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A randomized trial of a 1-hour troponin T protocol in suspected acute coronary syndromes: Design of the Rapid Assessment of Possible ACS In the emergency Department with high sensitivity Troponin T (RAPID-TnT) study - 01/08/17

Doi : 10.1016/j.ahj.2017.05.004 
Cynthia Papendick a, Andrew Blyth c, Anil Seshadri b, c, Michael J.R. Edmonds c, Tom Briffa d, Louise Cullen e, f, g, Stephen Quinn h, Jon Karnon a, Anthony Chuang b, c, Adam J. Nelson a, Matthew Horsfall c, Erin Morton b, Derek P. Chew b, c,
a School of Medicine, University of Adelaide, Adelaide, Australia 
b School of Medicine, Flinders University of South Australia, Adelaide, Australia 
c South Australian Department of Health, Adelaide, Australia 
d School of Population and Global Health, University of Western Australia, Perth, Australia 
e Department of Emergency Medicine, Royal Brisbane and Women's Hospital, Brisbane, Australia 
f School of Public Health, Queensland University of Technology, Brisbane, Australia 
g School of Medicine, University of Queensland, Brisbane, Australia 
h Department of Statistics, Data Science and Epidemiology, Swinburne University of Technology, Melbourne, Australia 

Reprint requests: Derek P. Chew, MBBS, MPH, Flinders University, Flinders Drive, Bedford Park, South Australia, 5042, Australia.Flinders UniversityFlinders DriveBedford ParkSouth Australia5042Australia

Abstract

Background

Protocols incorporating high-sensitivity troponin to guide decision making in the disposition of patients with suspected acute coronary syndromes (ACS) in the emergency department have received a lot of attention. Traditionally, patients with chest pain have required long periods of observation in emergency department before being deemed safe for discharge. In an era of limited health service resources, a protocol that could discharge patients safely within an hour of presentation is extremely attractive. Unfortunately, despite incorporation into some guidelines, these protocols have not been subjected to randomized comparisons evaluating safety, effectiveness, and cost-effectiveness.

Objective

This study is designed to provide the evidence required to allow key decision makers to implement these protocols: specifically, to provide evidence that a decision rule based on 0- and 1-hour high-sensitivity troponin T (hs-TnT) is safe, provides noninferior outcomes in all patients with suspected ACS, and that implementation of a rapid troponin protocol leads to efficient care.

Design

This prospective pragmatic trial (n=5,400, 5 hospitals) randomly allocates patients with suspected ACS to either a 0/1-hour hs-TnT protocol as advocated in clinical guidelines, versus usual care of standard troponin reporting evaluated at 3 and 6hours. The primary effectiveness composite end points of this study are all-cause death and new/recurrent ACS within 30days. To evaluate cost-effectiveness, follow-up will determine clinical events, quality of life, and resource utilization within 12 months.

Summary

Demonstrating that a 0/1-hour hs-TnT protocol improves the effectiveness and efficiency of care within a robust comparative study will fill an evidence gap that currently limits the translation of more precise hs-TnT testing into better patient and health service outcomes.

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Plan


 RCT No. ACTRN12615001379505.
 Funding: Support for this study was granted from the National Health and Medical Research Council of Australia (APP1124471) and Roche Diagnostics (Basel, Switzerland). Neither funder has requested any modification of the protocol not access to the data on completion. Funding was sought after the study was designed, approved by the human research ethics committee, and initiated.
 Conflicts of interest: None.


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Vol 190

P. 25-33 - août 2017 Retour au numéro
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