NCT02116426

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+.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
320

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jul 2015

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 15, 2014

Completed
1 day until next milestone

First Posted

Study publicly available on registry

April 16, 2014

Completed
1.3 years until next milestone

Study Start

First participant enrolled

July 29, 2015

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2017

Completed
Last Updated

January 3, 2018

Status Verified

January 1, 2018

Enrollment Period

2 years

First QC Date

April 15, 2014

Last Update Submit

January 2, 2018

Conditions

Chest Pain

Keywords

copeptintroponin HS

Outcome Measures

Primary Outcomes (3)

  • Blood troponin HS concentration (µg/L)

    Day 0, in the ambulance

  • Blood copeptin concentration (pmol/l)

    Day 0, in the ambulance

  • Final diagnosis of ACS non ST + (yes/no)

    Day 28

Secondary Outcomes (9)

  • Blood troponin HS concentration (µg/L)

    Day 0, upon arrival in the emergency department

  • Blood troponin HS concentration (µg/L)

    Day 0, 3 hours after arrival in the emergency department

  • Mortality

    Day 28

  • Would you leave the patient at home if both copeptin and troponin tests were negative?

    Day O (in the ambulance)

  • Hospital costs (€) associated with avoidable services

    Day 28

  • +4 more secondary outcomes

Study Arms (1)

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 ambulanceBiological: Blood work upon arrival in the emergency roomBiological: Blood work at 3 hours post-arrival in the emergency room

Interventions

Blood work in the ambulanceBIOLOGICAL

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

The study population
Blood work upon arrival in the emergency roomBIOLOGICAL

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

The study population
Blood work at 3 hours post-arrival in the emergency roomBIOLOGICAL

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

The study population

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability 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.

You may qualify if:

  • 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

You may not qualify if:

  • The patient is participating in another 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

CHRU de Montpellier - Hôpital Lapeyronie

Montpellier, 34295, France

Location

CHRU de Nîmes - Hôpital Universitaire Carémeau

Nîmes, 30029, France

Location

MeSH Terms

Conditions

Chest PainDiabetes Insipidus

Condition Hierarchy (Ancestors)

PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesPituitary DiseasesEndocrine System Diseases

Study Officials

  • Pierre-Géraud Claret, MD

    Centre Hospitalier Universitaire de Nîmes

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 15, 2014

First Posted

April 16, 2014

Study Start

July 29, 2015

Primary Completion

August 1, 2017

Study Completion

August 1, 2017

Last Updated

January 3, 2018

Record last verified: 2018-01

Locations

FR(2)