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

NCT ID: NCT02116426

Last Updated: 2018-01-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

320 participants

Study Classification

OBSERVATIONAL

Study Start Date

2015-07-29

Study Completion Date

2017-08-01

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.

Conditions

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Chest Pain

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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The 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.

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

Blood work in the ambulance

Intervention Type BIOLOGICAL

Blood sample for copeptin and troponin HS testing is taken during ambulance care.

Blood work upon arrival in the emergency room

Intervention Type BIOLOGICAL

Blood in drawn for copeptin and troponin HS testing upon arrival in the emergency room.

Blood work at 3 hours post-arrival in the emergency room

Intervention Type BIOLOGICAL

Blood is drawn for troponin HS testing 3 hours after the patient's arrival in the emergency room.

Interventions

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Blood work in the ambulance

Blood sample for copeptin and troponin HS testing is taken during ambulance care.

Intervention Type BIOLOGICAL

Blood work upon arrival in the emergency room

Blood in drawn for copeptin and troponin HS testing upon arrival in the emergency room.

Intervention Type BIOLOGICAL

Blood work at 3 hours post-arrival in the emergency room

Blood is drawn for troponin HS testing 3 hours after the patient's arrival in the emergency room.

Intervention Type BIOLOGICAL

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Centre Hospitalier Universitaire de Nīmes

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Pierre-Géraud Claret, MD

Role: PRINCIPAL_INVESTIGATOR

Centre Hospitalier Universitaire de Nîmes

Locations

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CHRU de Montpellier - Hôpital Lapeyronie

Montpellier, , France

Site Status

CHRU de Nîmes - Hôpital Universitaire Carémeau

Nîmes, , France

Site Status

Countries

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France

Other Identifiers

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2013-A01201-44

Identifier Type: OTHER

Identifier Source: secondary_id

LOCAL/2013/PGC-01

Identifier Type: -

Identifier Source: org_study_id

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