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

Chest Pain Clinical Trial

— SCA COP  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02116426
• Other study ID #: LOCAL/2013/PGC-01
• Secondary ID: 2013-A01201-44
• Status: Completed
• Phase: N/A
• First received: April 15, 2014
• Last updated: January 2, 2018
• Start date: July 29, 2015
• Est. completion date: August 1, 2017

Study information

• Verified date: January 2018
• Source: Centre Hospitalier Universitaire de Nimes
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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+.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 320
• Est. completion date: August 1, 2017
• Est. primary completion date: August 1, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Acute Coronary Syndrome
• Chest Pain
• Diabetes Insipidus

Intervention

Biological:
• Blood work in the ambulance
Blood sample for copeptin and troponin HS testing is taken during ambulance care.
• Blood work upon arrival in the emergency room
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
Blood is drawn for troponin HS testing 3 hours after the patient's arrival in the emergency room.

Locations

Country	Name	City	State
France	CHRU de Montpellier - Hôpital Lapeyronie	Montpellier
France	CHRU de Nîmes - Hôpital Universitaire Carémeau	Nîmes Cedex 09

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire de Nimes

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Blood troponin HS concentration (µg/L)		Day 0, in the ambulance
Primary	Blood copeptin concentration (pmol/l)		Day 0, in the ambulance
Primary	Final diagnosis of ACS non ST + (yes/no)		Day 28
Secondary	Blood troponin HS concentration (µg/L)		Day 0, upon arrival in the emergency department
Secondary	Blood troponin HS concentration (µg/L)		Day 0, 3 hours after arrival in the emergency department
Secondary	Mortality		Day 28
Secondary	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)
Secondary	Hospital costs (€) associated with avoidable services		Day 28
Secondary	Distance (km) between the hospital and the patient's place of residence		Day 28
Secondary	Time spent by ambulance staff at the patient's place of residence		Day 0
Secondary	Presence/absence of another diagnosis		Day 28
Secondary	Number of patients taken in charge that day by ambulance staff.		Day 0