Inflammatory Profiles of Children at High Risk for Atherosclerosis

NCT ID: NCT00115232

Last Updated: 2008-01-16

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 300 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2004-07-31
• Study Completion Date: 2007-03-31

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.

Conditions

Cardiovascular Disease; Metabolic Syndrome X; Hypercholesterolemia; Inflammation

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

1

Children without family history of early atherosclerosis

No interventions assigned to this group

2

Children with family history of early atherosclerosis.

No interventions assigned to this group

3

Parents of children without family history of early atherosclerosis

No interventions assigned to this group

4

Parents of children with family history of early atherosclerosis

No interventions assigned to this group

Eligibility Criteria

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

• Minimum Eligible Age: 8 Years
• Maximum Eligible Age: 21 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Sandra A. Daugherty Foundation

OTHER

Sponsor Role: collaborator

Boston Children's Hospital

OTHER

Sponsor Role: lead

Responsible Party

Children's Hospital Boston

Principal Investigators

Sarah D. de Ferranti, MD MPH

Role: PRINCIPAL_INVESTIGATOR

Boston Children's Hospital

Locations

Children's Hospital Boston

Boston, Massachusetts, United States

Countries

United States

Other Identifiers

04-03-044

Identifier Type: -

Identifier Source: org_study_id