Prehospital Triage of Patients With Suspected Non-ST-segment Elevation Acute Coronary Syndrome: the TRIAGE-ACS Study

Study Overview
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Brief Summary
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With the Emergency Medical Services (EMS), no prehospital risk stratification and triage is performed for patients suspected of having an Non-ST-segment elevation Acute Coronary Syndrome (NSTE-ACS). While the latest ESC Guidelines recommend an early invasive strategy within 24 hours for all high risk NSTE-ACS patients and same-day transfer to a PCI (Percutaneous Coronary Intervention) center. With the potential emerging logistical problem surrounding this, prehospital risk stratification and triage can have great benefits in this population as well, especially in patients with a high risk of having an NSTE-ACS. The recently validated PreHEART score makes it possible to stratify patients in a low-risk and high-risk group for having a NSTE-ACS and gives the EMS the opportunity to make triage decisions in the prehospital setting. Patients with a high risk for having an NSTE-ACS are transferred directly to an PCI-center for further diagnostic work-up. Patients with a low risk for having NSTE-ACS and transferred to the ED of the nearest hospital without PCI facilities (non-PCI center) for further diagnostic work-up, resulting in an optimization of the regional care utilization. This is the first study to focus on patients who are at a high risk of having an NSTE-ACS and to assess if whether prehospital triage using the PreHEART score is able to significantly reduce time to final invasive diagnostics and revascularization in patients in need of coronary revascularization.

Official Title
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Prehospital Triage of Patients With Suspected Non-ST-segment Elevation Acute Coronary Syndrome: the TRIAGE-ACS Study

Conditions
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ACS, NSTEMI - Non-ST Segment Elevation MI, Unstable Angina

Intervention / Treatment
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* Diagnostic Test: PreHEART


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Chest pain suspected for NSTE-ACS Age ≥ 18 years Intention to transfer patient to Emergency Department Exclusion Criteria: ST-segment elevation Acute Coronary Syndrome Post resuscitation patients Hemodynamic instability defined as Killip Class IV Suspected other life treating pathology Pregnancy No informed consent for data usage

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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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Cohort 1 (reference group)<br>500 patients will be included as an observatory control group and as a reference group to the second cohort. The PreHEART score is calculated without further consequences for triage in the ambulance and are transferred to the ED of the nearest hospital for standard care. | |
| Cohort 2 (intervention group)<br>500 patients will be included in the interventional cohort. The calculated PreHEART score has consequences for triage in the ambulance. If the PreHEART score is ≥ 5, the patient is classified as a high-risk patient for having NSTE-ACS. These patients are immediately transferred to the ED of the nearest PCI center for further diagnostic examination and to rule out other life-threatening pathologies. When the PreHEART score is ≤ 4, the patient is classified as a low-risk patient for having NSTE-ACS and is transferred to the ED of the nearest hospital without PCI facilities (non-PCI center) for further diagnostic work-up | Diagnostic Test: PreHEART<br>* The PreHEART score is validated for use in the pre-hospital setting.The score can be calculated based on five different elements: history, ECG, age, gender, and a Point-of-Care (POC)-Troponin. A minimum of 0 points and a maximum of 2 points can be scored in each element, the total PreHEART can contain a maximum of 10 points. The score of the history is based on the symptoms of the patient in accordance with the symptoms of a myocardial infarction. Based on the suspicion of ischemia on the ECG. Age will be based on the date of birth. Compared to the female gender, the male gender has higher risk of developing myocardial infarction and will be scored higher. The biomarker Troponin will be collected via intravenous access and measured using a POC-analyzer I-Stat from Abbott industries. In total 17 µl of blood is required to fill a cardiac Troponin I (cTnI) cartridge. Analyzing the blood will take approximately 10 minutes.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time from first medical contact to final invasive diagnostics and revascularization | Duration of time from first medical contact (in the EMS) to final invasive diagnostics and revascularization | Time from first medical contact by EMS to final invasive diagnostics and revascularization, up to 60 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of participants with ischemic complications | Refractory ischemia, new myocardial infarction | 2 years | 
| Logistics during hospitalization | Time from first medical contact to invasive diagnostics Time from invasive diagnostics to revascularization Time from first medical contact to revascularization Duration of hospital admission Number of invasive procedures Numbers of transfers between hospitals by EMS services | 30 days | 
| Number of participants with Major Adverse Cardiac Events | All cause death Myocardial infarction Revascularization Stroke | 7 and 30 days | 
| Number of participants who suffer all cause death | Death from any cause | 1 and 2 years | 
| Number of participants with safety endpoints during invasive diagnostics and/or revascularization | Bleeding complications Contrast-induced nefropathy Possible or definite stent thrombosis Ischemic stroke Death | During hospitalization, up to 60 days | 
| Economic endpoints | Total costs per patient stratified to low- and high-risk groups | During hospitalization, up to 60 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Prehospital, Risk stratification, Triage, Emergency Medical Services