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Inflammatory Profiles of Children at High Risk for Atherosclerosis

Boston Children's Hospital logo

Boston Children's Hospital

Status

Completed

Conditions

Inflammation
Hypercholesterolemia
Metabolic Syndrome X
Cardiovascular Disease

Study type

Observational

Funder types

Other

Identifiers

NCT00115232
04-03-044

Details and patient eligibility

About

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.

Full 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.

Enrollment

300 patients

Sex

All

Ages

8 to 21 years old

Volunteers

Accepts Healthy Volunteers

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

Trial design

300 participants in 4 patient groups

1
Description:
Children without family history of early atherosclerosis
2
Description:
Children with family history of early atherosclerosis.
3
Description:
Parents of children without family history of early atherosclerosis
4
Description:
Parents of children with family history of early atherosclerosis

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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