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Copeptin and Acute Coronary Syndrome Without ST-segment Elevation

Diagnostic Value of Copeptin Assay for Acute Coronary Syndrome Without ST-segment Elevation

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01334645
Enrollment
134
Registered
2011-04-13
Start date
2011-03-01
Completion date
2012-03-01
Last updated
2026-08-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chest Pain

Keywords

Copeptin, Troponin, Diagnosis, Chest pain, Acute Coronary Syndrome, Acute Myocardial Infarction, Unstable Angina

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.

Interventions

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

Sponsors

University Hospital, Clermont-Ferrand
Lead SponsorOTHER
Association des Médecins des Urgences de Clermont-Ferrand
CollaboratorOTHER
BRAHMS Biomarkers
CollaboratorUNKNOWN
General Hospital Henri Mondor, Aurillac, France
CollaboratorUNKNOWN

Study design

Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
SINGLE (Subject)

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
Copeptin valueat day 1

Secondary

MeasureTime frame
Troponin, Myoglobin and Creatin Kinase values. Clinicals and paraclinicals events .at 90 days

Countries

France

Contacts

PRINCIPAL_INVESTIGATORJonathan DUCHENNE

University Hospital, Clermont-Ferrand

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Aug 7, 2026