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Aiming toWards Evidence baSed inTerpretation of Cardiac biOmarkers in patients pResenting with chest pain using Point of Care Testing (WESTCOR-POC): study design.
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
Point-of-care high-sensitivity troponin assays: advancements, clinical applications, and implementation considerations
High-sensitivity cardiac troponin (hs-cTn) assays have changed the workflow in emergency departments allowing for rapid allocation of patients with high or low risk of non-ST elevation myocardial infarction. Recently, hs-cTn point-of-care testing (POCT) assays have become available. There are significant expectations that this technology will improve patient flow, reduce overcrowding in emergency departments and improve prehospital investigations for acute coronary syndrome. Measurements of hs-cTn by POCT may also have a role in other health care facilities where hs-cTn measurements are useful but currently unavailable or have long turn-around time and may provide backup instruments for central laboratory platforms in smaller laboratories. This review describes the currently available hs-cTn POCT assays and include an update on recently published clinical data. It outlines benefits of using POCT hs-cTn assays including the possibility of more efficient management of patients with symptoms suggestive of acute coronary syndrome. Additionally, we discuss alternative conditions and clinical and practical scenarios where these assays may become useful. Finally, it highlights the broad spectrum of issues that come along with the implementation of POCT, and suggest the scientific data and practical considerations that should be in place before hs-cTn POCT may be successfully implemented into the daily routine