Inflammatory Profiles of Children at High Risk for Atherosclerosis

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.

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Key information

Conditions

Cardiovascular Disease Cardiovascular Diseases Dyslipidemias Glucose Metabolism Disorders Hypercholesterolemia Hyperinsulinism Hyperlipidemias Inflammation Insulin Resistance Lipid Metabolism Disorders Metabolic Diseases Metabolic Syndrome Metabolic Syndrome X Nutritional and Metabolic Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

8 year–21 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Children's Hospital Boston

Boston, Massachusetts, 02115, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Sponsors and collaborators

Lead sponsor

Boston Children's Hospital

Other

Collaborators

Sandra A. Daugherty Foundation

Registry information

Important dates

Study start: 2004
Primary completion: 2006
Study completion: 2007
First posted: Jun 22, 2005
Registry last updated: Jan 16, 2008

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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