The Correlation Between the Enzyme Paraoxigenase 1 (PON1) to Carotid Artery Atheromatous Plaque
|ClinicalTrials.gov Identifier: NCT01440036|
Recruitment Status : Unknown
Verified December 2011 by yehudit.hackmon, Ziv Hospital.
Recruitment status was: Recruiting
First Posted : September 23, 2011
Last Update Posted : December 16, 2011
|Condition or disease||Intervention/treatment|
|Carotid Artery Stenosis||Procedure: Carotid endarterectomy|
Atherosclerosis is a major risk factor for morbidity and mortality in the western world. It is characterized by the accumulation of fat (cholesterol) in the arterial wall, creation of the atheromatous plagues and the creation of arterial stenosis and occlusion. The cellular content of theses plaques include: fibroblasts, endothelial cells, smooth muscle cells, macrophages, and lipids: phospholipids, cholesterol, oxysterols and fatty acids. Lipids penetration from the blood stream collaborates different proteins, including the anti-atherogenic enzyme - paraoxygenase 1 - PON1. This enzyme has many ani-atherogenic activities, e.g. Protection from oxygenation and increase of cholesterol efflux from macrophages by HDL. Although the enzyme has a verity of substrates and known anti-atherogenous function, its mechanism is still vogue. The enzymes accumulation rate is the function of the advancement of the fatty strike towards advanced lesion. There is evidence that the presence accumulation and activity of the PON1 within the plaque, is a defense mechanism against atherosclerosis development. The assumption to be proved is that PON1 can control plaque's content and influence its atherogenous factors. Furthermore, we will try to identify these factors that the PON1 acts on. Beside plaque's content and PON1's influence on them, we would like to investigate the phenotype of haptoglobin in the subjects that the plaques were removed from. It is known that diabetics that have the genotype haptoglobin 2-2, characterized by increased risk for oxygenation stress and cardiovascular events (up to 5 times). We would like to examine if there is a correlation between plaque's content, PON1's ability to disassemble oxygenized factors within the plaque, and the phenotype to haptoglobin.
Methods: The plaque source will be from carotid endarterectomy, in the vascular unit. This procedure is a routine operation for patients suffering from carotid artery stenosis, based on clinical decisions. The plaques will be transported to a lipid laboratory soon after they will be harvested, will be frozen in liquid nitrogen and processed into powder. This material will be the origin for the proteins we try to extract. Patient's blood samples (that is drawn routinely for the operation) will be the source for the characterization of the haptoglobin's genotype.
It is critical to emphasize that routinely, the plaques are waste products, and only 5 cc of additional blood is withdrawn from the patients for research purposes.
|Study Type :||Observational|
|Estimated Enrollment :||100 participants|
|Observational Model:||Case Control|
|Official Title:||The Correlation Between the Enzyme Paraoxigenase 1 (PON1) to Carotid Artery Atheromatous Plaque|
|Study Start Date :||October 2011|
|Estimated Primary Completion Date :||October 2012|
|Estimated Study Completion Date :||October 2014|
Patients that have the common indication for the treatment of carotid artery stenosis by surgery - CEA (carotid endarterectomy), symptomatic and asymptomatic patients.
Procedure: Carotid endarterectomy
The removal of atherosclerotic plaque from the carotid artery, by surgery
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01440036
|Contact: Tal Salamon, MDemail@example.com|
|Contact: Dallit Manheim, MD||972-50-6265752||DalitMa@clalit.org.il|
|Ziv Medical Center||Recruiting|
|Contact: Tal Salamon, MD 972-50-8434185 firstname.lastname@example.org|
|Contact: Dallit Manheim, MD 972-50-6265752 DalitMa@clalit.org.il|