Coronary Artery DiseaseNCT00430820
Discovery of New Circulating Biomarkers of Coronary Atherosclerosis
An observational study of Coronary Artery Disease and Acute Coronary Syndromes, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial summary
The study hypothesis is that differential proteomic techniques can be used to discover new circulating biomarkers of coronary atherosclerosis in the blood of patients suffering from coronary artery disease (either stable or unstable) who will be compared to a group of patients without coronary artery disease Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Coronary Artery Disease, Acute Coronary Syndromes, Myocardial Infarction
- What is being tested?
- per intervention
- Type of treatment
- Surgery or procedure
- How many people
- 124 participants
- Where
- 1 siteFrance
- Study dates
- Mar 2007to Nov 2009
- Phase
- Observational
- 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Identification de nouveaux marqueurs circulants de l'athérosclérose coronarienne et de ses complications par une nouvelle technique de protéomique différentielle. Identification of new parqueurs circulated in coronary artheriosclerosis and complications of the new differentiel technicology
Who may be able to join
- Group 1 (Non-ST-elevation acute myocardial infarction) :
- Chest pain less than 48 hours before admission,
- And modifications of ST-T (no persistent ST elevation) on 12-lead EKG,
- And elevation of troponin-I >1xN,
- And presence of ≥1 de novo stenosis(es) >50% located on ≥1 native coronary artery(ies) and successfully treated using percutaneous coronary intervention and stenting.
- Group 2 (Stable coronary artery disease) :
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- Documented myocardial ischemia (stable angina or positive stress test)
- And presence of ≥1 de novo stenosis(es) >50% located on ≥1 native coronary artery(ies) and successfully treated using percutaneous coronary intervention and stenting.
- Group 3 (Normal coronary arteries) :
- No history of coronary artery disease, neurovascular disease or peripheral artery disease,
- And normal coronary angiography performed because of suspected coronary artery disease
- And absence of significant functional or anatomic abnormalities suggestive of atherosclerosis on non-invasive arterial studies (measurements of intima-media thickness, pulse wave velocity, ankle-brachial index, …).
Who cannot join
- Group 1 :
- Preexisting EKG abnormalities (including left bundle branch block) precluding accurate assessment of ST-T changes
- Group 2 :
- History of acute coronary syndrome
- Groups 1 and 2:
- Culprit coronary artery stenosis is a restenosis or a stent thrombosis or is located in a bypass graft.
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- All groups :
- Heart failure (NYHA class ≥II)
- Left ventricular ejection fraction <50%
- Severe valvular heart disease requiring surgical or percutaneous therapy
- History of autoimmune, inflammatory or neoplasia diseases ; or infectious disease in the month before admission
- Life expectancy < 1 year
- Age <18 years or >80 years
- Current pregnancy or breast-feeding
- Homeless or travelers who may not be followed-up
- Refusal to sign the informed consent form
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Discovery of New Circulating Biomarkers of Coronary Atherosclerosis Using Differential Proteomics: the BIOmarkers of CORonary Events (BIOCORE) Study
The study hypothesis is that differential proteomic techniques can be used to discover new circulating biomarkers of coronary atherosclerosis in the blood of patients suffering from coronary artery disease (either stable or unstable) who will be compared to a group of patients without coronary artery disease
Read the detailed description
Hypothesis: Our hypothesis is that coronary atherosclerosis induces both quantitative and qualitative modifications of circulating proteins, which can be captured by a differential proteomic approach applied to serum or plasma samples. Identification of such modifications in the circulating blood of patients with coronary artery disease (versus patients without coronary artery disease) and/or of patients with acute coronary syndromes (versus stable coronary artery disease) may lead to discovery of new biomarkers of coronary atherosclerosis and of atherosclerotic plaque vulnerability.
Objectives:
Primary objective: Identification of new circulating biomarkers of stable and unstable coronary artery disease using a new approach of differential proteomics.
Secondary objectives:
- Evaluation of the diagnostic value of these new biomarkers for the diagnosis of stable and unstable coronary artery disease.
- Comparison of the diagnostic value of these new biomarkers to the diagnostic value of 1) other validated biomarkers of atherosclerosis (eg, CRP, IL-6, CD40L, markers of leukocyte activation, …); and 2) of non-invasive measures of arterial function (eg, carotid artery intima-media thickness, pulse wave velocity, ankle/brachial index, …)
- Description of the relationship between these new biomarkers and major adverse coronary events (death, myocardial infarction, revascularization) during a 12-month follow-up.
Methods:
Uniq center, prospective study. Three groups of patients will be studied. Group 1: Non-ST-elevation acute myocardial infarction; Group 2: Stable coronary artery disease; Group 3: normal coronary arteries and absence of other detectable atherosclerotic lesions.
A new proteomic approach will be applied to serum and plasma samples obtained 1 month after the index hospitalisation. This approach includes 3 steps: 1) equalisation of circulating proteins (expose low-concentration proteins belonging to the "deep-proteome"); 2) Retention chromatography; and 3) protein separation using 2D-electrophoresis and Surface-Enhanced Laser Desorption/Ionisation Time-of-Flight (SELDI-TOF).
Biomarkers with the highest diagnostic value will be subsequently identified using Matrix-Assisted Laser Desorbtion/Ionisation Time-of-Flight (MALDI-TOF) and tandem mass spectrometry (MS/MS).
Perspectives:
Validation of the diagnostic and prognostic values of the new biomarkers discovered and identified using the proteomic approach described above will require development of more straightforward measurement techniques (eg, ELISA), which will be used prospectively or retrospectively in other cohorts of patients with coronary artery disease. Basic studies will be performed in parallel, so as to better understand the role of these new biomarkers in the pathophysiology of atherosclerosis.
- Being tested
- per intervention
- Keywords
- Biomarkers, Proteomics, Mass spectrometry, Atherosclerosis, Acute coronary syndromes, Myocardial infarction, Coronary artery disease
- Medical subject headings
- Coronary Artery Disease, Acute Coronary Syndrome, Myocardial Infarction, Atherosclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
per interventionProcedure or surgery
per intervention
| Study group | Role | What they receive |
|---|---|---|
| 1 | 30 patients Receives: Procedure: per intervention | |
| 2 | 30 patients Receives: Procedure: per intervention | |
| 3 | 30 patients Receives: Procedure: per intervention |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Feb 2007 (estimated)
- Study startMar 2007
- Primary completionJul 2009
- Study completionNov 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Coronary Artery DiseaseStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe 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
- Observational
- Time perspective
- Prospective
- Enrolment
- 124 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Collaborators
- Fédération Française de Cardiologie, Société Française de Cardiologie
- Investigators
- Laurent FELDMAN, MD,PhD, Principal investigator, Assistance Publique - Hôpitaux de Paris
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00430820
- Sponsor's protocol ID
- P060201
- Status last verified
- Apr 2009
- First submitted
- 1 Feb 2007
- Last updated
- 3 Dec 2010
- Results posted
- No
- Data monitoring committee
- No
Publications
Duran MC, Mas S, Martin-Ventura JL, Meilhac O, Michel JB, Gallego-Delgado J, Lazaro A, Tunon J, Egido J, Vivanco F. Proteomic analysis of human vessels: application to atherosclerotic plaques. Proteomics. 2003 Jun;3(6):973-8. doi: 10.1002/pmic.200300389.
PubMed 12833522Martin-Ventura JL, Duran MC, Blanco-Colio LM, Meilhac O, Leclercq A, Michel JB, Jensen ON, Hernandez-Merida S, Tunon J, Vivanco F, Egido J. Identification by a differential proteomic approach of heat shock protein 27 as a potential marker of atherosclerosis. Circulation. 2004 Oct 12;110(15):2216-9. doi: 10.1161/01.CIR.0000136814.87170.B1. Epub 2004 Jul 12.
PubMed 15249501Vivanco F, Martin-Ventura JL, Duran MC, Barderas MG, Blanco-Colio L, Darde VM, Mas S, Meilhac O, Michel JB, Tunon J, Egido J. Quest for novel cardiovascular biomarkers by proteomic analysis. J Proteome Res. 2005 Jul-Aug;4(4):1181-91. doi: 10.1021/pr0500197.
PubMed 16083268Blanco-Colio LM, Martin-Ventura JL, Vivanco F, Michel JB, Meilhac O, Egido J. Biology of atherosclerotic plaques: what we are learning from proteomic analysis. Cardiovasc Res. 2006 Oct 1;72(1):18-29. doi: 10.1016/j.cardiores.2006.05.017. Epub 2006 May 24.
PubMed 16814757Ramos-Mozo P, Madrigal-Matute J, Vega de Ceniga M, Blanco-Colio LM, Meilhac O, Feldman L, Michel JB, Clancy P, Golledge J, Norman PE, Egido J, Martin-Ventura JL. Increased plasma levels of NGAL, a marker of neutrophil activation, in patients with abdominal aortic aneurysm. Atherosclerosis. 2012 Feb;220(2):552-6. doi: 10.1016/j.atherosclerosis.2011.11.023. Epub 2011 Nov 25.
PubMed 22169111
Study at a glance
From the registry record, last updated by the sponsor on 3 Dec 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Discovery of New Circulating Biomarkers of Coronary Atherosclerosis Using Differential Proteomics: the BIOmarkers of CORonary Events (BIOCORE) Study
- ClinicalTrials.gov ID
- NCT00430820
- Acronym / sponsor ID
- P060201
- Keywords
- Biomarkers, Proteomics, Mass spectrometry, Atherosclerosis, Acute coronary syndromes, Myocardial infarction, Coronary artery disease
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 124 participants (actual)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Collaborators
- Fédération Française de Cardiologie, Société Française de Cardiologie
- Study start
- Mar 2007
- Primary completion
- Jul 2009 (actual)
- Study completion
- Nov 2009 (actual)
- First posted
- 2 Feb 2007 (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.
The study hypothesis is that differential proteomic techniques can be used to discover new circulating biomarkers of coronary atherosclerosis in the blood of patients suffering from coronary artery disease (either stable or unstable) who will be compared to a group of patients without coronary artery disease
Detailed description
Hypothesis: Our hypothesis is that coronary atherosclerosis induces both quantitative and qualitative modifications of circulating proteins, which can be captured by a differential proteomic approach applied to serum or plasma samples. Identification of such modifications in the circulating blood of patients with coronary artery disease (versus patients without coronary artery disease) and/or of patients with acute coronary syndromes (versus stable coronary artery disease) may lead to discovery of new biomarkers of coronary atherosclerosis and of atherosclerotic plaque vulnerability.
Objectives:
Primary objective: Identification of new circulating biomarkers of stable and unstable coronary artery disease using a new approach of differential proteomics.
Secondary objectives:
- Evaluation of the diagnostic value of these new biomarkers for the diagnosis of stable and unstable coronary artery disease.
- Comparison of the diagnostic value of these new biomarkers to the diagnostic value of 1) other validated biomarkers of atherosclerosis (eg, CRP, IL-6, CD40L, markers of leukocyte activation, …); and 2) of non-invasive measures of arterial function (eg, carotid artery intima-media thickness, pulse wave velocity, ankle/brachial index, …)
- Description of the relationship between these new biomarkers and major adverse coronary events (death, myocardial infarction, revascularization) during a 12-month follow-up.
Methods:
Uniq center, prospective study. Three groups of patients will be studied. Group 1: Non-ST-elevation acute myocardial infarction; Group 2: Stable coronary artery disease; Group 3: normal coronary arteries and absence of other detectable atherosclerotic lesions.
A new proteomic approach will be applied to serum and plasma samples obtained 1 month after the index hospitalisation. This approach includes 3 steps: 1) equalisation of circulating proteins (expose low-concentration proteins belonging to the "deep-proteome"); 2) Retention chromatography; and 3) protein separation using 2D-electrophoresis and Surface-Enhanced Laser Desorption/Ionisation Time-of-Flight (SELDI-TOF).
Biomarkers with the highest diagnostic value will be subsequently identified using Matrix-Assisted Laser Desorbtion/Ionisation Time-of-Flight (MALDI-TOF) and tandem mass spectrometry (MS/MS).
Perspectives:
Validation of the diagnostic and prognostic values of the new biomarkers discovered and identified using the proteomic approach described above will require development of more straightforward measurement techniques (eg, ELISA), which will be used prospectively or retrospectively in other cohorts of patients with coronary artery disease. Basic studies will be performed in parallel, so as to better understand the role of these new biomarkers in the pathophysiology of atherosclerosis.
Study design
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 1 | – | Procedure: per intervention30 patients |
| 2 | – | Procedure: per intervention30 patients |
| 3 | – | Procedure: per intervention30 patients |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Identification de nouveaux marqueurs circulants de l'athérosclérose coronarienne et de ses complications par une nouvelle technique de protéomique différentielle. Identification of new parqueurs circulated in coronary artheriosclerosis and complications of the new differentiel technicology
Key inclusion criteria (12 listed)
- Group 1 (Non-ST-elevation acute myocardial infarction) :
- Group 2 (Stable coronary artery disease) :
- Group 3 (Normal coronary arteries) :
Key exclusion criteria (16 listed)
- Group 1 :
- Group 2 :
- Groups 1 and 2:
- All groups :
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 |
|---|---|---|
| per interventionper intervention | Procedure or surgery | 1, 2, 3 |
Primary outcome
Not reported in the source record.
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 3 Dec 2010.
- Results publication: PubMed 12833522Duran MC, Mas S, Martin-Ventura JL, Meilhac O, Michel JB, Gallego-Delgado J, Lazaro A, Tunon J, Egido J, Vivanco F. Proteomic analysis of human vessels: application to atherosclerotic plaques. Proteomics. 2003 Jun;3(6):973-8. doi: 10.1002/pmic.200300389.
- Results publication: PubMed 15249501Martin-Ventura JL, Duran MC, Blanco-Colio LM, Meilhac O, Leclercq A, Michel JB, Jensen ON, Hernandez-Merida S, Tunon J, Vivanco F, Egido J. Identification by a differential proteomic approach of heat shock protein 27 as a potential marker of atherosclerosis. Circulation. 2004 Oct 12;110(15):2216-9. doi: 10.1161/01.CIR.0000136814.87170.B1. Epub 2004 Jul 12.
- Results publication: PubMed 16083268Vivanco F, Martin-Ventura JL, Duran MC, Barderas MG, Blanco-Colio L, Darde VM, Mas S, Meilhac O, Michel JB, Tunon J, Egido J. Quest for novel cardiovascular biomarkers by proteomic analysis. J Proteome Res. 2005 Jul-Aug;4(4):1181-91. doi: 10.1021/pr0500197.
- Results publication: PubMed 16814757Blanco-Colio LM, Martin-Ventura JL, Vivanco F, Michel JB, Meilhac O, Egido J. Biology of atherosclerotic plaques: what we are learning from proteomic analysis. Cardiovasc Res. 2006 Oct 1;72(1):18-29. doi: 10.1016/j.cardiores.2006.05.017. Epub 2006 May 24.
- Derived from this study: PubMed 22169111Ramos-Mozo P, Madrigal-Matute J, Vega de Ceniga M, Blanco-Colio LM, Meilhac O, Feldman L, Michel JB, Clancy P, Golledge J, Norman PE, Egido J, Martin-Ventura JL. Increased plasma levels of NGAL, a marker of neutrophil activation, in patients with abdominal aortic aneurysm. Atherosclerosis. 2012 Feb;220(2):552-6. doi: 10.1016/j.atherosclerosis.2011.11.023. Epub 2011 Nov 25.
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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.
Laurent FELDMAN, MD,PhD principal investigator
Assistance Publique - Hôpitaux de Paris
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Coronary Artery Disease and Acute Coronary Syndromes, run by Assistance Publique - Hôpitaux de Paris 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 12 inclusion and 16 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 3 Dec 2010. 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.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00430820, which also lists 5 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 3 Dec 2010.