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The Correlation Between the Enzyme Paraoxigenase 1 (PON1) to Carotid Artery Atheromatous Plaque

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified December 2011 by yehudit.hackmon, Ziv Hospital.
Recruitment status was:  Recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT01440036
First Posted: September 23, 2011
Last Update Posted: December 16, 2011
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
yehudit.hackmon, Ziv Hospital
  Purpose
The objective of the research, is to examine the hypothesis, that the enzyme paraoxygenase 1 ( PON1) can influence carotid artery's atherosclerotic plaque content and stability, and its relation to plasma's enzyme concentration.

Condition Intervention
Carotid Artery Stenosis Procedure: Carotid endarterectomy

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: The Correlation Between the Enzyme Paraoxigenase 1 (PON1) to Carotid Artery Atheromatous Plaque

Further study details as provided by yehudit.hackmon, Ziv Hospital:

Biospecimen Retention:   Samples Without DNA
Atherosclerotic plaque from carotid arteries Blood sample (5cc)

Estimated Enrollment: 100
Study Start Date: October 2011
Estimated Study Completion Date: October 2014
Estimated Primary Completion Date: October 2012 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Carotid endarterectomy
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

Detailed Description:

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.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients undergoing CEA
Criteria

Inclusion Criteria:

  • Patients undergoing CEA
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01440036


Contacts
Contact: Tal Salamon, MD 972-50-8434185 tal.s@ziv.health.gov.il
Contact: Dallit Manheim, MD 972-50-6265752 DalitMa@clalit.org.il

Locations
Israel
Ziv Medical Center Recruiting
Safed, Israel
Contact: Tal Salamon, MD    972-50-8434185    tal.s@ziv.health.gov.il   
Contact: Dallit Manheim, MD    972-50-6265752    DalitMa@clalit.org.il   
Sponsors and Collaborators
Ziv Hospital
  More Information

Responsible Party: yehudit.hackmon, Principal Investigator, Ziv Hospital
ClinicalTrials.gov Identifier: NCT01440036     History of Changes
Other Study ID Numbers: 0032-11-ZIV
First Submitted: September 22, 2011
First Posted: September 23, 2011
Last Update Posted: December 16, 2011
Last Verified: December 2011

Keywords provided by yehudit.hackmon, Ziv Hospital:
carotid artery
Atherosclerotic plaque
paraoxygenase 1 PON1
Patients undergoing carotid artery endarterectomy CEA for carotid artery stenosis

Additional relevant MeSH terms:
Carotid Stenosis
Plaque, Atherosclerotic
Carotid Artery Diseases
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Arterial Occlusive Diseases
Vascular Diseases
Cardiovascular Diseases
Pathological Conditions, Anatomical