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

Completed

• Conditions: Chest Pain
• Interventions: 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

• Registration Number: NCT02116426
• Lead Sponsor: Centre Hospitalier Universitaire de Nīmes

Brief Summary

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

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.

Study Timeline

• Study First Submitted: 2014-04-15
• Study First Submitted QC: 2014-04-15
• Study First Posted: 2014-04-16
• Study Start: 2015-07-29
• Primary Completion: 2017-08-01
• Study Completion: 2017-08-01
• Status Verified: 2018-01
• Last Update Submitted: 2018-01-02
• Last Update Posted: 2018-01-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 320

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
The study population	Blood work upon arrival in the emergency room	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
The study population	Blood work at 3 hours post-arrival in the emergency room	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
The study population	Blood work in the ambulance	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

Primary Outcome Measures

Name	Time	Method
Blood copeptin concentration (pmol/l)	Day 0, in the ambulance
Final diagnosis of ACS non ST + (yes/no)	Day 28
Blood troponin HS concentration (µg/L)	Day 0, in the ambulance

Secondary Outcome Measures

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

Trial Locations

Locations (2)

CHRU de Nîmes - Hôpital Universitaire Carémeau; 🇫🇷 Nîmes Cedex 09, France

CHRU de Montpellier - Hôpital Lapeyronie; 🇫🇷 Montpellier, France