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.
Primary Purpose
Acute Coronary Syndrome
Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Measure of Initial heart fatty acid binding protein and ischemia modified albumin
Sponsored by
About this trial
This is an interventional diagnostic trial for Acute Coronary Syndrome focused on measuring biological markers, emergency service hospital, heart fatty acid binding protein, ischemia modified albumin
Eligibility 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
Sites / Locations
- Emergency department Rangueil
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
1
Arm Description
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.
Outcomes
Primary Outcome Measures
non ST segment elevation ACUTE coronary syndrome diagnosis
Secondary Outcome Measures
Full Information
NCT ID
NCT00714298
First Posted
July 7, 2008
Last Updated
July 11, 2008
Sponsor
University Hospital, Toulouse
1. Study Identification
Unique Protocol Identification Number
NCT00714298
Brief Title
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.
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
Study Type
Interventional
2. Study Status
Record Verification Date
July 2008
Overall Recruitment Status
Completed
Study Start Date
May 2006 (undefined)
Primary Completion Date
March 2007 (Actual)
Study Completion Date
March 2007 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
University Hospital, Toulouse
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Coronary Syndrome
Keywords
biological markers, emergency service hospital, heart fatty acid binding protein, ischemia modified albumin
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
700 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Other
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Measure of Initial heart fatty acid binding protein and ischemia modified albumin
Intervention Description
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.
Primary Outcome Measure Information:
Title
non ST segment elevation ACUTE coronary syndrome diagnosis
Time Frame
One month
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sandrine CHARPENTIER, MD
Organizational Affiliation
U H TOULOUSE
Official's Role
Principal Investigator
Facility Information:
Facility Name
Emergency department Rangueil
City
Toulouse
ZIP/Postal Code
31059
Country
France
12. IPD Sharing Statement
Citations:
PubMed Identifier
22594355
Citation
Charpentier S, Maupas-Schwalm F, Cournot M, Elbaz M, Botella JM, Lauque D. Combination of copeptin and troponin assays to rapidly rule out non-ST elevation myocardial infarction in the emergency department. Acad Emerg Med. 2012 May;19(5):517-24. doi: 10.1111/j.1553-2712.2012.01350.x.
Results Reference
derived
PubMed Identifier
20659883
Citation
Charpentier S, Cournot M, Lauque D, Girardi C, Bounes V, Elbaz M, Ducasse JL. Usefulness of initial glucose level to improve acute coronary syndrome diagnosis in the emergency department. Emerg Med J. 2011 Jul;28(7):564-8. doi: 10.1136/emj.2010.094284. Epub 2010 Jul 20.
Results Reference
derived
PubMed Identifier
20078436
Citation
Charpentier S, Ducasse JL, Cournot M, Maupas-Schwalm F, Elbaz M, Baixas C, Juchet H, Lang T, Lauque D. Clinical assessment of ischemia-modified albumin and heart fatty acid-binding protein in the early diagnosis of non-ST-elevation acute coronary syndrome in the emergency department. Acad Emerg Med. 2010 Jan;17(1):27-35. doi: 10.1111/j.1553-2712.2009.00614.x.
Results Reference
derived
Learn more about this trial
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.
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