NCT01440036

Brief 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Oct 2011

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 22, 2011

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 23, 2011

Completed
8 days until next milestone

Study Start

First participant enrolled

October 1, 2011

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2012

Completed
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2014

Completed
Last Updated

December 16, 2011

Status Verified

December 1, 2011

Enrollment Period

1 year

First QC Date

September 22, 2011

Last Update Submit

December 15, 2011

Conditions

Carotid Artery Stenosis

Keywords

carotid arteryAtherosclerotic plaqueparaoxygenase 1 PON1Patients undergoing carotid artery endarterectomy CEA for carotid artery stenosis

Study Arms (1)

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

Interventions

Carotid endarterectomyPROCEDURE

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

Carotid endarterectomy

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients undergoing CEA

You may qualify if:

  • Patients undergoing CEA

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ziv Medical Center

Safed, Israel, Israel

RECRUITING

Biospecimen

Retention: SAMPLES WITHOUT DNA

Atherosclerotic plaque from carotid arteries Blood sample (5cc)

MeSH Terms

Conditions

Carotid StenosisPlaque, Atherosclerotic

Interventions

Endarterectomy, Carotid

Condition Hierarchy (Ancestors)

Carotid Artery DiseasesCerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesArterial Occlusive DiseasesVascular DiseasesCardiovascular DiseasesPathological Conditions, AnatomicalPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

EndarterectomyVascular Surgical ProceduresCardiovascular Surgical ProceduresSurgical Procedures, Operative

Central Study Contacts

Tal Salamon, MD

CONTACT

972-50-8434185tal.s@ziv.health.gov.il

Dallit Manheim, MD

CONTACT

972-50-6265752DalitMa@clalit.org.il

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

September 22, 2011

First Posted

September 23, 2011

Study Start

October 1, 2011

Primary Completion

October 1, 2012

Study Completion

October 1, 2014

Last Updated

December 16, 2011

Record last verified: 2011-12

Locations

IL(1)