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.

NCT ID: NCT00714298

Last Updated: 2008-07-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

700 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-05-31

Study Completion Date

2007-03-31

Brief Summary

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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

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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.

Conditions

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Acute Coronary Syndrome

Keywords

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biological markers emergency service hospital heart fatty acid binding protein ischemia modified albumin

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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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.

Group Type OTHER

Measure of Initial heart fatty acid binding protein and ischemia modified albumin

Intervention Type OTHER

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.

Interventions

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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.

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Hospital, Toulouse

OTHER

Sponsor Role lead

Responsible Party

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U H TOULOUSE

Principal Investigators

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Sandrine CHARPENTIER, MD

Role: PRINCIPAL_INVESTIGATOR

U H TOULOUSE

Locations

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Emergency department Rangueil

Toulouse, , France

Site Status

Countries

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France

References

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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.

Reference Type DERIVED
PMID: 22594355 (View on PubMed)

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.

Reference Type DERIVED
PMID: 20659883 (View on PubMed)

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.

Reference Type DERIVED
PMID: 20078436 (View on PubMed)

Other Identifiers

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PHRC

Identifier Type: -

Identifier Source: secondary_id

0503408

Identifier Type: -

Identifier Source: org_study_id