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Completed

NCT Number: NCT01334645

Copeptin and Acute Coronary Syndrome Without ST-segment Elevation

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.

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Copeptin

Other

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 outcomes

  1. Copeptin value

    Time frame: at day 1

Secondary outcomes

  1. Troponin, Myoglobin and Creatin Kinase values. Clinicals and paraclinicals events .

    Time frame: at 90 days

Sponsors and collaborators

Lead sponsor

University Hospital, Clermont-Ferrand

Other

Collaborators

  • Association des Médecins des Urgences de Clermont-Ferrand
  • BRAHMS Biomarkers
  • General Hospital Henri Mondor, Aurillac, France

Registry information

Official study title

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

Important dates

Study start
2011
Primary completion
2012
Study completion
2012
First posted
Apr 13, 2011
Registry last updated
May 29, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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