Clinical trial NCT02116426: Copeptin Testing During Pre-hospital Care in the Treatment of Chest Pain Suggestive of Acute Coronary Syndrome
Official title: The Role of Copeptin Testing During Pre-hospital Care in the Treatment of Chest Pain Suggestive of Acute Coronary Syndrome
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Chest Pain
Keywords: copeptin
troponin HS
Lead sponsor: Centre Hospitalier Universitaire de Nīmes
Sponsor class: OTHER
First posted: 2014-04-16
Enrollment: 320
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Blood troponin HS concentration (µg/L)
timeFrame: Day 0, in the ambulance
measure: Blood copeptin concentration (pmol/l)
timeFrame: Day 0, in the ambulance
measure: Final diagnosis of ACS non ST + (yes/no)
timeFrame: Day 28
Secondary outcomes:
measure: Blood troponin HS concentration (µg/L)
timeFrame: Day 0, upon arrival in the emergency department
measure: Blood troponin HS concentration (µg/L)
timeFrame: Day 0, 3 hours after arrival in the emergency department
measure: Mortality
timeFrame: Day 28
measure: Would you leave the patient at home if both copeptin and troponin tests were negative?
timeFrame: Day O (in the ambulance)
measure: Hospital costs (€) associated with avoidable services
timeFrame: Day 28
measure: Distance (km) between the hospital and the patient's place of residence
timeFrame: Day 28
measure: Time spent by ambulance staff at the patient's place of residence
timeFrame: Day 0
measure: Presence/absence of another diagnosis
timeFrame: Day 28
measure: Number of patients taken in charge that day by ambulance staff.
timeFrame: Day 0
Other outcomes:
Locations:
city: Montpellier
country: France
facility: CHRU de Montpellier - Hôpital Lapeyronie
city: Nîmes Cedex 09
country: France
facility: CHRU de Nîmes - Hôpital Universitaire Carémeau
Study officials:
affiliation: Centre Hospitalier Universitaire de Nîmes
name: Pierre-Géraud Claret, MD
role: PRINCIPAL_INVESTIGATOR
References: