The aim of the current study is to perform a RCT comparing safety and efficiency of a standard care (in-line with current ESC recommendations) to an algorithm that utilize a POC troponin tests for bedside measurement, the instruments could be located in the ED and return results in few minutes.
Ischemic coronary artery disease is an important health challenge and a common cause of death worldwide. Patients with symptoms suggestive of acute coronary syndrome are frequently referred to the emergency department (ED) and impose a high work-load on hospitals. Since 2009, high-sensitivity cardiac troponin (hs-cTn) assays have become a crucial ED tool for differentiating between patients with and without Non-ST-elevation myocardial infarction (NSTEMI). Accordingly, the European Society of Cardiology (ESC) recommends 0-1 hour algorithms that use hs-cTn for rule-out and rule-in of NSTEMI. Additionally, the clinical suspicion of acute coronary syndrome (ACS) or other life-threating conditions must be low. Unfortunately, these algorithms have been difficult to implement into routine and clinical practice, and are only used by a limited number of hospitals due to lack of randomized clinical trials and practical obstacles, including turnaround time for troponins. The aim of the current study is to perform a RCT comparing safety and efficiency of a standard care (in-line with current ESC recommendations) to an algorithm that utilize a POC troponin tests for bedside measurement, the instruments could be located in the ED and return results in few minutes.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
NONE
Enrollment
1,496
Patients will be investigated using the ESC 0/1 hour cTnT algorithm from ESC compared to a 0/1 hour algorithm utilizing the Siemens VTli POC instrument for cTnI.
Patients will be investigated using the ESC 0/1 hour cTnT algorithm from ESC compared to a 0/1 hour algorithm utilizing the Siemens VTli POC instrument for cTnI.
Haukeland University Hospital
Bergen, Norway
Length of stay in the Emergency Department (ED)
Difference in length of stay in the ED will be compared between the two arms
Time frame: Up to 24 hours
Discharge rate at 3 hours
Percentages of patients who are discharged within 3 hours will be compared between the two arms
Time frame: 3 hours
Discharge rate at 6 hours
Percentages of patients who are discharged within 6 hours will be compared between the two arms
Time frame: 6 hours
Total length of stay
Time from arrival in the ED to discharge from hospital (hours) will be compared between the two arms
Time frame: Up to 3 months
Composite of myocardial infarction and death
Differences in composite of death, myocardial infarction and acute revascularization within 30 days will be compared between the two arms.
Time frame: 30 days
Composite of myocardial infarction, death and revascularization
Death, myocardial infarction or acute revascularization within 12 months after inclusion will be compared between the two arms
Time frame: 30 days
Composite of myocardial infarction and death
Differences in composite of death, myocardial infarction and acute revascularization within 30 days will be compared between the two arms.
Time frame: 1 year
Composite of myocardial infarction, death and revascularization
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Death, myocardial infarction or acute revascularization within 12 months after inclusion will be compared between the two arms
Time frame: 1 year
Total patient episode costs
Total patient episode costs will be calculated and compared between the two arms
Time frame: Up to 3 months
12 months costs
Costs related to all hospital contacts during 12 months follow-up
Time frame: 12 months
Patients quality of life according to RAND-12
Patients quality of life will be measured 30 days after discharge using RAND-12 questionnaire and compared between the two arms.
Time frame: 30 days
Symptom burden
Patients quality of life will be measured 30 days after discharge using SAQ7 questionnaire and compared between the two arms
Time frame: 30 days
Patient satisfaction
Change in patients satisfaction with the hospital admission/contact will be measured 30 days after discharge using PasOP14 questionnaire and compared between the two arms
Time frame: 30 days