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Diagnostic Value of Heart-Fatty Acid Binding Protein and Ischemia Modified Albumin as Biochemical Markers on Non ST Segment Elevation Acute Coronary Syndrome at the Emergency Room.
This study has been completed.
Sponsored by: University Hospital, Toulouse
Information provided by: University Hospital, Toulouse
ClinicalTrials.gov Identifier: NCT00714298
  Purpose

Early diagnostic of non ST elevation coronary syndrome in patients admitted to the emergency room is difficult. Two news biochemical markers have been assessed and studies have suggested that heart fatty binding protein and ischemia modified albumin are early markers of myocardial necrosis and myocardial ischemia. The aim of the study is to analyse the predictive value of association of heart fatty binding protein and ischemia modified albumin for non ST segment elevation acute coronary syndrome diagnosis in the first hour of management in the emergency room.


Condition Intervention
Acute Coronary Syndrome
Other: Measure of Initial heart fatty acid binding protein and ischemia modified albumin

U.S. FDA Resources
Study Type: Interventional
Study Design: Diagnostic, Open Label, Uncontrolled, Single Group Assignment, Efficacy Study
Official Title: Analyse en médecine d'Urgence d'Une stratégie d'Utilisation combinée de Deux Marqueurs Biologiques Dans le Diagnostic de Syndrome Coronaire Aigu Non ST+: étude Des Performances de la Heart-Fatty Acid Binding Protein et de l' Ischemia Modified Albumin dès la première Heure de Prise en Charge

Further study details as provided by University Hospital, Toulouse:

Primary Outcome Measures:
  • non ST segment elevation ACUTE coronary syndrome diagnosis [ Time Frame: One month ] [ Designated as safety issue: No ]

Enrollment: 700
Study Start Date: May 2006
Study Completion Date: March 2007
Primary Completion Date: March 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
1
Initial heart fatty acid binding protein and ischemia modified albumin will be measured after patient's arrival in the emergency room. Treating physicians, biologist physician will be blinded to the results of the markers.
Other: Measure of Initial heart fatty acid binding protein and ischemia modified albumin
Initial heart fatty acid binding protein and ischemia modified albumin will be measured after patient's arrival in the emergency room. The aim of the study is to analyse the predictive value of association of heart fatty binding protein and ischemia modified albumin for non ST segment elevation acute coronary syndrome diagnosis in the first hour of management in the emergency room.Treating physicians, biologist physician will be blinded to the results of the markers.

Detailed Description:

Early diagnostic of non ST elevation coronary syndrome (ACS) in patients admitted to the emergency room is difficult. Two news biochemical markers have been assessed and studies have suggested that heart fatty binding protein and ischemia modified albumin are early markers of myocardial necrosis and myocardial ischemia.

Study objective: The aim of the study is to analyse the predictive value of association of heart fatty binding protein and ischemia modified albumin for non ST segment elevation ACS diagnosis in the first hour of management in emergency room.

Methods: In a prospective double blind study, initial heart fatty binding protein and ischemia modified albumin levels will be measured in consecutive patients admitted in the emergency room with chest pain and suspected non-ST elevation ACS. Data including history, physical examination, serial 12-lead ECG and troponin-I measurement at 0 and 6 hours after admission will be collected by the treating physician blinded to the result of the markers. Based on hospital diagnosis algorithm (troponin repeated measurements, treadmill test or other ischemia detection, coronarography if necessary) and follow-up at one month, patients will be classified as having or no non-ST elevation ACS by two independent physicians blinded to the results of markers. Sensitivity, specificity, positive and negative predictive values will be determined for each marker and in combined analyses.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • All consecutive patients admitted in the emergency room with a primary complaint of chest pain evolving within 12 hours and suspected as acute coronary syndrome

Exclusion Criteria:

  • patient younger than 18 years old, having an ST elevation on a 12-lead ECG, having an evident traumatic cause of chest pain or having severe communication problems
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00714298

Locations
France
Emergency department Rangueil
TOULOUSE, France, 31059
Sponsors and Collaborators
University Hospital, Toulouse
Investigators
Principal Investigator: Sandrine CHARPENTIER, MD U H TOULOUSE
  More Information

Responsible Party: U H TOULOUSE ( Nathalie ROQUES )
Study ID Numbers: 0503408, PHRC
Study First Received: July 7, 2008
Last Updated: July 11, 2008
ClinicalTrials.gov Identifier: NCT00714298  
Health Authority: France: Ministry of Health

Keywords provided by University Hospital, Toulouse:
biological markers
emergency service hospital
heart fatty acid binding protein
ischemia modified albumin

Study placed in the following topic categories:
Heart Diseases
Myocardial Ischemia
Acute Coronary Syndrome
Vascular Diseases
Emergencies
Ischemia

Additional relevant MeSH terms:
Disease
Pathologic Processes
Syndrome
Cardiovascular Diseases

ClinicalTrials.gov processed this record on January 16, 2009