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.

Not Applicable

Completed

• Conditions: Acute Coronary Syndrome
• Interventions: Other: Measure of Initial heart fatty acid binding protein and ischemia modified albumin

• Registration Number: NCT00714298
• Lead Sponsor: University Hospital, Toulouse

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.

Study Timeline

• Study Start: 2006-05
• Primary Completion: 2007-03
• Study Completion: 2007-03
• Status Verified: 2008-07
• Study First Submitted: 2008-07-07
• Study First Submitted QC: 2008-07-11
• Last Update Submitted: 2008-07-11
• Study First Posted: 2008-07-14
• Last Update Posted: 2008-07-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 700

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
1	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. Treating physicians, biologist physician will be blinded to the results of the markers.

Primary Outcome Measures

Name	Time	Method
non ST segment elevation ACUTE coronary syndrome diagnosis	One month

Trial Locations

Locations (1)

Emergency department Rangueil; 🇫🇷 Toulouse, France