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| Name | Class |
|---|---|
| Siemens Corporation, Corporate Technology | INDUSTRY |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Standard | Placebo Comparator | 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. |
|
| POC | Active Comparator | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Troponin I (Siemens VTli) 0/1 hour algorithm | Diagnostic Test | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Re-admission | Readmission of any cause within 30 days after inclusion | 30 days |
Inclusion Criteria:
Patients > 17 years who are referred to the Emergency Department of Haukeland University Hospital with chest pain suspect of ACS
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Kristin M Aakre, MD/PhD | Haukeland University Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Haukeland University Hospital | Bergen | 5020 | Norway |
We do not plan to share individual participant data.
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| Troponin T (Roche Diagnostics) 0/1 hour ESC algorithm | Diagnostic Test | 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. |
|
| 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 |
| 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. | 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 | 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. | 1 year |
| 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 |
| Total patient episode costs | Total patient episode costs will be calculated and 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 |
| 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 |
| ID | Term |
|---|---|
| D054058 | Acute Coronary Syndrome |
| ID | Term |
|---|---|
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D014652 | Vascular Diseases |
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| ID | Term |
|---|---|
| D000465 | Algorithms |
| ID | Term |
|---|---|
| D055641 | Mathematical Concepts |
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