Ignite Creation Date:
2024-05-05 @ 5:28 PM
Last Modification Date:
2024-10-26 @ 9:32 AM
Study NCT ID:
NCT00466050
Status:
COMPLETED
Last Update Posted:
2009-08-25
First Post:
2007-04-25
Brief Title:
Correlation Between Serum Markers of Unstable Plaque and Virtual Histology of Unstable Plaque Visualized by IVUS
Sponsor:
Ziv Hospital
Organization:
Ziv Hospital
Study Overview
Official Title:
Correlation Between Serum Markers of Unstable Plaque and Virtual Histology of Unstable Plaque Visualized by IVUS
Status:
COMPLETED
Status Verified Date:
2007-04
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:
IVUS
Brief Summary:
Thirty patients scheduled to coronary angiography and IVUS in according to their treating physician decision will be enrolled in the study The coronary angiography and IVUS will be done on according to regular clinical standards
As the study protocol 40 cc of blood will be drawn from the patients after written informed consent
The laboratory tests will be processed for the above mentioned serum markers of unstable plaque
A multivariate correlation test will be done between the different serum markers and the plaque morphology by angiography and composition virtual histology by IVUS
As the study protocol 40 cc of blood will be drawn from the patients after written informed consent
The laboratory tests will be processed for the above mentioned serum markers of unstable plaque
A multivariate correlation test will be done between the different serum markers and the plaque morphology by angiography and composition virtual histology by IVUS
Detailed Description:
Serum markers of unstable plaque Myeloperoxidase is a lysosomal enzyme requiring heme as a cofactor released from neutrophilic granules monocytes and some subtypes of tissue macrophages
Myeloperoxidase is also linked to oxidation of lipids in low-density lipoproteins LDL dysfunctional high density lipoproteins HDL and consumption of nitric oxide thereby rendering the normally anti-thrombotic endothelial surface thrombogenic via the expression of various pro-thrombotic and anti-fibrinolytic factor 19
Myeloperoxidase plays a role in the degradation of the fibrous cap making it both a marker of inflammation and one of plaque instability
Interest in MPO intensified after a report by Brennan and colleagues 20 indicated that a single initial measurement of plasma myeloperoxidase independently predicts the early risk of myocardial infraction as well as the risk of major adverse cardiac events in the ensuring 30-day and 6-month periods
Two markers of recent interest relating to plaque vulnerability pregnancy-associated protein APAPP-A and placenta growth factor P1GF
Pregnancy -associated protein A is a metalloproteinase initially identified in the sera of pregnant women 21
A large study has illustrated that decreases in IGF-1 appear to be cardio protective yet some research shows that increases in PAPP-A which should also increase the bioavailability of IGF-1 may be a relevant marker for the presence and extent of coronary atherosclerosis 22 It is believed that PAPP-A is released during plaque destabilization and appears to be a valuable indicator of unstable angina and acute MI in patients lacking other indicators of necrosis 23
Placenta growth factor is a member of the vascular endothelial growth factor family which stimulates vascular smooth muscle growth recruits macrophages into atherosclerotic lesion up-regulates production of tumor necrosis factor- and monocyte chemotactic protein 1 by macrophages and stimulates pathological angiogenesis 24 It appears to be an initiator of the inflammatory process
In one study elevated P1GF levels not only identified patients with acute chest pain who developed ACS but also those patients with an increased risk of recurrent instability after hospital discharge 25
Plasma elevation of CRP have been reported fraction and are acute ischemia and myocardial in fraction and are predictive of the risk of recurrent ischemia among hospitalization patients with unstable angina 26
Matrix metalloproteinases MMPs are a diverse family of powerful zinc-containing enzymes expressed by macrophage- derived foam cells SMCs and other vascular cells within atherosclerotic lesions 27 It has been previously demonstrated that MMPs are responsible for remodeling of the ECM during all stages of atheromatous development and may directly contribute to fibrous cap weakening and plaque rupture within disease arteries 28
CD40 ligand CD40L is an immunoregulatory transmembrane protein that belongs to the tumor necrosis factor TNF super family It is expressed on the surface of many cells types including leukocytes ECs SMSs macrophages and activated platelets 29 Ligand receptor binding on these cells triggers the expression and secretion of a variety of pro-inflammatory and procoagulant mediators including CAMs cytokines chemokines growth factors MMPs and TF 29 Recent data suggest that CD40L plays a central role in the inflammatory process that contributes to plaque destabilization in CAD 30 and elevation in soluble biologically active CD40L Scd40l have been demonstrated in the serum of ACS patients 31
Paraoxonase and atherogenic HDL The enzyme PON1 is known to be tightly bound with HDL in serum and several studies suggest that it is this association that contributes to the protection conferred by HDL against LDL oxidation 33-36
The aim of the study is to find a correlation between serum markers of unstable plaque and virtual histology of unstable plaque visualized by IVUS
Patients and methods
Thirty patients scheduled to coronary angiography and IVUS in according to their treating physician decision will be enrolled in the study The coronary angiography and IVUS will be done on according to regular clinical standards
As the study protocol 40 cc of blood will be drawn from the patients after written informed consent
The laboratory tests will be processed for the above mentioned serum markers of unstable plaque
A multivariate correlation test will be done between the different serum markers and the plaque morphology by angiography and composition virtual histology by IVUS
Myeloperoxidase is also linked to oxidation of lipids in low-density lipoproteins LDL dysfunctional high density lipoproteins HDL and consumption of nitric oxide thereby rendering the normally anti-thrombotic endothelial surface thrombogenic via the expression of various pro-thrombotic and anti-fibrinolytic factor 19
Myeloperoxidase plays a role in the degradation of the fibrous cap making it both a marker of inflammation and one of plaque instability
Interest in MPO intensified after a report by Brennan and colleagues 20 indicated that a single initial measurement of plasma myeloperoxidase independently predicts the early risk of myocardial infraction as well as the risk of major adverse cardiac events in the ensuring 30-day and 6-month periods
Two markers of recent interest relating to plaque vulnerability pregnancy-associated protein APAPP-A and placenta growth factor P1GF
Pregnancy -associated protein A is a metalloproteinase initially identified in the sera of pregnant women 21
A large study has illustrated that decreases in IGF-1 appear to be cardio protective yet some research shows that increases in PAPP-A which should also increase the bioavailability of IGF-1 may be a relevant marker for the presence and extent of coronary atherosclerosis 22 It is believed that PAPP-A is released during plaque destabilization and appears to be a valuable indicator of unstable angina and acute MI in patients lacking other indicators of necrosis 23
Placenta growth factor is a member of the vascular endothelial growth factor family which stimulates vascular smooth muscle growth recruits macrophages into atherosclerotic lesion up-regulates production of tumor necrosis factor- and monocyte chemotactic protein 1 by macrophages and stimulates pathological angiogenesis 24 It appears to be an initiator of the inflammatory process
In one study elevated P1GF levels not only identified patients with acute chest pain who developed ACS but also those patients with an increased risk of recurrent instability after hospital discharge 25
Plasma elevation of CRP have been reported fraction and are acute ischemia and myocardial in fraction and are predictive of the risk of recurrent ischemia among hospitalization patients with unstable angina 26
Matrix metalloproteinases MMPs are a diverse family of powerful zinc-containing enzymes expressed by macrophage- derived foam cells SMCs and other vascular cells within atherosclerotic lesions 27 It has been previously demonstrated that MMPs are responsible for remodeling of the ECM during all stages of atheromatous development and may directly contribute to fibrous cap weakening and plaque rupture within disease arteries 28
CD40 ligand CD40L is an immunoregulatory transmembrane protein that belongs to the tumor necrosis factor TNF super family It is expressed on the surface of many cells types including leukocytes ECs SMSs macrophages and activated platelets 29 Ligand receptor binding on these cells triggers the expression and secretion of a variety of pro-inflammatory and procoagulant mediators including CAMs cytokines chemokines growth factors MMPs and TF 29 Recent data suggest that CD40L plays a central role in the inflammatory process that contributes to plaque destabilization in CAD 30 and elevation in soluble biologically active CD40L Scd40l have been demonstrated in the serum of ACS patients 31
Paraoxonase and atherogenic HDL The enzyme PON1 is known to be tightly bound with HDL in serum and several studies suggest that it is this association that contributes to the protection conferred by HDL against LDL oxidation 33-36
The aim of the study is to find a correlation between serum markers of unstable plaque and virtual histology of unstable plaque visualized by IVUS
Patients and methods
Thirty patients scheduled to coronary angiography and IVUS in according to their treating physician decision will be enrolled in the study The coronary angiography and IVUS will be done on according to regular clinical standards
As the study protocol 40 cc of blood will be drawn from the patients after written informed consent
The laboratory tests will be processed for the above mentioned serum markers of unstable plaque
A multivariate correlation test will be done between the different serum markers and the plaque morphology by angiography and composition virtual histology by IVUS
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