NCT00011258

Brief Summary

Atherosclerosis of the carotid arteries is a common cause of stroke. The prevalence and progression of carotid atherosclerosis are believed to be influenced by genetically inherited variations in lipoprotein metabolism. This study investigates the specific role of paraoxonase, an enzyme thought to detoxify atherogenic oxidized low-density lipoprotein. This study compares veterans who have significant carotid atherosclerosis on ultrasound examination with controls without carotid atherosclerosis. Both paraoxonase activity and genotype will be determined and compared between groups. The results may eventually make it possible to screen for a paraoxonase allele that confers high risk of atherosclerosis, and to diminish the risk by early treatment.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
1,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Mar 1997

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 1997

Completed
4 years until next milestone

First Submitted

Initial submission to the registry

February 14, 2001

Completed
2 days until next milestone

First Posted

Study publicly available on registry

February 16, 2001

Completed
2.5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2003

Completed
Last Updated

January 21, 2009

Status Verified

January 1, 2004

First QC Date

February 14, 2001

Last Update Submit

January 20, 2009

Conditions

Carotid Stenosis

Keywords

Atherosclerosis of the carotid arteriesstrokelipoprotein metabolismparaoxonase

Interventions

ParaoxonaseDRUG

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Case: Either had a history of surgical carotid endarterectomy or carotid or CT angiogram showing greater than or equal to 80% stenosis in one or more internal carotid artery. Control: An ultrasound documenting internal carotid artery stenosis less than 15% bilaterally.

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (1)

VA Puget Sound Health Care System

Seattle, Washington, United States

Location

MeSH Terms

Conditions

Carotid StenosisStroke

Interventions

Aryldialkylphosphatase

Condition Hierarchy (Ancestors)

Carotid Artery DiseasesCerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesArterial Occlusive DiseasesVascular DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

Phosphoric Triester HydrolasesEsterasesHydrolasesEnzymesEnzymes and Coenzymes

Study Design

Study Type
observational
Sponsor Type
FED

Study Record Dates

First Submitted

February 14, 2001

First Posted

February 16, 2001

Study Start

March 1, 1997

Study Completion

September 1, 2003

Last Updated

January 21, 2009

Record last verified: 2004-01

Locations

US(1)