Copeptin and Acute Coronary Syndrome Without ST-segment Elevation
Diagnostic Value of Copeptin Assay for Acute Coronary Syndrome Without ST-segment Elevation
2 other identifiers
interventional
134
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Mar 2011
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2011
CompletedFirst Submitted
Initial submission to the registry
April 11, 2011
CompletedFirst Posted
Study publicly available on registry
April 13, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2012
CompletedMay 29, 2013
May 1, 2013
1 year
April 11, 2011
May 28, 2013
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Copeptin value
at day 1
Secondary Outcomes (1)
Troponin, Myoglobin and Creatin Kinase values. Clinicals and paraclinicals events .
at 90 days
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
Eligibility Criteria
You may qualify if:
- Chest pain suggestive of Acute Coronary Syndrome
- Chest pain with onset within the last 12 h
- Patients older than 18 years
You may not qualify if:
- ST-Elevation Myocardial infarction
- Legal incapacity
- Sepsis
- Hyponatremia \< 135 mmol/L
- Shock
- Lung neoplasms
- life expectancy of less than 6 months
- Refuse to consent
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University Hospital, Clermont-Ferrandlead
- Association des Médecins des Urgences de Clermont-Ferrandcollaborator
- BRAHMS Biomarkerscollaborator
- General Hospital Henri Mondor, Aurillac, Francecollaborator
Study Sites (1)
CHU Clermont-Ferrand
Clermont-Ferrand, 63003, France
Related Publications (1)
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.
PMID: 24662448DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Jonathan DUCHENNE
University Hospital, Clermont-Ferrand
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- DIAGNOSTIC
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 11, 2011
First Posted
April 13, 2011
Study Start
March 1, 2011
Primary Completion
March 1, 2012
Study Completion
March 1, 2012
Last Updated
May 29, 2013
Record last verified: 2013-05