Chest PainSCA COPNCT02116426
Copeptin Testing During Pre-hospital Care in the Treatment of Chest Pain Suggestive of Acute Coronary Syndrome
An observational study of Chest Pain, run by Centre Hospitalier Universitaire de Nīmes at 2 sites in France.
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+. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chest Pain
- What is being tested?
- Blood work in the ambulance, Blood work upon arrival in the emergency room and Blood work at 3 hours post-arrival in the emergency room
- How many people
- 320 participants
- Where
- 2 sitesFrance
- Study dates
- 29 Jul 2015to 1 Aug 2017
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country.
France2 sites
CHRU de Montpellier - Hôpital Lapeyronie
Montpellier, 34295
CHRU de Nîmes - Hôpital Universitaire Carémeau
Nîmes, 30029
About this study
Official title: 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+.
Read the detailed description
The secondary objectives of this study are to:
- Evaluate the diagnostic value of determination of copeptin testing in pre-hospital care in another diagnosis;
- Assess the prognostic value of copeptin assay on vital prognosis at day 28;
- Evaluate the kinetics of copeptin and troponin HS between initial ambulance care and arrival at the emergency department;
- Evaluate the potential impact of copeptin testing on pre-hospital patient care;
- Assess the economic impact of pre-hospital copeptin testing in terms of hospital stays and optimizing ambulance movements.
- Conditions
- Chest Pain
- Being tested
- Blood work in the ambulance, Blood work upon arrival in the emergency room, Blood work at 3 hours post-arrival in the emergency room
- Keywords
- copeptin, troponin HS
- Medical subject headings
- Chest Pain, Diabetes Insipidus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood work in the ambulanceBiological
Blood sample for copeptin and troponin HS testing is taken during ambulance care.
Blood work upon arrival in the emergency roomBiological
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 roomBiological
Blood is drawn for troponin HS testing 3 hours after the patient's arrival in the emergency room.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Biological: Blood work in the ambulance; Biological: Blood work upon arrival in the emergency room; Biological: Blood work at 3 hours post-arrival in the emergency room |
What is being measured
The primary outcome is the main question the study is designed to answer.
Blood troponin HS concentration (µg/L)
Measured: Day 0, in the ambulance
Blood copeptin concentration (pmol/l)
Measured: Day 0, in the ambulance
Final diagnosis of ACS non ST + (yes/no)
Measured: Day 28
Secondary outcomes (9)
Blood troponin HS concentration (µg/L)
Measured: Day 0, upon arrival in the emergency department
Blood troponin HS concentration (µg/L)
Measured: Day 0, 3 hours after arrival in the emergency department
Mortality
Measured: Day 28
Would you leave the patient at home if both copeptin and troponin tests were negative?
Yes/no question asked of ambulance doctors.
Measured: Day O (in the ambulance)
Hospital costs (€) associated with avoidable services
Measured: Day 28
Distance (km) between the hospital and the patient's place of residence
Measured: Day 28
Time spent by ambulance staff at the patient's place of residence
Measured: Day 0
Presence/absence of another diagnosis
Measured: Day 28
Number of patients taken in charge that day by ambulance staff.
Measured: Day 0
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Apr 2014 (estimated)
- Study start29 Jul 2015
- Primary completion1 Aug 2017
- Study completion1 Aug 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chest PainStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire de NīmesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 320 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de Nīmes
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Pierre-Géraud Claret, MD, Principal investigator, Centre Hospitalier Universitaire de Nīmes
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02116426
- Sponsor's protocol ID
- LOCAL/2013/PGC-01
- Other IDs
- 2013-A01201-44
- Acronym
- SCA COP
- Status last verified
- Jan 2018
- First submitted
- 15 Apr 2014
- Last updated
- 3 Jan 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Role of Copeptin Testing During Pre-hospital Care in the Treatment of Chest Pain Suggestive of Acute Coronary Syndrome
- ClinicalTrials.gov ID
- NCT02116426
- Acronym / sponsor ID
- SCA COP / LOCAL/2013/PGC-01
- Conditions
- Chest Pain
- Keywords
- copeptin, troponin HS
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 320 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire de NīmesUniversity, hospital or other
- Study start
- 29 Jul 2015 (actual)
- Primary completion
- 1 Aug 2017 (actual)
- Study completion
- 1 Aug 2017 (actual)
- First posted
- 16 Apr 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
The secondary objectives of this study are to:
- Evaluate the diagnostic value of determination of copeptin testing in pre-hospital care in another diagnosis;
- Assess the prognostic value of copeptin assay on vital prognosis at day 28;
- Evaluate the kinetics of copeptin and troponin HS between initial ambulance care and arrival at the emergency department;
- Evaluate the potential impact of copeptin testing on pre-hospital patient care;
- Assess the economic impact of pre-hospital copeptin testing in terms of hospital stays and optimizing ambulance movements.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| The study population | – | Biological: Blood work in the ambulance, Biological: Blood work upon arrival in the emergency room, Biological: Blood work at 3 hours post-arrival in the emergency roomThe 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (1 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Blood work in the ambulanceBlood sample for copeptin and troponin HS testing is taken during ambulance care. | Biological | The study population |
| Blood work upon arrival in the emergency roomBlood in drawn for copeptin and troponin HS testing upon arrival in the emergency room. | Biological | The study population |
| Blood work at 3 hours post-arrival in the emergency roomBlood is drawn for troponin HS testing 3 hours after the patient's arrival in the emergency room. | Biological | The study population |
Primary outcome
Blood troponin HS concentration (µg/L)
Time frame: Day 0, in the ambulance
Blood copeptin concentration (pmol/l)
Time frame: Day 0, in the ambulance
Final diagnosis of ACS non ST + (yes/no)
Time frame: Day 28
9 secondary outcomes
Blood troponin HS concentration (µg/L)
Time frame: 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
Mortality
Time frame: Day 28
Would you leave the patient at home if both copeptin and troponin tests were negative?
Time frame: Day O (in the ambulance)
Hospital costs (€) associated with avoidable services
Time frame: Day 28
Distance (km) between the hospital and the patient's place of residence
Time frame: Day 28
Time spent by ambulance staff at the patient's place of residence
Time frame: Day 0
Presence/absence of another diagnosis
Time frame: Day 28
Number of patients taken in charge that day by ambulance staff.
Time frame: Day 0
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jan 2018.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Pierre-Géraud Claret, MD principal investigator
Centre Hospitalier Universitaire de Nīmes
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Chest Pain, run by Centre Hospitalier Universitaire de Nīmes at 2 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Jan 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Blood troponin HS concentration (µg/L) (time frame: Day 0, in the ambulance). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Jan 2018.