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Using Differences in Peripheral Blood Leukocyte Gene Expression to Determine Cardiovascular Disease Risk

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ClinicalTrials.gov Identifier: NCT00613158
Recruitment Status : Completed
First Posted : February 12, 2008
Last Update Posted : July 29, 2016
Information provided by:

Study Description
Brief Summary:
Cardiovascular disease (CVD), including heart disease, heart attack, high blood pressure, and stroke, is most commonly caused by atherosclerosis, or a hardening of the arteries. Traditional risk factors for CVD include age, high blood pressure, high cholesterol, diabetes, and smoking. Although these established risk factors can be helpful in determining people at risk for developing CVD, the addition of novel gene markers for subclinical, or suspected, atherosclerosis (SA) may enhance CVD risk prediction and understanding of disease mechanisms. This study will compare specific genes of white blood cells in people with significant SA versus people without SA to improve identification of those at risk for developing CVD and to better understand the biological basis of SA.

Condition or disease
Atherosclerosis Cardiovascular Diseases

Detailed Description:

CVD is the leading cause of death worldwide and accounts for almost 40% of deaths each year in the United States. In a person with CVD, oxygenated blood is not adequately distributed throughout the body because of impaired function in the heart and blood vessels. This restricted blood flow can eventually lead to organ damage, heart attack, and stroke. Risk prediction for CVD, which is largely associated with SA, relies on the use of certain traditional risk factors. The widely used Framingham risk score (FRS) has provided excellent risk discrimination and reliable estimates of 10-year risk for CVD, but it does not account for the genetics behind SA. Although numerous studies have investigated novel genetic biomarkers to attempt to add predictive value to the FRS, no single biomarker to date has been able to improve risk prediction in a meaningful way. A multi-marker approach that identifies several novel markers unrelated to traditional risk factors may be more effective in improving the identification of those at risk for CVD. This study will first construct a multi-marker approach that is based on patterns of gene expression in peripheral blood leukocytes (PBLs) and that can serve to identify people with substantial SA. The study will then use this approach to determine whether gene expression patterns of PBLs in people with SA are distinct from those in people without SA.

This study will use previously collected data and specimens, including blood samples and SA imaging, from participants in the Multi-Ethnic Study of Atherosclerosis (MESA) trial and from healthy female participants from Northwestern University. Blood samples will be used for analysis of patterns of gene expression in PBLs. There will be no new study visits for this study.

The study completion date listed in this record was obtained from the "Completed Date" entered in the Query View Report System (QVR).

Study Design

Study Type : Observational
Actual Enrollment : 120 participants
Observational Model: Case Control
Time Perspective: Cross-Sectional
Official Title: Atherosclerosis Risk Refinement - a Multi-marker Approach Using Microarrays
Study Start Date : March 2007
Primary Completion Date : August 2007
Study Completion Date : February 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Atherosclerosis
U.S. FDA Resources

Groups and Cohorts

Participants from the Multi-Ethnic Study of Atherosclerosis (MESA) with significant subclinical atherosclerosis (SA) and a low Framingham risk score
Participants from MESA with no SA and a low Framingham risk score
Healthy participants from Northwestern University

Outcome Measures

Primary Outcome Measures :
  1. SA burden, as indicated by coronary artery calcium score and intima-medial thickness [ Time Frame: Measured at completion of sample analysis ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 85 Years   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
This study will include female participants from MESA with and without SA. This study will also include healthy female participants from Northwestern University.

Inclusion Criteria:

  • Female participant from the MESA study who has a low Framingham risk score and has either SA or no evidence of SA
  • Healthy female below the age of 40 from Northwestern University.

Exclusion Criteria:

- Diabetes

Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00613158

United States, Illinois
Northwestern University
Chicago, Illinois, United States, 60611
Sponsors and Collaborators
National Heart, Lung, and Blood Institute (NHLBI)
Principal Investigator: Chiang-Ching Huang, PhD Northwestern University
More Information

Responsible Party: Chiang-Ching Huang, PhD, Northwestern University
ClinicalTrials.gov Identifier: NCT00613158     History of Changes
Other Study ID Numbers: 1384
R01HL086678-01A1 ( U.S. NIH Grant/Contract )
First Posted: February 12, 2008    Key Record Dates
Last Update Posted: July 29, 2016
Last Verified: April 2009

Keywords provided by National Heart, Lung, and Blood Institute (NHLBI):
Subclincal Atherosclerosis

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