname: Mueller
authors.affiliation: University Hospital Heidelberg, Heidelberg, Germany.
authors.forename: Evangelos
authors.initials: E
authors.lastname: Giannitsis
authors.affiliation: Department of Emergency and Critical Care Medicine, General Hospital, Paracelsus Medical University, Nuremberg, Germany.
authors.forename: Michael
authors.initials: M
authors.lastname: Christ
authors.affiliation: Department of Clinical Biochemistry, Institut d'Investigacions Biomèdiques Sant Pau, Barcelona, Spain.
authors.forename: Jorge
authors.initials: J
authors.lastname: Ordóñez-Llanos
authors.affiliation: Department of Medicine, University of Maryland School of Medicine, Baltimore, MD.
authors.forename: Christopher
authors.initials: C
authors.lastname: deFilippi
authors.affiliation: Henry Ford Heart and Vascular Institute, Henry Ford Health System, Detroit, MI.
authors.forename: James
authors.initials: J
authors.lastname: McCord
authors.affiliation: Central Manchester University Hospitals NHS Foundation Trust, Manchester, UK.
authors.forename: Richard
authors.initials: R
authors.lastname: Body
authors.affiliation: Department of Biomedical and Clinical Sciences "Luigi Sacco," University of Milan Medical School, Milan, Italy.
authors.forename: Mauro
authors.initials: M
authors.lastname: Panteghini
authors.affiliation: Department of Medicine, Karolinska Institutet, Huddinge, Sweden.
authors.forename: Tomas
authors.initials: T
authors.lastname: Jernberg
authors.affiliation: Department of Laboratory Medicine, University Hospital of Padova, Padua, Italy.
authors.forename: Mario
authors.initials: M
authors.lastname: Plebani
authors.affiliation: Department of Acute Medicine, Cliniques Universitaires St-Luc and Université Catholique de Louvain, Brussels, Belgium.
authors.forename: Franck
authors.initials: F
authors.lastname: Verschuren
authors.affiliation: Liverpool Hospital and University of New South Wales, Liverpool, NSW, Australia.
authors.forename: John
authors.initials: J
authors.lastname: French
authors.affiliation: Department of Pathology, University of Maryland School of Medicine, Baltimore, MD.
authors.forename: Robert
authors.initials: R
authors.lastname: Christenson
authors.affiliation: Roche Diagnostics Germany, Penzberg, Germany.
authors.forename: Silvia
authors.initials: S
authors.lastname: Weiser
authors.affiliation: Roche Diagnostics Germany, Penzberg, Germany.
authors.forename: Garnet
authors.initials: G
authors.lastname: Bendig
authors.affiliation: Roche Diagnostics Germany, Penzberg, Germany.
authors.forename: Peter
authors.initials: P
authors.lastname: Dilba
authors.affiliation: Department of Medical Sciences and Uppsala Clinical Research Center, Uppsala University, Uppsala, Sweden.
authors.forename: Bertil
authors.initials: B
authors.lastname: Lindahl
mesh_terms: D000368:Aged; D000369:Aged, 80 and over; D000465:Algorithms; D004562:Electrocardiography; D004636:Emergency Service, Hospital; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D009203:Myocardial Infarction / Q000097:blood / Q000175:diagnosis* / Q000503:physiopathology; D013997:Time Factors; D020107:Troponin T / Q000097:blood*
chemical_list: D020107:Troponin T