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Inflammatory Profiles of Children at High Risk for Atherosclerosis

This study has been completed.
Sandra A. Daugherty Foundation
Information provided by:
Boston Children’s Hospital Identifier:
First received: June 21, 2005
Last updated: January 14, 2008
Last verified: January 2008
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.

Cardiovascular Disease Metabolic Syndrome X Hypercholesterolemia Inflammation

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Inflammatory Profiles of Children at High Risk for Atherosclerosis

Resource links provided by NLM:

Further study details as provided by Boston Children’s Hospital:

Biospecimen Retention:   Samples Without DNA
Fasting serum samples, frozen.

Enrollment: 300
Study Start Date: July 2004
Study Completion Date: March 2007
Primary Completion Date: October 2006 (Final data collection date for primary outcome measure)
Children without family history of early atherosclerosis
Children with family history of early atherosclerosis.
Parents of children without family history of early atherosclerosis
Parents of children with family history of early atherosclerosis

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.


Ages Eligible for Study:   8 Years to 21 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Primarily children referred to preventive cardiology clinic.

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00115232

United States, Massachusetts
Children's Hospital Boston
Boston, Massachusetts, United States, 02115
Sponsors and Collaborators
Boston Children’s Hospital
Sandra A. Daugherty Foundation
Principal Investigator: Sarah D. de Ferranti, MD MPH Boston Children’s Hospital
  More Information

Responsible Party: Sarah de Ferranti, MD MPH, Children's Hospital Boston Identifier: NCT00115232     History of Changes
Other Study ID Numbers: 04-03-044
Study First Received: June 21, 2005
Last Updated: January 14, 2008

Keywords provided by Boston Children’s Hospital:
cardiovascular disease
metabolic syndrome
family history

Additional relevant MeSH terms:
Cardiovascular Diseases
Metabolic Syndrome X
Pathologic Processes
Insulin Resistance
Glucose Metabolism Disorders
Metabolic Diseases
Arterial Occlusive Diseases
Vascular Diseases
Lipid Metabolism Disorders processed this record on September 20, 2017