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

NCT00613158 | Completed DMC

• 2 other identifiers: 1384R01HL086678-01A1
• Study Type: observational
• Target: 120
• Locations: 1 country
• Sites: 1

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.

Conditions

Atherosclerosis; Cardiovascular Diseases

Keywords

Subclincal Atherosclerosis

Outcome Measures

Primary Outcomes (1)

• SA burden, as indicated by coronary artery calcium score and intima-medial thickness

  Measured at completion of sample analysis

Study Arms (3)

1

Participants from the Multi-Ethnic Study of Atherosclerosis (MESA) with significant subclinical atherosclerosis (SA) and a low Framingham risk score

2

Participants from MESA with no SA and a low Framingham risk score

3

Healthy participants from Northwestern University

Eligibility Criteria

• Age: 20 Years - 85 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• \- Diabetes

Sponsors & Collaborators

• National Heart, Lung, and Blood Institute (NHLBI): lead

Study Sites (1)

Northwestern University

Chicago, Illinois, 60611, United States

Location

MeSH Terms

Conditions

Atherosclerosis; Cardiovascular Diseases

Condition Hierarchy (Ancestors)

Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Study Officials

• Chiang-Ching Huang, PhD

  Northwestern University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: NIH

Study Record Dates

• First Submitted: February 8, 2008
• First Posted: February 12, 2008
• Study Start: March 1, 2007
• Primary Completion: August 1, 2007
• Study Completion: February 1, 2010
• Last Updated: July 29, 2016

Record last verified: 2009-04

Locations

US (1)