Aiming toWards Evidence baSed inTerpretation of Cardiac biOmarkers in patients pResenting with chest pain using Point of Care Testing (WESTCOR-POC): study design

Abstract

Objectives

Patients presenting with symptoms suggestive of acute coronary syndrome (ACS) contribute to a high workload and overcrowding in the Emergency Department (ED). Accelerated diagnostic protocols for non-ST-elevation myocardial infarction have proved challenging to implement. One obstacle is the turnaround time for analyzing high-sensitivity cardiac troponin (hs-cTn). In the WESTCOR-POC study (Clinical Trials number NCT05354804) we aim to evaluate safety and efficiency of a 0/1 h hs-cTn algorithm utilizing a hs-cTnI point of care (POC) instrument in comparison to central laboratory hs-cTnT measurements.

Design

This is a prospective single-center randomized clinical trial aiming to include 1500 patients admitted to the ED with symptoms suggestive of ACS. Patients will receive standard investigations following the European Society of Cardiology 0/1h protocols for centralized hs-cTnT measurements or the intervention using a 0/1h POC hs-cTnI algorithm. Primary end-points are 1) Safety; death, myocardial infarction or acute revascularization within 30 days 2) Efficiency; length of stay in the ED, 3) Cost- effectiveness; total episode cost, 4) Patient satisfaction, 5) Patient symptom burden and 6) Patients quality of life. Secondary outcomes are 12-months death, myocardial infarction or acute revascularization, percentage discharged after 3 and 6 h, total length of hospital stay and all costs related to hospital contact within 12 months.

Conclusion

Results from this study may facilitate implementation of POC hs-cTn testing assays and accelerated diagnostic protocols in EDs, and may serve as a valuable resource for guiding future investigations for the use of POC high sensitivity troponin assays in outpatient clinics and prehospital settings.

Keywords:

• Chest pain
• nSTEMI
• acute coronary syndrome
• cardiovascular biomarkers
• rule in/rule-out algorithms
• high-sensitivity troponin
• unstable angina pectoris
• point-of-care testing

Disclosure statement

K.M.A. is associate editor of Clinical Biochemistry, chair of the IFCC Committee on Clinical Application of Cardiac Biomarkers, has served on advisory boards for Roche Diagnostics, Siemens Healthineers and SpinChip, received consultant honoraria form CardiNor, lecturing honorarium from Siemens Healthineers and Snibe Diagnostics and research grants from Siemens Healthineers and Roche Diagnostics.

L.C. is the co-chair of the National Heart Foundation and Cardiac Society of Australia and New Zealand Assessment and management of ACS guidelines and has served on advisory boards for Abbott Diagnostics and Siemens Healthineers, received consultant honoraria from Abbott Diagnostics, Beckman Coulter, Radiometer Pacific and Siemens Healthineers. LCs institution has received grants from Abbott Diagnostics, Beckman Coulter, Radiometer Pacific, Roche and Siemens.

P. O. C. is an associate editor of the Journal of Applied Laboratory Medicine and on the advisory board of and has previously advised Psyros Diagnostics, Radiometer, LumiraDx and Siemens Healthineers and has received Honoria for lectures from Siemens.

F.S.A: Consultant: HyTest Ltd, AWE Medical Group; Associate Editor: Clinical Chemistry; Advisory Boards: Werfen, Siemens Healthineers, Qorvo, Abbott Vascular; Honorarium for Speaking at Industry Conferences: Siemens Healthineers, Beckman Coulter; PI on Industry Funded Grants (non-salaried) on cardiac biomarkers through Hennepin Healthcare Research Institute: Abbott Diagnostics, Abbott POC, BD, Beckman Coulter, Ortho-Clinical Diagnostics, Roche Diagnostics, Siemens Healthcare, ET Healthcare, Qorvo.

T.O has received research support from Abbott Diagnostics, ChromaDex, Novartis, and Roche Diagnostics; consulting fees and/or speaker honoraria from Abbott Diagnostics, Bayer, CardiNor, and Roche Diagnostics; and stock and stock options from CardiNor.

I.V.L.T, S.M.F.J, O.C.L, J.K, O.T.S, T.N, TW, K.V, R.O B report no disclosures.

Additional information

Funding

The study is funded by grants from the Western Norway Regional Health Authority, Grant number F-12852-D10484. The instrument and reagent costs will be covered by Siemens Healthineers. The sponsor had no influence on the design of this study, nor on the writing of the manuscript.