Copeptin and Acute Coronary Syndrome Without ST-segment Elevation
Primary Purpose
Chest Pain
Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Copeptin
Sponsored by
About this trial
This is an interventional diagnostic trial for Chest Pain focused on measuring Copeptin, Troponin, Diagnosis, Chest pain, Acute Coronary Syndrome, Acute Myocardial Infarction, Unstable Angina
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
Sites / Locations
- CHU Clermont-Ferrand
Outcomes
Primary Outcome Measures
Copeptin value
Secondary Outcome Measures
Troponin, Myoglobin and Creatin Kinase values. Clinicals and paraclinicals events .
Full Information
NCT ID
NCT01334645
First Posted
April 11, 2011
Last Updated
May 28, 2013
Sponsor
University Hospital, Clermont-Ferrand
Collaborators
Association des Médecins des Urgences de Clermont-Ferrand, BRAHMS Biomarkers, General Hospital Henri Mondor, Aurillac, France
1. Study Identification
Unique Protocol Identification Number
NCT01334645
Brief Title
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
2. Study Status
Record Verification Date
May 2013
Overall Recruitment Status
Completed
Study Start Date
March 2011 (undefined)
Primary Completion Date
March 2012 (Actual)
Study Completion Date
March 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Clermont-Ferrand
Collaborators
Association des Médecins des Urgences de Clermont-Ferrand, BRAHMS Biomarkers, General Hospital Henri Mondor, Aurillac, France
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chest Pain
Keywords
Copeptin, Troponin, Diagnosis, Chest pain, Acute Coronary Syndrome, Acute Myocardial Infarction, Unstable Angina
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
Participant
Allocation
Non-Randomized
Enrollment
134 (Actual)
8. Arms, Groups, and Interventions
Intervention Type
Other
Intervention Name(s)
Copeptin
Intervention Description
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
Primary Outcome Measure Information:
Title
Copeptin value
Time Frame
at day 1
Secondary Outcome Measure Information:
Title
Troponin, Myoglobin and Creatin Kinase values. Clinicals and paraclinicals events .
Time Frame
at 90 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jonathan DUCHENNE
Organizational Affiliation
University Hospital, Clermont-Ferrand
Official's Role
Principal Investigator
Facility Information:
Facility Name
CHU Clermont-Ferrand
City
Clermont-Ferrand
ZIP/Postal Code
63003
Country
France
12. IPD Sharing Statement
Citations:
PubMed Identifier
24662448
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. Erratum In: BMJ Open. 2014;4(4):e004449corr1.
Results Reference
derived
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Copeptin and Acute Coronary Syndrome Without ST-segment Elevation
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