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

January 2, 2018 updated by: Centre Hospitalier Universitaire de Nīmes

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

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+.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Actual)

320

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Montpellier, France, 34295
        • CHRU de Montpellier - Hôpital Lapeyronie
      • Nîmes Cedex 09, France, 30029
        • CHRU de Nîmes - Hôpital Universitaire Carémeau

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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
Biological: Blood work in the ambulance
Blood sample for copeptin and troponin HS testing is taken during ambulance care.
Biological: Blood work upon arrival in the emergency room
Blood in drawn for copeptin and troponin HS testing upon arrival in the emergency room.
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.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Centre Hospitalier Universitaire de Nīmes

Investigators

  • Principal Investigator: Pierre-Géraud Claret, MD, Centre Hospitalier Universitaire de Nîmes

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 29, 2015

Primary Completion (Actual)

August 1, 2017

Study Completion (Actual)

August 1, 2017

Study Registration Dates

First Submitted

April 15, 2014

First Submitted That Met QC Criteria

April 15, 2014

First Posted (Estimate)

April 16, 2014

Study Record Updates

Last Update Posted (Actual)

January 3, 2018

Last Update Submitted That Met QC Criteria

January 2, 2018

Last Verified

January 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • LOCAL/2013/PGC-01
  • 2013-A01201-44 (Other Identifier: RCB number:)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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