Acute Coronary Syndrome
Conditions
Brief summary
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
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.
Interventions
DIAGNOSTIC_TESTTroponin I (Siemens VTli) 0/1 hour algorithm
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.
DIAGNOSTIC_TESTTroponin T (Roche Diagnostics) 0/1 hour ESC algorithm
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.
Sponsors
Siemens Corporation, Corporate Technology
Haukeland University Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Patients \> 17 years who are referred to the Emergency Department of Haukeland University Hospital with chest pain suspect of ACS
Exclusion criteria
1. STEMI (ECG criteria) 2. Patients without STEMI who are immediately transferred to cardiac catheterisation lab (due to heart failure, arrhythmia etc.) without possibility for blood sampling 3. Patients admitted from Nursing homes 4. Patients transferred from other hospitals (e.g. for PCI treatment) 5. Less than 2 months life expectancy from comorbid clinical conditions 6. Not possible to provide informed consent due to cognitive impairment, language problems or other reasons
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Length of stay in the Emergency Department (ED) | Up to 24 hours | Difference in length of stay in the ED will be compared between the two arms |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Discharge rate at 3 hours | 3 hours | Percentages of patients who are discharged within 3 hours will be compared between the two arms |
| Discharge rate at 6 hours | 6 hours | Percentages of patients who are discharged within 6 hours will be compared between the two arms |
| Total length of stay | Up to 3 months | Time from arrival in the ED to discharge from hospital (hours) will be compared between the two arms |
| Composite of myocardial infarction and death | 30 days | Differences in composite of death, myocardial infarction and acute revascularization within 30 days will be compared between the two arms. |
| Composite of myocardial infarction, death and revascularization | 30 days | Death, myocardial infarction or acute revascularization within 12 months after inclusion will be compared between the two arms |
| 12 months costs | 12 months | Costs related to all hospital contacts during 12 months follow-up |
| Patients quality of life according to RAND-12 | 30 days | Patients quality of life will be measured 30 days after discharge using RAND-12 questionnaire and compared between the two arms. |
| Symptom burden | 30 days | Patients quality of life will be measured 30 days after discharge using SAQ7 questionnaire and compared between the two arms |
| Patient satisfaction | 30 days | 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 |
| Total patient episode costs | Up to 3 months | Total patient episode costs will be calculated and compared between the two arms |
Other
| Measure | Time frame | Description |
|---|---|---|
| Re-admission | 30 days | Readmission of any cause within 30 days after inclusion |
Countries
Norway
Outcome results
None listed