Inflammatory Profiles of Children at High Risk for Atherosclerosis

Inflammation Clinical Trial

Official title:

Inflammatory Profiles of Children at High Risk for Atherosclerosis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00115232
• Other study ID #: 04-03-044
• Status: Completed
• Phase: N/A
• First received: June 21, 2005
• Last updated: January 14, 2008
• Start date: July 2004
• Est. completion date: March 2007

Study information

• Verified date: January 2008
• Source: Children's Hospital Boston
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial Summary

The purpose of this study is to evaluate levels of inflammatory mediators in children at risk for cardiovascular disease due to family history. We are measuring inflammatory markers in two groups of children and their parents: children with a family history of early atherosclerotic heart disease (cases), and healthy children without such a family history (controls). The design is a cross-sectional study, gathering a fasting blood sample and clinical and behavioral data on children and a parent.

Description:

Family history is a well known risk factor for early atherosclerosis. Whether inflammation plays a role in the increased risk of family history is not known. In this prospective single-center study, we are recruiting children with and without a family history of premature atherosclerotic disease, defined as occurring < 55 years in males and <65 years in females. Children are recruited primarily from a pediatric preventive cardiology clinic at Children's Hospital Boston. We measure anthropomorphic characteristics, fasting lipid profiles and inflammatory marker levels, including high sensitivity C-reactive protein (hsCRP), intracellular adhesion molecule 1 (ICAM-1), P-selectin, and tumor necrosis factor alpha receptor 2 (TNFαR2).

In this sample of high-risk overweight children, Lp(a) and inflammatory markers could reflect cardiovascular risk outside lipid profiles.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 300
• Est. completion date: March 2007
• Est. primary completion date: October 2006
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 8 Years to 21 Years

Eligibility

Inclusion Criteria:

• Age 8-21 years

• Parent able to participate

• Fasting state

• Live locally

Exclusion Criteria:

• Taking medication that may alter cholesterol levels or inflammatory state

• Past or present inflammatory illnesses

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Atherosclerosis
• Cardiovascular Disease
• Cardiovascular Diseases
• Hypercholesterolemia
• Inflammation
• Metabolic Syndrome X

Locations

Country	Name	City	State
United States	Children's Hospital Boston	Boston	Massachusetts

Sponsors (2)

Lead Sponsor	Collaborator
Children's Hospital Boston	Sandra A. Daugherty Foundation

Country where clinical trial is conducted

United States,