Ignite Creation Date:
2024-05-05 @ 5:20 PM
Last Modification Date:
2024-10-26 @ 9:30 AM
Study NCT ID:
NCT00430820
Status:
COMPLETED
Last Update Posted:
2010-12-03
First Post:
2007-02-01
Brief Title:
Discovery of New Circulating Biomarkers of Coronary Atherosclerosis
Sponsor:
Assistance Publique - Hôpitaux de Paris
Organization:
Assistance Publique - Hôpitaux de Paris
Study Overview
Official Title:
Discovery of New Circulating Biomarkers of Coronary Atherosclerosis Using Differential Proteomics the BIOmarkers of CORonary Events BIOCORE Study
Status:
COMPLETED
Status Verified Date:
2009-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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
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 andor 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 anklebrachial 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 DesorptionIonisation Time-of-Flight SELDI-TOF
Biomarkers with the highest diagnostic value will be subsequently identified using Matrix-Assisted Laser DesorbtionIonisation Time-of-Flight MALDI-TOF and tandem mass spectrometry MSMS
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
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 anklebrachial 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 DesorptionIonisation Time-of-Flight SELDI-TOF
Biomarkers with the highest diagnostic value will be subsequently identified using Matrix-Assisted Laser DesorbtionIonisation Time-of-Flight MALDI-TOF and tandem mass spectrometry MSMS
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None