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NCT Number: NCT02116426

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+.

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Key information

Conditions

Chest Pain Diabetes Insipidus Endocrine System Diseases Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Kidney Diseases Male Urogenital Diseases Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Pituitary Diseases Signs and Symptoms Urogenital Diseases Urologic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

CHRU de Montpellier - Hôpital Lapeyronie, Montpellier, France

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Blood work in the ambulance

Biological

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

Blood work upon arrival in the emergency room

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

Biological

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

Primary outcomes

  1. Blood troponin HS concentration (µg/L)

    Time frame: Day 0, in the ambulance

  2. Blood copeptin concentration (pmol/l)

    Time frame: Day 0, in the ambulance

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

    Time frame: Day 28

Secondary outcomes

  1. Blood troponin HS concentration (µg/L)

    Time frame: Day 0, upon arrival in the emergency department

  2. Blood troponin HS concentration (µg/L)

    Time frame: Day 0, 3 hours after arrival in the emergency department

  3. Mortality

    Time frame: Day 28

  4. 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.

  5. Hospital costs (€) associated with avoidable services

    Time frame: Day 28

  6. Distance (km) between the hospital and the patient's place of residence

    Time frame: Day 28

  7. Time spent by ambulance staff at the patient's place of residence

    Time frame: Day 0

  8. Presence/absence of another diagnosis

    Time frame: Day 28

  9. Number of patients taken in charge that day by ambulance staff.

    Time frame: Day 0

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire de Nīmes

Other

Registry information

Official study title

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

Acronym: SCA COP

Important dates

Study start
2015
Primary completion
2017
Study completion
2017
First posted
Apr 16, 2014
Registry last updated
Jan 3, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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