NCT00344292

Brief 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 development of atherosclerosis.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
2,763

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Mar 2006

Longer than P75 for all trials

Geographic Reach
1 country

4 active sites

Status
completed

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

Study Start

First participant enrolled

March 1, 2006

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

June 23, 2006

Completed
3 days until next milestone

First Posted

Study publicly available on registry

June 26, 2006

Completed
5.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2012

Completed
Last Updated

November 8, 2017

Status Verified

March 1, 2017

Enrollment Period

5.9 years

First QC Date

June 23, 2006

Last Update Submit

November 6, 2017

Conditions

Keywords

Polymorphism, GeneticCoronary Artery DiseaseCoronary ArteriosclerosisPolymorphism, Single NucleotideSNPs

Outcome Measures

Primary Outcomes (4)

  • 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).

    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).

    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.

    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.

    Entire project period.

Eligibility Criteria

Age15 Years - 34 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • Participant in PDAY or MESA

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Cedars-Sinai Health System

Los Angeles, California, 90048, United States

Location

Louisiana State University

New Orleans, Louisiana, 70112, United States

Location

The University of Texas

Houston, Texas, 77225, United States

Location

University of Washington

Seattle, Washington, 98105, United States

Location

Biospecimen

Retention: SAMPLES WITH DNA

DNA

MeSH Terms

Conditions

AtherosclerosisCardiovascular DiseasesCoronary Artery Disease

Condition Hierarchy (Ancestors)

ArteriosclerosisArterial Occlusive DiseasesVascular DiseasesCoronary DiseaseMyocardial IschemiaHeart Diseases

Study Officials

  • David M. Herrington, MD, MHS

    Wake Forest University Health Sciences

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 23, 2006

First Posted

June 26, 2006

Study Start

March 1, 2006

Primary Completion

February 1, 2012

Study Completion

February 1, 2012

Last Updated

November 8, 2017

Record last verified: 2017-03

Locations