Copeptin Testing During Pre-hospital Care in the Treatment of Chest Pain Suggestive of Acute Coronary Syndrome

Study Overview
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Brief Summary
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The main objective of our study is to evaluate the diagnostic value of copeptin testing in association with troponin HS testing during pre-hospital care (ambulance care) in the treatment of patients whose pattern of use is the occurrence chest pain suggestive of ACS but not ST+.

Detailed Description
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The secondary objectives of this study are to: A. Evaluate the diagnostic value of determination of copeptin testing in pre-hospital care in another diagnosis; B. Assess the prognostic value of copeptin assay on vital prognosis at day 28; C. Evaluate the kinetics of copeptin and troponin HS between initial ambulance care and arrival at the emergency department; D. Evaluate the potential impact of copeptin testing on pre-hospital patient care; E. Assess the economic impact of pre-hospital copeptin testing in terms of hospital stays and optimizing ambulance movements.

Official Title
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The Role of Copeptin Testing During Pre-hospital Care in the Treatment of Chest Pain Suggestive of Acute Coronary Syndrome

Conditions
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Chest Pain

Intervention / Treatment
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* Biological: Blood work in the ambulance
* Biological: Blood work upon arrival in the emergency room
* Biological: Blood work at 3 hours post-arrival in the emergency room


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: all major adult patients taken in charge by the emergency ambulance services of the participating centers for non-traumatic chest pain for suspected ACS and an electrocardiogram initially excluding an ST segment elevation Exclusion Criteria: The patient is participating in another study The patient is in an exclusion period determined by a previous study The patient is under judicial protection, under tutorship or curatorship The patient (or a legal representative) formalizes his/her opposition for the study It is impossible to correctly inform the patient The patient is pregnant, parturient, or breastfeeding The patient has a contraindication for a treatment used in this study The patient's initial electrocardiogram indicates an ST segment elevation

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 |
| --- | --- |
| The study population<br>The study population includes all adult patients taken in charge by the emergency ambulance services of the participating centers for non-traumatic chest pain for suspected Acute Coronary Syndrome (ACS) without ST segment elevation. Intervention: Blood work in the ambulance Intervention: Blood work upon arrival in the emergency room Intervention: Blood work at 3 hours post-arrival in the emergency room | Biological: Blood work in the ambulance<br>* Blood sample for copeptin and troponin HS testing is taken during ambulance care.<br>Biological: Blood work upon arrival in the emergency room<br>* Blood in drawn for copeptin and troponin HS testing upon arrival in the emergency room.<br>Biological: Blood work at 3 hours post-arrival in the emergency room<br>* Blood is drawn for troponin HS testing 3 hours after the patient's arrival in the emergency room.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Blood troponin HS concentration (µg/L) |  | Day 0, in the ambulance | 
| Blood copeptin concentration (pmol/l) |  | Day 0, in the ambulance | 
| Final diagnosis of ACS non ST + (yes/no) |  | Day 28 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Blood troponin HS concentration (µg/L) |  | Day 0, upon arrival in the emergency department | 
| Blood troponin HS concentration (µg/L) |  | Day 0, 3 hours after arrival in the emergency department | 
| Mortality |  | Day 28 | 
| Would you leave the patient at home if both copeptin and troponin tests were negative? | Yes/no question asked of ambulance doctors. | Day O (in the ambulance) | 
| Hospital costs (€) associated with avoidable services |  | Day 28 | 
| Distance (km) between the hospital and the patient's place of residence |  | Day 28 | 
| Time spent by ambulance staff at the patient's place of residence |  | Day 0 | 
| Presence/absence of another diagnosis |  | Day 28 | 
| Number of patients taken in charge that day by ambulance staff. |  | Day 0 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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copeptin, troponin HS