Two-Hour Algorithm for Rapid Triage of Suspected Acute Myocardial Infarction Using a High-Sensitivity Cardiac Troponin I Assay. (1st November 2019)

• Record Type: Journal Article
• Authors: 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; Walter, Joan; Huber, Jeffrey; Christ, Michael; Kozhuharov, Nikola; Gualandro, Danielle M; Potlukova, Eliska; Baumgartner, Benjamin; Hafner, Benjamin; Rentsch, Katharina; Miró, Òscar; Fuenzalida, Carolina; Gil, Beatriz; Martin-Sanchez, F Javier; Kawecki, Damian; Geigy, Nicolas; Meissner, Kathrin; Kulangara, Caroline; López, Beatriz; Rodriguez Adrada, Esther; Ganovská, Eva; Lohrmann, Jens; Kloos, Wanda; Steude, Jana; Buser, Andreas; von Eckardstein, Arnold; Nowalany-Kozielska, Ewa; Muzyk, Piotr;
• Is Part Of: Clinical chemistry. Volume 65:Number 11(2019)
• Page Start: 1437
• Page End: 1447
• Publication Date: 2019-11-01
• Subjects: Clinical chemistry -- Periodicals; Pharmaceutical chemistry -- Periodicals; Biochemistry -- Periodicals; Biochimie -- Périodiques; Diagnostics biologiques -- Périodiques; Biochemistry; Clinical chemistry; Pharmaceutical chemistry; Biochemistry; Laboratory Techniques and Procedures; Klinische chemie; Periodicals; 616.075605
• DOI: 10.1373/clinchem.2019.305193
• Languages: English
• ISSNs: 0009-9147

Abstract

Abstract: BACKGROUND: We aimed to derive and externally validate a 0/2-h algorithm using the high-sensitivity cardiac troponin I (hs-cTnI)-Access assay. METHODS: 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. RESULTS: 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 <4 ng/L in patients with an onset of chest pain >3 h (direct rule-out) or a 0-h hs-cTnI-Access concentration <5 ng/L and an absolute change within 2 h <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. CONCLUSIONS: 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. TRIAL REGISTRATION: APACE, NCT00470587; ADAPT, ACTRN1261100106994; IMPACT, ACTRN12611000206921.