Early Diagnosis of Myocardial Infarction With Point-of-Care High-Sensitivity Cardiac Troponin I
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Early Diagnosis of Myocardial Infarction With Point-of-Care High-Sensitivity Cardiac Troponin I. / Boeddinghaus, Jasper; Nestelberger, Thomas; Koechlin, Luca; Wussler, Desiree; Lopez-Ayala, Pedro; Walter, Joan Elias; Troester, Valentina; Ratmann, Paul David; Seidel, Funda; Zimmermann, Tobias; Badertscher, Patrick; Wildi, Karin; Rubini Giménez, Maria; Potlukova, Eliska; Strebel, Ivo; Freese, Michael; Miró, Òscar; Martin-Sanchez, F Javier; Kawecki, Damian; Keller, Dagmar I; Gualandro, Danielle M; Christ, Michael; Twerenbold, Raphael; Mueller, Christian; APACE Investigators.
in: J AM COLL CARDIOL, Jahrgang 75, Nr. 10, 17.03.2020, S. 1111-1124.Publikationen: SCORING: Beitrag in Fachzeitschrift/Zeitung › SCORING: Zeitschriftenaufsatz › Forschung › Begutachtung
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TY - JOUR
T1 - Early Diagnosis of Myocardial Infarction With Point-of-Care High-Sensitivity Cardiac Troponin I
AU - Boeddinghaus, Jasper
AU - Nestelberger, Thomas
AU - Koechlin, Luca
AU - Wussler, Desiree
AU - Lopez-Ayala, Pedro
AU - Walter, Joan Elias
AU - Troester, Valentina
AU - Ratmann, Paul David
AU - Seidel, Funda
AU - Zimmermann, Tobias
AU - Badertscher, Patrick
AU - Wildi, Karin
AU - Rubini Giménez, Maria
AU - Potlukova, Eliska
AU - Strebel, Ivo
AU - Freese, Michael
AU - Miró, Òscar
AU - Martin-Sanchez, F Javier
AU - Kawecki, Damian
AU - Keller, Dagmar I
AU - Gualandro, Danielle M
AU - Christ, Michael
AU - Twerenbold, Raphael
AU - Mueller, Christian
AU - APACE Investigators
N1 - Copyright © 2020 The Authors. Published by Elsevier Inc. All rights reserved.
PY - 2020/3/17
Y1 - 2020/3/17
N2 - BACKGROUND: Until now, high-sensitivity cardiac troponin (hs-cTn) assays were mainly developed for large central laboratory platforms.OBJECTIVES: This study aimed to assess the clinical performance of a point-of-care (POC)-hs-cTnI assay in patients with suspected myocardial infarction (MI).METHODS: This study enrolled patients presenting to the emergency department with symptoms suggestive of MI. Two cardiologists centrally adjudicated the final diagnosis using all clinical data including cardiac imaging. The primary objective was to directly compare diagnostic accuracy of POC-hs-cTnI-TriageTrue versus best-validated central laboratory assays. Secondary objectives included the derivation and validation of a POC-hs-cTnI-TriageTrue-specific 0/1-h algorithm.RESULTS: MI was the adjudicated final diagnosis in 178 of 1,261 patients (14%). The area under the curve (AUC) for POC-hs-cTnI-TriageTrue at presentation was 0.95 (95% confidence interval [CI]: 0.93 to 0.96) and was at least comparable to hs-cTnT-Elecsys (AUC: 0.94; 95% CI: 0.93 to 0.96; p = 0.213) and hs-cTnI-Architect (AUC: 0.92; 95% CI: 0.90 to 0.93; p < 0.001). A single cutoff concentration <3 ng/l at presentation identified 45% of patients at low risk with a negative predictive value (NPV) of 100% (95% CI: 99.4% to 100%). A single cutoff concentration >60 ng/l identified patients at high risk with a positive predictive value (PPV) of 76.8% (95% CI: 68.9% to 83.6%). The 0/1-h algorithm ruled out 55% of patients (NPV: 100%; 95% CI: 98.8% to 100%), and ruled in 18% of patients (PPV: 76.8%; 95% CI: 67.2% to 84.7%). Ruled-out patients had cumulative event rates of 0% at 30 days and 1.6% at 2 years. This study confirmed these findings in a secondary analysis including hs-cTnI-Architect for central adjudication.CONCLUSIONS: The POC-hs-cTnI-TriageTrue assay provides high diagnostic accuracy in patients with suspected MI with a clinical performance that is at least comparable to that of best-validated central laboratory assays. (Advantageous Predictors of Acute Coronary Syndromes Evaluation Study [APACE]; NCT00470587).
AB - BACKGROUND: Until now, high-sensitivity cardiac troponin (hs-cTn) assays were mainly developed for large central laboratory platforms.OBJECTIVES: This study aimed to assess the clinical performance of a point-of-care (POC)-hs-cTnI assay in patients with suspected myocardial infarction (MI).METHODS: This study enrolled patients presenting to the emergency department with symptoms suggestive of MI. Two cardiologists centrally adjudicated the final diagnosis using all clinical data including cardiac imaging. The primary objective was to directly compare diagnostic accuracy of POC-hs-cTnI-TriageTrue versus best-validated central laboratory assays. Secondary objectives included the derivation and validation of a POC-hs-cTnI-TriageTrue-specific 0/1-h algorithm.RESULTS: MI was the adjudicated final diagnosis in 178 of 1,261 patients (14%). The area under the curve (AUC) for POC-hs-cTnI-TriageTrue at presentation was 0.95 (95% confidence interval [CI]: 0.93 to 0.96) and was at least comparable to hs-cTnT-Elecsys (AUC: 0.94; 95% CI: 0.93 to 0.96; p = 0.213) and hs-cTnI-Architect (AUC: 0.92; 95% CI: 0.90 to 0.93; p < 0.001). A single cutoff concentration <3 ng/l at presentation identified 45% of patients at low risk with a negative predictive value (NPV) of 100% (95% CI: 99.4% to 100%). A single cutoff concentration >60 ng/l identified patients at high risk with a positive predictive value (PPV) of 76.8% (95% CI: 68.9% to 83.6%). The 0/1-h algorithm ruled out 55% of patients (NPV: 100%; 95% CI: 98.8% to 100%), and ruled in 18% of patients (PPV: 76.8%; 95% CI: 67.2% to 84.7%). Ruled-out patients had cumulative event rates of 0% at 30 days and 1.6% at 2 years. This study confirmed these findings in a secondary analysis including hs-cTnI-Architect for central adjudication.CONCLUSIONS: The POC-hs-cTnI-TriageTrue assay provides high diagnostic accuracy in patients with suspected MI with a clinical performance that is at least comparable to that of best-validated central laboratory assays. (Advantageous Predictors of Acute Coronary Syndromes Evaluation Study [APACE]; NCT00470587).
KW - Aged
KW - Aged, 80 and over
KW - Biomarkers/blood
KW - Early Diagnosis
KW - Emergency Service, Hospital
KW - Female
KW - Follow-Up Studies
KW - Humans
KW - Male
KW - Middle Aged
KW - Myocardial Infarction/blood
KW - Point-of-Care Systems
KW - Prospective Studies
KW - Troponin I/blood
U2 - 10.1016/j.jacc.2019.12.065
DO - 10.1016/j.jacc.2019.12.065
M3 - SCORING: Journal article
C2 - 32164884
VL - 75
SP - 1111
EP - 1124
JO - J AM COLL CARDIOL
JF - J AM COLL CARDIOL
SN - 0735-1097
IS - 10
ER -