Early Diagnosis of Myocardial Infarction With Point-of-Care High-Sensitivity Cardiac Troponin I

Jasper Boeddinghaus; Thomas Nestelberger; Luca Koechlin; Desiree Wussler; Pedro Lopez-Ayala; Joan Elias Walter; Valentina Troester; Paul David Ratmann; Funda Seidel; Tobias Zimmermann; Patrick Badertscher; Karin Wildi; Maria Rubini Giménez; Eliska Potlukova; Ivo Strebel; Michael Freese; Òscar Miró; F Javier Martin-Sanchez; Damian Kawecki; Dagmar I Keller; Danielle M Gualandro; Michael Christ; Raphael Twerenbold; Christian Mueller; APACE Investigators

doi:10.1016/j.jacc.2019.12.065

Early Diagnosis of Myocardial Infarction With Point-of-Care High-Sensitivity Cardiac Troponin I

J Am Coll Cardiol. 2020 Mar 17;75(10):1111-1124. doi: 10.1016/j.jacc.2019.12.065.

Authors

Jasper Boeddinghaus¹, Thomas Nestelberger², Luca Koechlin³, Desiree Wussler⁴, Pedro Lopez-Ayala⁵, Joan Elias Walter⁴, Valentina Troester⁵, Paul David Ratmann⁵, Funda Seidel⁵, Tobias Zimmermann⁴, Patrick Badertscher⁶, Karin Wildi⁷, Maria Rubini Giménez⁸, Eliska Potlukova⁴, Ivo Strebel⁵, Michael Freese⁵, Òscar Miró⁹, F Javier Martin-Sanchez¹⁰, Damian Kawecki¹¹, Dagmar I Keller¹², Danielle M Gualandro¹³, Michael Christ¹⁴, Raphael Twerenbold⁵, Christian Mueller¹⁵; APACE Investigators

Affiliations

¹ Cardiovascular Research Institute Basel and Department of Cardiology, University Hospital Basel, University of Basel, Switzerland; GREAT Network, Rome, Italy. Electronic address: https://twitter.com/J_Boeddinghaus.
² Cardiovascular Research Institute Basel and Department of Cardiology, University Hospital Basel, University of Basel, Switzerland; GREAT Network, Rome, Italy. Electronic address: https://twitter.com/thomas_nest.
³ Cardiovascular Research Institute Basel and Department of Cardiology, University Hospital Basel, University of Basel, Switzerland; GREAT Network, Rome, Italy; Department of Cardiac Surgery, University Hospital Basel, University of Basel, Basel, Switzerland.
⁴ Cardiovascular Research Institute Basel and Department of Cardiology, University Hospital Basel, University of Basel, Switzerland; GREAT Network, Rome, Italy; Division of Internal Medicine, University Hospital Basel, University of Basel, Basel, Switzerland.
⁵ Cardiovascular Research Institute Basel and Department of Cardiology, University Hospital Basel, University of Basel, Switzerland; GREAT Network, Rome, Italy.
⁶ Cardiovascular Research Institute Basel and Department of Cardiology, University Hospital Basel, University of Basel, Switzerland; GREAT Network, Rome, Italy; Division of Cardiology, Medical University of South Carolina, Charleston, South Carolina.
⁷ Cardiovascular Research Institute Basel and Department of Cardiology, University Hospital Basel, University of Basel, Switzerland; GREAT Network, Rome, Italy; Critical Care Research Group, the Prince Charles Hospital, Brisbane and the University of Queensland, Brisbane, Queensland, Australia.
⁸ Cardiovascular Research Institute Basel and Department of Cardiology, University Hospital Basel, University of Basel, Switzerland; GREAT Network, Rome, Italy; Leipzig Heart Center, Leipzig, Germany.
⁹ GREAT Network, Rome, Italy; Emergency Department, Hospital Clinic, Barcelona, Catalonia, Spain.
¹⁰ GREAT Network, Rome, Italy; Servicio de Urgencias, Hospital Clínico San Carlos, Madrid, Spain.
¹¹ GREAT Network, Rome, Italy; Second Department of Cardiology, School of Medicine with the Division of Dentistry in Zabrze, Medical University of Katowice, Katowice, Poland.
¹² Emergency Department, University Hospital Zurich, Zurich, Switzerland.
¹³ Cardiovascular Research Institute Basel and Department of Cardiology, University Hospital Basel, University of Basel, Switzerland; GREAT Network, Rome, Italy; Heart Institute (InCor), University of Sao Paulo Medical School, Sao Paulo Brazil.
¹⁴ GREAT Network, Rome, Italy; Emergency Department, Kantonsspital Luzern, Luzern, Switzerland.
¹⁵ Cardiovascular Research Institute Basel and Department of Cardiology, University Hospital Basel, University of Basel, Switzerland; GREAT Network, Rome, Italy. Electronic address: christian.mueller@usb.ch.

PMID: 32164884
DOI: 10.1016/j.jacc.2019.12.065

Abstract

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).

Keywords: 0/1-h algorithm; diagnosis of myocardial infarction; guidelines; high-sensitivity cardiac troponin I; point of care; rule in; rule out.

Publication types

Multicenter Study
Research Support, Non-U.S. Gov't

MeSH terms

Aged
Aged, 80 and over
Biomarkers / blood
Early Diagnosis
Emergency Service, Hospital
Female
Follow-Up Studies
Humans
Male
Middle Aged
Myocardial Infarction / blood*
Myocardial Infarction / diagnosis*
Point-of-Care Systems*
Prospective Studies
Troponin I / blood*

Substances

Biomarkers
Troponin I

Associated data

ClinicalTrials.gov/NCT00470587