Aiming Towards Evidence Based Interpretation of Cardiac Biomarkers in Patients Presenting With Chest Pain Using Point of Care Assays

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Aiming Towards Evidence Based Interpretation of Cardiac Biomarkers in Patients Presenting With Chest Pain Using Point of Care Assays

Conditions
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Acute Coronary Syndrome

Intervention / Treatment
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* Diagnostic Test: Troponin I (Siemens VTli) 0/1 hour algorithm
* Diagnostic Test: Troponin T (Roche Diagnostics) 0/1 hour ESC algorithm


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients > 17 years who are referred to the Emergency Department of Haukeland University Hospital with chest pain suspect of ACS Exclusion Criteria: STEMI (ECG criteria) Patients without STEMI who are immediately transferred to cardiac catheterisation lab (due to heart failure, arrhythmia etc.) without possibility for blood sampling Patients admitted from Nursing homes Patients transferred from other hospitals (e.g. for PCI treatment) Less than 2 months life expectancy from comorbid clinical conditions Not possible to provide informed consent due to cognitive impairment, language problems or other reasons

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Standard<br>Patients randomized to standard care will be sampled at admission and after 1 hour (and furthermore as clinically indicated). High sensitive Troponin T (cTnT) and standard laboratory tests will be measured in the central hospital laboratory using Cobas e801 from Roche Diagnostics and eligibility for rule-out will be judged in accordance with the ESC 0/1 hour rule-out algorithm for cTnT. ECG and HEART-score will be obtained in all patients, other clinical investigations will be ordered by the attending physician. If NSTE-ACS is low risk based on the cTnT algorithm, HEART< 4 and non-ischemic ECG, patients will be investigated according to the ED flow chart for non-coronary acute chest pain, in order to identify differential diagnoses. Patients will be admitted or discharged based on the clinical judgement of the attending physician. | Diagnostic Test: Troponin T (Roche Diagnostics) 0/1 hour ESC algorithm<br>* 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.<br>|
| Active Comparator: POC<br>Blood samples will be obtained at admission, standard blood tests will be measured at the central laboratory whilst high sensitive troponin I at 0 and 1 hour will be analyzed using a POC instrument from Siemens Healthineers in the ED. ECG and HEART-score will be obtained in all patients, other clinical investigations will be ordered by the attending physician. If the cTnI concentration at admission and the 1-hour delta is below a pre-specified concentration, the HEART- score < 4, and the ECG is non-ischemic the patients will be allocated to the rule-out of NSTEMI group and investigated according to the ED flow chart for non-coronary acute chest pain, in order to identify differential diagnosis. Finally, patients will be admitted or discharged based on the clinical judgement of the attending physician. | Diagnostic Test: Troponin I (Siemens VTli) 0/1 hour algorithm<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Composite of myocardial infarction, death and revascularization | Differences in composite of death, myocardial infarction and acute revascularization within 30 days will be compared between the two arms. | 30 days | 
| Length of stay in the Emergency Department (ED) | Difference in length of stay in the ED will be compared between the two arms | Up to 24 hours | 
| 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. | 30 days | 
| Symptom burden | Patients quality of life will be measured 30 days after discharge using SAQ7 questionnaire and compared between the two arms | 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 | 30 days | 
| Total patient episode costs | Total patient episode costs will be calculated and compared between the two arms | Up to 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 1 year | 
| Discharge rate at 3 hours | Percentages of patients who are discharged within 3 hours will be compared between the two arms | 3 hours | 
| Discharge rate at 6 hours | Percentages of patients who are discharged within 6 hours will be compared between the two arms | 6 hours | 
| Total length of stay | Time from arrival in the ED to discharge from hospital (hours) will be compared between the two arms | Up to 3 months | 
| 12 months costs | Costs related to all hospital contacts during 12 months follow-up | 12 months |