AtherosclerosisNCT00344292
Understanding the Genetic and Hereditary Basis of Atherosclerosis
An observational study of Atherosclerosis and Cardiovascular Diseases, run by Wake Forest University Health Sciences at 4 sites in United States.
Trial summary
Atherosclerosis is a condition that occurs when fatty deposits build up along the inner walls of arteries. New strategies are needed to prevent and treat atherosclerosis. The purpose of this study is to analyze the DNA of participants in two ongoing studies to identify genetic variations responsible for the… Read more about this study
- Who is it for?
- Ages 15 to 34 years
- Conditions the study is for
- Atherosclerosis, Cardiovascular Diseases
- How many people
- 2,763 participants
- Where
- 4 sitesUnited States
- Study dates
- Mar 2006to Feb 2012
- 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 15 to 34 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: Subject enrolled in the Pathobiologic Determinants of Atherosclerosis in Youth (PDAY) study
Who may be able to join
- Participant in PDAY or MESA
Who cannot join
None listed.
Trial locations and contacts
4 sites in 1 country.
United States4 sites
The University of Texas
Houston, Texas, 77225
Cedars-Sinai Health System
Los Angeles, California, 90048
Louisiana State University
New Orleans, Louisiana, 70112
University of Washington
Seattle, Washington, 98105
About this study
Official title: SNPs and Extent of Atherosclerosis (SEA) Study
Atherosclerosis is a condition that occurs when fatty deposits build up along the inner walls of arteries. New strategies are needed to prevent and treat atherosclerosis. The purpose of this study is to analyze the DNA of participants in two ongoing studies to identify genetic variations responsible for the development of atherosclerosis.
Read the detailed description
Atherosclerosis is a condition in which deposits of fat, cholesterol, and other substances build up along the inner walls of arteries; these deposits are known as plaque. As plaque builds up, it increases the risk of blood clots, heart attack, and stroke. Research has shown that the risk of developing atherosclerosis can be influenced by heredity. However, researchers have been unable to identify the specific genes associated with this risk. Single nucleotide polymorphisms (SNPs) are small genetic variations that can occur within an individual's DNA. In this study, researchers will analyze the DNA of many individuals for differences in SNP patterns. The goal of the study is to determine which SNP patterns are associated with the development of atherosclerosis. The data from this study may lead to new strategies for early identification of high risk individuals who may benefit from aggressive treatment to prevent the development of atherosclerosis.
This study will not recruit any new participants. DNA will be collected and analyzed from participants in two existing studies-the Pathobiological Determinants of Atherosclerosis in Youth (PDAY) study and the Multi-Ethnic Study of Atherosclerosis (MESA). DNA from the PDAY participants will be obtained from liver samples gathered during an autopsy following the participants' deaths; DNA from the MESA participants will be obtained from blood collected during routine study visits. There will be no additional study visits for participants, and all DNA samples and study information will be kept confidential. Genetic testing will be performed to determine the association between SNPs and subclinical atherosclerosis, which is a form of the condition prior to the onset of symptoms. The study will evaluate specific variations in SNPs and subclinical disease among different ethnic groups, which may help to explain why certain ethnic groups have higher rates of atherosclerosis. The study will also examine the association between SNPs and other indicators of subclinical and clinical atherosclerosis, including the thickness of arteries, heart calcium levels, and blood pressure levels.
- Conditions
- Atherosclerosis, Cardiovascular Diseases
- Keywords
- Polymorphism, Genetic, Coronary Artery Disease, Coronary Arteriosclerosis, Polymorphism, Single Nucleotide, SNPs
- Medical subject headings
- Atherosclerosis, Cardiovascular Diseases, Coronary Artery Disease
What is being measured
The primary outcome is the main question the study is designed to answer.
To estimate the association between common single nucleotide polymorphisms (SNPs) in the human genome and extent of subclinical atherosclerosis among subjects in the Pathobiological Determinants of Atherosclerosis in Youth (PDAY) cohort (N=2,876).
Measured: Entire project period.
To estimate the association between potential atherosclerosis SNPs identified in the PDAY cohort and extent of subclinical atherosclerosis among subjects in the Multi-Ethnic Study of Atherosclerosis (MESA) cohort (N=6,577).
Measured: Entire project period
To define the haplotypic structure of the genome in the regions of SNPs that are associated with atherosclerosis in PDAY and MESA and to perform additional genotyping necessary for haplotype association studies using both the PDAY and MESA cohorts.
Measured: Entire project period.
To disseminate the identity, location, primer sets and allele frequency of the atherosclerosis associated SNPs in PDAY, and those confirmed in MESA, in order to facilitate additional replication and functional studies of the most promising SNPs.
Measured: Entire project period.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jun 2006 (estimated)
- Study startMar 2006
- Primary completionFeb 2012
- Study completionFeb 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AtherosclerosisStudies of the same condition, open and under way.
- More trials run by Wake Forest University Health SciencesThe sponsor's other registered studies.
- 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
- Observational model
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 2,763 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wake Forest University Health Sciences
- Sponsor type
- University, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Responsible party
- Sponsor
- Investigators
- David M. Herrington, MD, MHS, Principal investigator, Wake Forest University Health Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00344292
- Sponsor's protocol ID
- 1333
- Other IDs
- U01HL080443-01A1, R01 HL080443-01A1
- Status last verified
- Mar 2017
- First submitted
- 23 Jun 2006
- Last updated
- 8 Nov 2017
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 8 Nov 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- SNPs and Extent of Atherosclerosis (SEA) Study
- ClinicalTrials.gov ID
- NCT00344292
- Acronym / sponsor ID
- 1333
- Conditions
- Atherosclerosis, Cardiovascular Diseases
- Keywords
- Polymorphism, Genetic, Coronary Artery Disease, Coronary Arteriosclerosis, Polymorphism, Single Nucleotide, SNPs
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 2,763 participants (actual)
- Lead sponsor
- Wake Forest University Health SciencesUniversity, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Study start
- Mar 2006
- Primary completion
- Feb 2012 (actual)
- Study completion
- Feb 2012 (actual)
- First posted
- 26 Jun 2006 (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 is a condition that occurs when fatty deposits build up along the inner walls of arteries. New strategies are needed to prevent and treat atherosclerosis. The purpose of this study is to analyze the DNA of participants in two ongoing studies to identify genetic variations responsible for the development of atherosclerosis.
Detailed description
Atherosclerosis is a condition in which deposits of fat, cholesterol, and other substances build up along the inner walls of arteries; these deposits are known as plaque. As plaque builds up, it increases the risk of blood clots, heart attack, and stroke. Research has shown that the risk of developing atherosclerosis can be influenced by heredity. However, researchers have been unable to identify the specific genes associated with this risk. Single nucleotide polymorphisms (SNPs) are small genetic variations that can occur within an individual's DNA. In this study, researchers will analyze the DNA of many individuals for differences in SNP patterns. The goal of the study is to determine which SNP patterns are associated with the development of atherosclerosis. The data from this study may lead to new strategies for early identification of high risk individuals who may benefit from aggressive treatment to prevent the development of atherosclerosis.
This study will not recruit any new participants. DNA will be collected and analyzed from participants in two existing studies-the Pathobiological Determinants of Atherosclerosis in Youth (PDAY) study and the Multi-Ethnic Study of Atherosclerosis (MESA). DNA from the PDAY participants will be obtained from liver samples gathered during an autopsy following the participants' deaths; DNA from the MESA participants will be obtained from blood collected during routine study visits. There will be no additional study visits for participants, and all DNA samples and study information will be kept confidential. Genetic testing will be performed to determine the association between SNPs and subclinical atherosclerosis, which is a form of the condition prior to the onset of symptoms. The study will evaluate specific variations in SNPs and subclinical disease among different ethnic groups, which may help to explain why certain ethnic groups have higher rates of atherosclerosis. The study will also examine the association between SNPs and other indicators of subclinical and clinical atherosclerosis, including the thickness of arteries, heart calcium levels, and blood pressure levels.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
Who may qualify
- Ages
- 15 to 34 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- Subject enrolled in the Pathobiologic Determinants of Atherosclerosis in Youth (PDAY) study
Key inclusion criteria (1 listed)
- Participant in PDAY or MESA
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
To estimate the association between common single nucleotide polymorphisms (SNPs) in the human genome and extent of subclinical atherosclerosis among subjects in the Pathobiological Determinants of Atherosclerosis in Youth (PDAY) cohort (N=2,876).
Time frame: Entire project period.
To estimate the association between potential atherosclerosis SNPs identified in the PDAY cohort and extent of subclinical atherosclerosis among subjects in the Multi-Ethnic Study of Atherosclerosis (MESA) cohort (N=6,577).
Time frame: Entire project period
To define the haplotypic structure of the genome in the regions of SNPs that are associated with atherosclerosis in PDAY and MESA and to perform additional genotyping necessary for haplotype association studies using both the PDAY and MESA cohorts.
Time frame: Entire project period.
To disseminate the identity, location, primer sets and allele frequency of the atherosclerosis associated SNPs in PDAY, and those confirmed in MESA, in order to facilitate additional replication and functional studies of the most promising SNPs.
Time frame: Entire project period.
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 8 Nov 2017.
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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.
David M. Herrington, MD, MHS principal investigator
Wake Forest University Health Sciences
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Atherosclerosis and Cardiovascular Diseases, run by Wake Forest University Health Sciences at 4 sites in United States.
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: finished, as of the sponsor's last update on 8 Nov 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites 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.
What does the primary outcome measure?
To estimate the association between common single nucleotide polymorphisms (SNPs) in the human genome and extent of subclinical atherosclerosis among subjects in the Pathobiological Determinants of Atherosclerosis in Youth (PDAY) cohort (N=2,876). (time frame: Entire project period.). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
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 8 Nov 2017.