Abstract
Background: It is not yet investigated whether referral decisions based on prehospital risk stratification of non-ST-elevation Acute Coronary Syndrome (NSTE-ACS) by the complete History, ECG, Age, Risk factors and initial Troponin (HEART) score are feasible and safe. Hypothesis: Implementation of referral decisions based on the prehospital acquired HEART score in patients with suspected NSTE-ACS is feasible and not inferior to routine management in the occurrence of major adverse cardiac events within 45 days. Study design & methods: FamouS Triage 3 is a feasibility study with a before–after sequential design. The aim is to assess whether prehospital HEART-score management including point-of-care troponin measurement is feasible and noninferior to routine management. Primary end point is the occurrence of major adverse cardiac events within 45 days. Conclusion: If referral decisions based on prehospital acquired risk stratification are feasible and noninferior this can become the new prehospital management in suspected NSTE-ACS.
Author contributions
All authors contributed to the conception or design of the work, the acquisition and analysis. All authors were involved in drafting and commenting on the paper and have approved the final version.
Acknowledgments
The authors thank R Brohet for advice on statistical analyses and sample size calculation and we thank T Hosman for language editing and proofreading.
Financial & competing interests disclosure
This work was supported by Isala Research Fund (Grant number INNO1326). Roche Diagnostics provided POC devices and POC strips. Researchers were independent of funders and funders were not involved in writing this research or performing analyses. The authors have no other relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript apart from those disclosed.
No writing assistance was utilized in the production of this manuscript.
Transparency declaration
The lead author affirms that this manuscript is an honest, accurate and transparent account of the study being reported; that no important aspects of the study have been omitted; and that any discrepancies from the study as planned have been explained.
Ethical conduct of research
The authors state that they have obtained appropriate Institutional Review Board approval or have followed the principles outlined in the Declaration of Helsinki for all human or animal experimental investigations. In addition, for investigations involving human subjects, informed consent has been obtained from the participants involved. The study was approved by the Institutional Review Board (medical ethical committee of the Isala Clinics, Zwolle, The Netherlands, METC no. 170526), and subsequently by the boards of the participating hospitals.
Trial registration
Netherlands trial register: NTR7070.