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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.
Highlights
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What question this study addressed Whether 2 high-sensitivity troponin values at 0 and 1 hour can rapidly classify patients into 3 groups: no acute myocardial infarction, acute myocardial infarction, and indeterminate
Selection of Participants Patients presenting to the emergency department (ED) with symptoms suggestive of acute myocardial infarction with an onset or maximum of discomfort or pain within the previous 6 hours were identified by study personnel and recruited after written informed consent had been obtained
Summary
Patients with symptoms suggestive of acute myocardial infarction account for approximately 10% of all emergency department (ED) consultations.[1,2,3] The 12-lead ECG and cardiac troponin (cTn) form the cornerstones for the diagnosis of acute myocardial infarction and complement clinical assessment.[1,2,3] A limitation of former-generation cTn assays is the inability to detect low levels of cTn and the associated need for prolonged serial sampling for 6 to 12 hours.[1,2,4] Delays in diagnosing disease (rule-in delays) hold back prompt use of evidence-based therapies.[1,2]. What question this study addressed Whether 2 high-sensitivity troponin (hs-cTnT) values at 0 and 1 hour can rapidly classify patients into 3 groups: no acute myocardial infarction, acute myocardial infarction, and indeterminate
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