Safety and feasibility of triage and rapid discharge of patients with chest pain from emergency room: a pragmatic, randomised non-inferiority control trial of the European Society of Cardiology (ESC) 0-1 hour pathway vs. conventional 0-3 hour accelerated diagnostic protocol.

Patients presenting with chest pain represent a significant proportion of Emergency Department (ED) attendances but only a minority, typically 10%, have a final diagnosis of myocardial infarction (MI). Prompt discharge of patients without MI will alleviate ED overcrowding as well as improve patient satisfaction and reduce exposure to risk of hospital acquired infections such as Covid 19. The measurement of cardiac troponin (cTn) by a high sensitivity method is recommended by the National Institute for health and Care Excellence (NICE) for rapid categorisation of patients presenting with chest pain. Strategies proposed include measurement on admission and one hour from admission (ESC 0-1-hour pathway, the recent guideline approved pathway which has not been implemented widely), and measurement on admission and three hours from admission (0-3-hour pathway, which is conventional and widely adopted). The primary objective of this study is twofold: firstly, to assess the safety, feasibility, and impact of implementing the ESC (European Society of Cardiology) 0-1-hour pathway in clinical practice by reference to the more established ESC 0-3-hour protocol. The principal outcome measure will be the safety of the ESC 0-1-hour protocol. However, there are concerns that the time from sample draw to result availability (typically around 60 minutes) will impact on the feasibility of the ESC 0-1-hour pathway. Secondly, therefore, our goal is to evaluate whether measurement of high sensitivity troponin by a bedside analyser (point of care testing, POCT), which will produce results in 15 minutes is a feasible alternative to laboratory testing. We will compare the results produced by POCT with the laboratory results in the context of the ESC 0-1 hour and 0-3-hour pathway, as a nested controlled study in the context of a randomised controlled trial. (clinicaltrials.gov: NCT05322395).

Informations de copyright

Copyright © 2024. Published by Elsevier Inc.

Déclaration de conflit d'intérêts

Conflict of interest Dr A Khand has been a Speaker or expert member and has received fees from the following companies: Bayer, Daiichi Sankyo, Astra Zeneca, Menarini, St Jude, Abbot Vascular. Dr A Khand has received research funds from the following companies: Bayer medical, Menarini, Dragons Den awards (Liverpool University hospitals). Dr A Khand holds research contracts with Abbott Diagnostics. Dr A Khand is the director for Northwest Educational Cardiac Group (nwecg), a not for profit medical educational group and has received sponsorship for educational courses from Bayer, Astra Zeneca, Genzyme (Sanofi), Daiichi Sankyo, Circle Cardiovascular, Menarini, Circle. Dr A Khand works with the Northwest coast Innovation agency in England, is a clinical Champion for high sensitive troponins with funds awarded (both personal payment for work and transformation funding) for dissemination of accelerated diagnostic pathways. P.O. Collinson, Associate Editor of The Journal of Applied Laboratory Medicine, ADLM; received honoraria for lectures from Siemens Healthineers; on the advisory board of Psyros Diagnostics and Radiometer and has previously advised Siemens Healthineers and LumiraDx; consultant to IFCC Committee on Clinical Applications of Cardiac Bio-Markers (C-CB) (unpaid).