Acute Coronary SyndromeNCT00714298
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.
A study testing Measure of Initial heart fatty acid binding protein and ischemia modified albumin in people with Acute Coronary Syndrome, run by University Hospital, Toulouse at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Coronary Syndrome
- What is being tested?
- Measure of Initial heart fatty acid binding protein and ischemia modified albumin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 700 participants
- Where
- 1 siteFrance
- Study dates
- May 2006to Mar 2007
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this 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
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.
Read the 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.
- Conditions
- Acute Coronary Syndrome
- Being tested
- Measure of Initial heart fatty acid binding protein and ischemia modified albumin
- Keywords
- biological markers, emergency service hospital, heart fatty acid binding protein, ischemia modified albumin
- Medical subject headings
- Acute Coronary Syndrome, Emergencies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Measure of Initial heart fatty acid binding protein and ischemia modified albuminOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Other | 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. Receives: Other: Measure of Initial heart fatty acid binding protein and ischemia modified albumin |
What is being measured
The primary outcome is the main question the study is designed to answer.
non ST segment elevation ACUTE coronary syndrome diagnosis
Measured: One month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jul 2008 (estimated)
- Study startMay 2006
- Primary completionMar 2007
- Study completionMar 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Acute Coronary SyndromeStudies of the same condition, open and under way.
- More trials run by University Hospital, ToulouseThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 700 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Toulouse
- Sponsor type
- University, hospital or other
- Investigators
- Sandrine CHARPENTIER, MD, Principal investigator, U H TOULOUSE
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00714298
- Sponsor's protocol ID
- 0503408
- Other IDs
- PHRC
- Status last verified
- Jul 2008
- First submitted
- 7 Jul 2008
- Last updated
- 14 Jul 2008
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 22594355Charpentier 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.
PubMed 20659883Charpentier 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.
PubMed 20078436
Study at a glance
From the registry record, last updated by the sponsor on 14 Jul 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00714298
- Acronym / sponsor ID
- 0503408
- Conditions
- Acute Coronary Syndrome
- Keywords
- biological markers, emergency service hospital, heart fatty acid binding protein, ischemia modified albumin
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 700 participants (actual)
- Lead sponsor
- University Hospital, ToulouseUniversity, hospital or other
- Study start
- May 2006
- Primary completion
- Mar 2007 (actual)
- Study completion
- Mar 2007 (actual)
- First posted
- 14 Jul 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | Other | Other: Measure of Initial heart fatty acid binding protein and ischemia modified albuminInitial 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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
Key exclusion criteria (1 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Measure of Initial heart fatty acid binding protein and ischemia modified albuminInitial 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. | Other | 1 |
Primary outcome
non ST segment elevation ACUTE coronary syndrome diagnosis
Time frame: One month
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jul 2008.
- Derived from this study: PubMed 22594355Charpentier 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.
- Derived from this study: PubMed 20659883Charpentier 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.
- Derived from this study: PubMed 20078436Charpentier 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.
Related trials for Acute Coronary Syndrome
Recruiting
CT Stress Myocardial Perfusion, Fractional Flow Reserve and Angiography in Patients With Stable Chest Pain Syndromes
Coronary Artery Disease, Chest Syndrome
Recruiting
WIN Ratio Analysis to Determine a Strategy of Non- Invasive SUpport for Respiratory Failure in the EmeRgency Department
Acute Hypoxic Respiratory Failure, Acute Respiratory Distress Syndrome (ARDS)
RecruitingPhase 4
Early Single Antiplatelet Therapy After IVUS-Guided PCI in Acute Coronary Syndrome
Acute Coronary Syndromes, STEMI
Recruiting
AI-Assisted Interpretation of Cardiac CT in the Emergency Department
Chest Pain, Acute Coronary Syndrome
Enrolling by invitation
Optical Coherence Tomography in Acute Vessel Evaluation
Ischemic Heart Disease, Ischemic Coronary Artery Disease
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sandrine CHARPENTIER, MD principal investigator
U H TOULOUSE
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Measure of Initial heart fatty acid binding protein and ischemia modified albumin in people with Acute Coronary Syndrome, run by University Hospital, Toulouse at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Jul 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
non ST segment elevation ACUTE coronary syndrome diagnosis (time frame: One month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00714298, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jul 2008.