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Carotid Artery StenosisNCT01440036

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

An observational study of Carotid Artery Stenosis, run by Ziv Hospital at 1 site in Israel.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Carotid Artery Stenosis
What is being tested?
Carotid endarterectomy
Type of treatment
Surgery or procedure
How many people
100 participants
Where
1 siteIsrael
Study dates
Oct 2011to Oct 2014
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 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: Patients undergoing CEA

Who may be able to join

  • Patients undergoing CEA

Who cannot join

None listed.

Trial locations and contacts

1 site in 1 country.

Dallit Manheim, MD contact

972-50-6265752

DalitMa@clalit.org.il

Israel1 site, 1 recruiting
  • Ziv Medical Center

    Safed, Israel

    Tal Salamon, MD, 972-50-8434185, tal.s@ziv.health.gov.il

    Dallit Manheim, MD, 972-50-6265752, DalitMa@clalit.org.il

    Recruiting

Other trials in Israel

About this study

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.

Read the 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.

Being tested
Carotid endarterectomy
Keywords
carotid artery, Atherosclerotic plaque, paraoxygenase 1 PON1, Patients undergoing carotid artery endarterectomy CEA for carotid artery stenosis
Medical subject headings
Carotid Stenosis, Plaque, Atherosclerotic

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Carotid endarterectomyProcedure or surgery

    The removal of atherosclerotic plaque from the carotid artery, by surgery

Study groups in NCT01440036
Study groupRoleWhat they receive
Carotid endarterectomyPatients that have the common indication for the treatment of carotid artery stenosis by surgery - CEA (carotid endarterectomy), symptomatic and asymptomatic patients.
Receives: Procedure: Carotid endarterectomy

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted23 Sep 2011 (estimated)
  2. Study startOct 2011
  3. Primary completionOct 2012 (estimated)
  4. Study completionOct 2014 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Case-control
Time perspective
Prospective
Enrolment
100 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01440036
Sponsor's protocol ID
0032-11-ZIV
Status last verified
Dec 2011
First submitted
22 Sep 2011
Last updated
16 Dec 2011
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

An observational study of Carotid Artery Stenosis, run by Ziv Hospital at 1 site in Israel.

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 1 inclusion and 0 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: status not confirmed, as of the sponsor's last update on 16 Dec 2011. 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 Israel. 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?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Tal Salamon, MD (972-50-8434185, tal.s@ziv.health.gov.il), or a site near the patient. AzTrials does not enrol participants or take referrals.

Where can I read the original study information?
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 16 Dec 2011.

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