Why the study?
Turnaround times for high-sensitivity cardiac troponin analysis hinder the implementation of accelerated diagnostic protocols for non-ST-elevation myocardial infarction in overcrowded Emergency Departments.
Does a 0/1h point of care hs-cTnI algorithm improve efficiency and maintain safety compared to centralized hs-cTnT measurements in patients presenting to the ED with symptoms suggestive of ACS?
Does a 0/1h point of care hs-cTnI algorithm improve efficiency and maintain safety compared to centralized hs-cTnT measurements in patients presenting to the ED with symptoms suggestive of ACS?
The WESTCOR-POC study will evaluate the safety and efficiency of a point-of-care high-sensitivity troponin I algorithm compared to central laboratory testing in ED patients with suspected ACS.
Tests whether POC hs-cTnI safely speeds ED ACS evaluation; RCT extends centralized hs-cTn evidence to point-of-care algorithms.
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.
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Thulin et al. (2023) studied this question.
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