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Understanding the Genetic and Hereditary Basis of Atherosclerosis

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
david herrington, Wake Forest University Baptist Medical Center
ClinicalTrials.gov Identifier:
NCT00344292
First received: June 23, 2006
Last updated: January 23, 2013
Last verified: January 2013
  Purpose

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.


Condition
Atherosclerosis
Cardiovascular Diseases

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Retrospective
Official Title: SNPs and Extent of Atherosclerosis (SEA) Study

Resource links provided by NLM:


Further study details as provided by Wake Forest Baptist Health:

Primary Outcome Measures:
  • 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. ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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. ] [ Designated as safety issue: No ]
  • 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. ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples With DNA

DNA


Enrollment: 2763
Study Start Date: March 2006
Study Completion Date: February 2012
Primary Completion Date: February 2012 (Final data collection date for primary outcome measure)
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.

  Eligibility

Ages Eligible for Study:   15 Years to 34 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Subject enrolled in the Pathobiologic Determinants of Atherosclerosis in Youth (PDAY) study

Criteria

Inclusion Criteria:

  • Participant in PDAY or MESA
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00344292

Locations
United States, California
Cedars-Sinai Health System
Los Angeles, California, United States, 90048
United States, Louisiana
Louisiana State University
New Orleans, Louisiana, United States, 70112
United States, Texas
The University of Texas
Houston, Texas, United States, 77225
United States, Washington
University of Washington
Seattle, Washington, United States, 98105
Sponsors and Collaborators
Wake Forest Baptist Health
Investigators
Principal Investigator: David M. Herrington, MD, MHS Wake Forest School of Medicine
  More Information

No publications provided

Responsible Party: david herrington, Professor, Internal Medicine, Wake Forest University Baptist Medical Center
ClinicalTrials.gov Identifier: NCT00344292     History of Changes
Other Study ID Numbers: 1333, U01HL080443-01A1, R01 HL080443-01A1
Study First Received: June 23, 2006
Last Updated: January 23, 2013
Health Authority: United States: Federal Government

Keywords provided by Wake Forest Baptist Health:
Polymorphism, Genetic
Coronary Artery Disease
Coronary Arteriosclerosis
Polymorphism, Single Nucleotide
SNPs

Additional relevant MeSH terms:
Arteriosclerosis
Atherosclerosis
Cardiovascular Diseases
Arterial Occlusive Diseases
Vascular Diseases

ClinicalTrials.gov processed this record on November 23, 2014