Copeptin and Acute Coronary Syndrome Without ST-segment Elevation

Chest Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01334645
• Other study ID #: CHU-0092
• Secondary ID: 2010-A01186-33
• Status: Completed
• Phase: N/A
• First received: April 11, 2011
• Last updated: May 28, 2013
• Start date: March 2011
• Est. completion date: March 2012

Study information

• Verified date: May 2013
• Source: University Hospital, Clermont-Ferrand
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 134
• Est. completion date: March 2012
• Est. primary completion date: March 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Single Blind (Subject), Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Acute Coronary Syndrome
• Chest Pain

Intervention

Other:
• Copeptin
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

Locations

Country	Name	City	State
France	CHU Clermont-Ferrand	Clermont-Ferrand

Sponsors (4)

Lead Sponsor	Collaborator
University Hospital, Clermont-Ferrand	Association des Médecins des Urgences de Clermont-Ferrand, BRAHMS Biomarkers, General Hospital Henri Mondor, Aurillac, France

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Copeptin value		at day 1	Yes
Secondary	Troponin, Myoglobin and Creatin Kinase values. Clinicals and paraclinicals events .		at 90 days	Yes