Clinical trial NCT01334645: Copeptin and Acute Coronary Syndrome Without ST-segment Elevation
Official title: Diagnostic Value of Copeptin Assay for Acute Coronary Syndrome Without ST-segment Elevation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chest Pain
Keywords: Copeptin
Troponin
Diagnosis
Chest pain
Acute Coronary Syndrome
Acute Myocardial Infarction
Unstable Angina
Lead sponsor: University Hospital, Clermont-Ferrand
Sponsor class: OTHER
Collaborators: name: Association des Médecins des Urgences de Clermont-Ferrand
name: BRAHMS Biomarkers
name: General Hospital Henri Mondor, Aurillac, France
First posted: 2011-04-13
Enrollment: 134
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: The purpose of this study is to determine whether the combination of copeptine and troponin adds diagnosis information to that provided by troponin alone or the combination of troponin and myoglobin.

Hypothesis : If the values of troponin and copeptin are not elevated, diagnosis of acute myocardial infarction can be ruled out without prolonged monitoring and serial blood sampling.

Detailed description: Patients older than 18 years with pain suggestive of Acute Coronary Syndrome, with onset within the last 12 hours, presenting to the Emergency Department of the University Hospital Gabriel Montpied (Clermont-Ferrand, France) and the General Hospital Henri Mondor (Aurillac, France) are enrolled.

Upon admission to the hospital, all patient underwent an initial clinical assessment, including medical history, temperature, respiratory rate, cardiac frequency, blood pressure, pulse oxymetry, 18-lead ECG, chest X-ray and screening blood test including C reactive protein, natremia, Troponine T, myoglobin, creatin kinase and copeptine.

Patients with hyponatremia \< 135 mmol/L or troponin \> 1 μg/L are released study.

Blood sampling are taken for Troponine T, myoglobin, creatin kinase and copeptine analysis and 18-lead ECG was performed after 2, 4, 6 and 12 h.

Copeptin and myoglobin are measured at the end of the patients inclusion, after to be centrifugrd end frozen at -80°C at each time point.

The treatment of patients is not modified by the study. At 90 days, clinicals and paraclinicals events are collected.

Eligibility criteria: Inclusion Criteria:

* Chest pain suggestive of Acute Coronary Syndrome
* Chest pain with onset within the last 12 h
* Patients older than 18 years

Exclusion Criteria:

* ST-Elevation Myocardial infarction
* Legal incapacity
* Sepsis
* Hyponatremia \< 135 mmol/L
* Shock
* Lung neoplasms
* life expectancy of less than 6 months
* Refuse to consent

Primary outcomes:
measure: Copeptin value
timeFrame: at day 1
Secondary outcomes:
measure: Troponin, Myoglobin and Creatin Kinase values. Clinicals and paraclinicals events .
timeFrame: at 90 days
Other outcomes:
Locations:
city: Clermont-Ferrand
country: France
facility: CHU Clermont-Ferrand
Study officials:
affiliation: University Hospital, Clermont-Ferrand
name: Jonathan DUCHENNE
role: PRINCIPAL_INVESTIGATOR
References:
citation: Duchenne J, Mestres S, Dublanchet N, Combaret N, Marceau G, Caumon L, Dutoit L, Ughetto S, Motreff P, Sapin V, Schmidt J; NSTEMI Study. Diagnostic accuracy of copeptin sensitivity and specificity in patients with suspected non-ST-elevation myocardial infarction with troponin I below the 99th centile at presentation. BMJ Open. 2014 Mar 24;4(3):e004449. doi: 10.1136/bmjopen-2013-004449.