Carotid StenosisNCT00011258
Paraoxonase and LDL Oxidation in Carotid Artery Disease
An observational study of Carotid Stenosis, run by US Department of Veterans Affairs at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Carotid Stenosis
- What is being tested?
- Paraoxonase
- How many people
- 1,000 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 1997to Sep 2003
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
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.
Trial locations and contacts
1 site in 1 country.
United States1 site
VA Puget Sound Health Care System
Seattle, Washington
About this study
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.
Read the detailed description
Primary Objective:
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.
Study Abstract:
The general aim of the proposed research is to evaluate the contribution and mechanism of paraoxonase (PON1) genotypic and phenotypic variation (PON1 status) in risk and progression of carotid artery disease (CAAD). We propose to study moderately affected individuals currently being enrolled in a longitudinal, 3-year magnetic resonance imaging (MR) study to evaluate components of MR image as predictors of CAAD progression. We will study the role of PON1 in CAAD progression in this cohort. We will also collect age-, sex-, race-, and hospital- matched controls, to test hypotheses related to the presence or absence of CAAD. We plan to consider the complex genetic architecture of both vascular disease and PON1 effects in vascular disease. In addition to evaluating known paraoxonase (PON1) polymorphisms, we will evaluate PON1 hydrolysis phenotypes. We have shown that these intervening phenotypes can be superior to known genotypes in CAAD prediction. We will also evaluate PON1 polymorphisms that we have recently detected and shown to affect PON1 expression, as well as consider haplotype effects. The specific aims are to: 1) test for PON1 effects in CAAD progression evaluated by 3 year magnetic resonance image follow-up of percent lumen stenosis; 2) test for PON1 effects in moderate CAAD vs. control prediction, including independence of PON1 from traditional cardiovascular risk factors; and 3) evaluate the possible mechanisms of PON1's association with carotid artery disease, specifically PON1's relationship with the susceptibility of LDL to oxidation and variation in LDL density.
Two paraoxonase (PON1) polymorphisms, PON1-Q192R and PON1-L55M have been inconsistently associated with vascular disease. However, plasma PON1 activity phenotypes vary markedly within genotypes. Thus, activity was expected to add to the informativeness of genotype for predicting vascular disease. The case-control study included 212 age and race matched men with mean age 66.4 yr. (range 49-82 yr.); 95% were Caucasian. The 106 carotid artery disease (CAAD) cases had >80% carotid stenosis and the 106 controls had <15% stenosis. Two PON1 substrate hydrolysis rates (paraoxon, POase; diazoxon, DZOase) were significantly lower in cases than in controls and were significant predictors of CAAD using logistic regression (POase, p=0.005, 25% reduced; DZOase, p=0.019, 16% reduced). POase and DZOase were both significant when included in the same model. DZOase predicted vascular disease independently of lipoprotein profile, HDL subfractions, apoAI, and smoking. The marginal effects of PON1-192 (p=0.75) and PON1-55 (p=0.83) genotypes or haplotype (0.70) did not predict case-control status. However, when phenotype was included as a predictor both PON1-192 and PON1-55 genotypes or haplotypes were significant predictors at the 0.05 level. The common methodology of examining PON1-192 and/or PON1-55 genotypes alone may lead to the erroneous conclusion that there is no PON1 role in CAAD. This may have broad implications for the utility of the "genotype only" approach. These results support the benefit of a "level crossing" approach that includes intervening phenotypes in the study of complexly inherited disease
- Conditions
- Carotid Stenosis
- Being tested
- Paraoxonase
- Keywords
- Atherosclerosis of the carotid arteries, stroke, lipoprotein metabolism, paraoxonase
- Medical subject headings
- Carotid Stenosis, Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ParaoxonaseDrug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Feb 2001 (estimated)
- Study startMar 1997
- Study completionSep 2003
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Carotid StenosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Enrolment
- 1,000 participants
Sponsor and investigators
- Lead sponsor
- US Department of Veterans Affairs
- Sponsor type
- US federal agency
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00011258
- Sponsor's protocol ID
- S006
- Status last verified
- Jan 2004
- First submitted
- 14 Feb 2001
- Last updated
- 21 Jan 2009
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Jan 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Paraoxonase and LDL Oxidation in Carotid Artery Disease
- ClinicalTrials.gov ID
- NCT00011258
- Acronym / sponsor ID
- S006
- Conditions
- Carotid Stenosis
- Keywords
- Atherosclerosis of the carotid arteries, stroke, lipoprotein metabolism, paraoxonase
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,000 participants
- Lead sponsor
- US Department of Veterans AffairsUS federal agency
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Study start
- Mar 1997
- Study completion
- Sep 2003
- First posted
- 16 Feb 2001 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Primary Objective:
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.
Study Abstract:
The general aim of the proposed research is to evaluate the contribution and mechanism of paraoxonase (PON1) genotypic and phenotypic variation (PON1 status) in risk and progression of carotid artery disease (CAAD). We propose to study moderately affected individuals currently being enrolled in a longitudinal, 3-year magnetic resonance imaging (MR) study to evaluate components of MR image as predictors of CAAD progression. We will study the role of PON1 in CAAD progression in this cohort. We will also collect age-, sex-, race-, and hospital- matched controls, to test hypotheses related to the presence or absence of CAAD. We plan to consider the complex genetic architecture of both vascular disease and PON1 effects in vascular disease. In addition to evaluating known paraoxonase (PON1) polymorphisms, we will evaluate PON1 hydrolysis phenotypes. We have shown that these intervening phenotypes can be superior to known genotypes in CAAD prediction. We will also evaluate PON1 polymorphisms that we have recently detected and shown to affect PON1 expression, as well as consider haplotype effects. The specific aims are to: 1) test for PON1 effects in CAAD progression evaluated by 3 year magnetic resonance image follow-up of percent lumen stenosis; 2) test for PON1 effects in moderate CAAD vs. control prediction, including independence of PON1 from traditional cardiovascular risk factors; and 3) evaluate the possible mechanisms of PON1's association with carotid artery disease, specifically PON1's relationship with the susceptibility of LDL to oxidation and variation in LDL density.
Two paraoxonase (PON1) polymorphisms, PON1-Q192R and PON1-L55M have been inconsistently associated with vascular disease. However, plasma PON1 activity phenotypes vary markedly within genotypes. Thus, activity was expected to add to the informativeness of genotype for predicting vascular disease. The case-control study included 212 age and race matched men with mean age 66.4 yr. (range 49-82 yr.); 95% were Caucasian. The 106 carotid artery disease (CAAD) cases had >80% carotid stenosis and the 106 controls had <15% stenosis. Two PON1 substrate hydrolysis rates (paraoxon, POase; diazoxon, DZOase) were significantly lower in cases than in controls and were significant predictors of CAAD using logistic regression (POase, p=0.005, 25% reduced; DZOase, p=0.019, 16% reduced). POase and DZOase were both significant when included in the same model. DZOase predicted vascular disease independently of lipoprotein profile, HDL subfractions, apoAI, and smoking. The marginal effects of PON1-192 (p=0.75) and PON1-55 (p=0.83) genotypes or haplotype (0.70) did not predict case-control status. However, when phenotype was included as a predictor both PON1-192 and PON1-55 genotypes or haplotypes were significant predictors at the 0.05 level. The common methodology of examining PON1-192 and/or PON1-55 genotypes alone may lead to the erroneous conclusion that there is no PON1 role in CAAD. This may have broad implications for the utility of the "genotype only" approach. These results support the benefit of a "level crossing" approach that includes intervening phenotypes in the study of complexly inherited disease
Study design
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Paraoxonase | Drug | – |
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jan 2009.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Carotid Stenosis, run by US Department of Veterans Affairs at 1 site in United States.
The full registered description is in the About this study section and the official record.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Jan 2009. 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 United States. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. 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 21 Jan 2009.