• Medientyp: E-Artikel
  • Titel: Two-Hour Algorithm for Rapid Triage of Suspected Acute Myocardial Infarction Using a High-Sensitivity Cardiac Troponin I Assay
  • Beteiligte: Nestelberger, Thomas; Boeddinghaus, Jasper; Greenslade, Jaimi; Parsonage, William A; Than, Martin; Wussler, Desiree; Lopez-Ayala, Pedro; Zimmermann, Tobias; Meier, Mario; Troester, Valentina; Badertscher, Patrick; Koechlin, Luca; Wildi, Karin; Anwar, Mahnoor; Freese, Michael; Keller, Dagmar I; Reichlin, Tobias; Twerenbold, Raphael; Cullen, Louise; Mueller, Christian; Puelacher, Christian; du Fay de Lavallaz, Jeanne; Rubini Giménez, Maria; Strebel, Ivo; [...]
  • Erschienen: Oxford University Press (OUP), 2019
  • Erschienen in: Clinical Chemistry
  • Umfang: 1437-1447
  • Sprache: Englisch
  • DOI: 10.1373/clinchem.2019.305193
  • ISSN: 0009-9147; 1530-8561
  • Schlagwörter: Biochemistry (medical) ; Clinical Biochemistry
  • Zusammenfassung: <jats:title>Abstract</jats:title> <jats:sec> <jats:title>BACKGROUND</jats:title> <jats:p>We aimed to derive and externally validate a 0/2-h algorithm using the high-sensitivity cardiac troponin I (hs-cTnI)-Access assay.</jats:p> </jats:sec> <jats:sec> <jats:title>METHODS</jats:title> <jats:p>We enrolled patients presenting to the emergency department with symptoms suggestive of acute myocardial infarction (AMI) in 2 prospective diagnostic studies using central adjudication. Two independent cardiologists adjudicated the final diagnosis, including all available medical information including cardiac imaging. hs-cTnI-Access concentrations were measured at presentation and after 2 h in a blinded fashion.</jats:p> </jats:sec> <jats:sec> <jats:title>RESULTS</jats:title> <jats:p>AMI was the adjudicated final diagnosis in 164 of 1131 (14.5%) patients in the derivation cohort. Rule-out by the hs-cTnI-Access 0/2-h algorithm was defined as 0-h hs-cTnI-Access concentration &amp;lt;4 ng/L in patients with an onset of chest pain &amp;gt;3 h (direct rule-out) or a 0-h hs-cTnI-Access concentration &amp;lt;5 ng/L and an absolute change within 2 h &amp;lt;5 ng/L in all other patients. Derived thresholds for rule-in were a 0-h hs-cTnI-Access concentration ≥50 ng/L (direct rule-in) or an absolute change within 2 h ≥20 ng/L. In the derivation cohort, these cutoffs ruled out 55% of patients with a negative predictive value (NPV) of 99.8% (95% CI, 99.3–100) and sensitivity of 99.4% (95% CI, 96.5–99.9), and ruled in 30% of patients with a positive predictive value (PPV) of 73% (95% CI, 66.1–79). In the validation cohort, AMI was the adjudicated final diagnosis in 88 of 1280 (6.9%) patients. These cutoffs ruled out 77.9% of patients with an NPV of 99.8% (95% CI, 99.3–100) and sensitivity of 97.7% (95% CI, 92.0–99.7), and ruled in 5.8% of patients with a PPV of 77% (95% CI, 65.8–86) in the validation cohort.</jats:p> </jats:sec> <jats:sec> <jats:title>CONCLUSIONS</jats:title> <jats:p>Safety and efficacy of the l hs-cTnI-Access 0/2-h algorithm for triage toward rule-out or rule-in of AMI are very high.</jats:p> </jats:sec> <jats:sec> <jats:title>TRIAL REGISTRATION</jats:title> <jats:p>APACE, NCT00470587; ADAPT, ACTRN1261100106994; IMPACT, ACTRN12611000206921.</jats:p> </jats:sec>
  • Beschreibung: <jats:title>Abstract</jats:title>
    <jats:sec>
    <jats:title>BACKGROUND</jats:title>
    <jats:p>We aimed to derive and externally validate a 0/2-h algorithm using the high-sensitivity cardiac troponin I (hs-cTnI)-Access assay.</jats:p>
    </jats:sec>
    <jats:sec>
    <jats:title>METHODS</jats:title>
    <jats:p>We enrolled patients presenting to the emergency department with symptoms suggestive of acute myocardial infarction (AMI) in 2 prospective diagnostic studies using central adjudication. Two independent cardiologists adjudicated the final diagnosis, including all available medical information including cardiac imaging. hs-cTnI-Access concentrations were measured at presentation and after 2 h in a blinded fashion.</jats:p>
    </jats:sec>
    <jats:sec>
    <jats:title>RESULTS</jats:title>
    <jats:p>AMI was the adjudicated final diagnosis in 164 of 1131 (14.5%) patients in the derivation cohort. Rule-out by the hs-cTnI-Access 0/2-h algorithm was defined as 0-h hs-cTnI-Access concentration &amp;lt;4 ng/L in patients with an onset of chest pain &amp;gt;3 h (direct rule-out) or a 0-h hs-cTnI-Access concentration &amp;lt;5 ng/L and an absolute change within 2 h &amp;lt;5 ng/L in all other patients. Derived thresholds for rule-in were a 0-h hs-cTnI-Access concentration ≥50 ng/L (direct rule-in) or an absolute change within 2 h ≥20 ng/L. In the derivation cohort, these cutoffs ruled out 55% of patients with a negative predictive value (NPV) of 99.8% (95% CI, 99.3–100) and sensitivity of 99.4% (95% CI, 96.5–99.9), and ruled in 30% of patients with a positive predictive value (PPV) of 73% (95% CI, 66.1–79). In the validation cohort, AMI was the adjudicated final diagnosis in 88 of 1280 (6.9%) patients. These cutoffs ruled out 77.9% of patients with an NPV of 99.8% (95% CI, 99.3–100) and sensitivity of 97.7% (95% CI, 92.0–99.7), and ruled in 5.8% of patients with a PPV of 77% (95% CI, 65.8–86) in the validation cohort.</jats:p>
    </jats:sec>
    <jats:sec>
    <jats:title>CONCLUSIONS</jats:title>
    <jats:p>Safety and efficacy of the l hs-cTnI-Access 0/2-h algorithm for triage toward rule-out or rule-in of AMI are very high.</jats:p>
    </jats:sec>
    <jats:sec>
    <jats:title>TRIAL REGISTRATION</jats:title>
    <jats:p>APACE, NCT00470587; ADAPT, ACTRN1261100106994; IMPACT, ACTRN12611000206921.</jats:p>
    </jats:sec>
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