Inflammatory Profiles of Children at High Risk for Atherosclerosis

Sponsor

Boston Children's Hospital (Other)

Overall Status

Completed

CT.gov ID

NCT00115232

Collaborator

Sandra A. Daugherty Foundation (Other)

300

Enrollment

Location

Duration (Months)

9.4

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Cardiovascular Disease Metabolic Syndrome X Hypercholesterolemia Inflammation

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 Design

Study Type:

Observational

Actual Enrollment :

300 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

Inflammatory Profiles of Children at High Risk for Atherosclerosis

Study Start Date :

Jul 1, 2004

Actual Primary Completion Date :

Oct 1, 2006

Actual Study Completion Date :

Mar 1, 2007

Arms and Interventions

Arm	Intervention/Treatment
1 Children without family history of early atherosclerosis
2 Children with family history of early atherosclerosis.
3 Parents of children without family history of early atherosclerosis
4 Parents of children with family history of early atherosclerosis