Inflammatory Profiles of Children at High Risk for Atherosclerosis

Completed

• Conditions: Inflammation; Cardiovascular Disease; Metabolic Syndrome X; Hypercholesterolemia

• Registration Number: NCT00115232
• Lead Sponsor: Boston Children's Hospital

Brief 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.

Detailed 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.

Study Timeline

• Study Start: 2004-07
• Study First Submitted: 2005-06-21
• Study First Submitted QC: 2005-06-21
• Study First Posted: 2005-06-22
• Primary Completion: 2006-10
• Study Completion: 2007-03
• Status Verified: 2008-01
• Last Update Submitted: 2008-01-14
• Last Update Posted: 2008-01-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 300

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Trial Locations

Locations (1)

Children's Hospital Boston; 🇺🇸 Boston, Massachusetts, United States