Copeptin and Acute Coronary Syndrome Without ST-segment Elevation

This study has been completed.
Sponsor:
Collaborators:
ASMUC : Association des Médecins des Urgences de Clermont-Ferrand
BRAHMS Biomarkers
General Hospital Henri Mondor, Aurillac, France
Information provided by (Responsible Party):
University Hospital, Clermont-Ferrand
ClinicalTrials.gov Identifier:
NCT01334645
First received: April 11, 2011
Last updated: May 28, 2013
Last verified: May 2013
  Purpose

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.


Condition Intervention
Chest Pain
Other: Copeptin

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Single Blind (Subject)
Primary Purpose: Diagnostic
Official Title: Diagnostic Value of Copeptin Assay for Acute Coronary Syndrome Without ST-segment Elevation

Resource links provided by NLM:


Further study details as provided by University Hospital, Clermont-Ferrand:

Primary Outcome Measures:
  • Copeptin value [ Time Frame: at day 1 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Troponin, Myoglobin and Creatin Kinase values. Clinicals and paraclinicals events . [ Time Frame: at 90 days ] [ Designated as safety issue: Yes ]

Enrollment: 134
Study Start Date: March 2011
Study Completion Date: March 2012
Primary Completion Date: March 2012 (Final data collection date for primary outcome measure)
Intervention Details:
    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

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01334645

Locations
France
CHU Clermont-Ferrand
Clermont-Ferrand, France, 63003
Sponsors and Collaborators
University Hospital, Clermont-Ferrand
ASMUC : Association des Médecins des Urgences de Clermont-Ferrand
BRAHMS Biomarkers
General Hospital Henri Mondor, Aurillac, France
Investigators
Principal Investigator: Jonathan DUCHENNE University Hospital, Clermont-Ferrand
  More Information

No publications provided

Responsible Party: University Hospital, Clermont-Ferrand
ClinicalTrials.gov Identifier: NCT01334645     History of Changes
Other Study ID Numbers: CHU-0092, 2010-A01186-33
Study First Received: April 11, 2011
Last Updated: May 28, 2013
Health Authority: France: Ministry of Health

Keywords provided by University Hospital, Clermont-Ferrand:
Copeptin
Troponin
Diagnosis
Chest pain
Acute Coronary Syndrome
Acute Myocardial Infarction
Unstable Angina

Additional relevant MeSH terms:
Chest Pain
Acute Coronary Syndrome
Pain
Signs and Symptoms
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Angina Pectoris
Vascular Diseases

ClinicalTrials.gov processed this record on April 16, 2014