Inflammatory Profiles of Children at High Risk for Atherosclerosis

This study has been completed.
Sponsor:
Collaborator:
Sandra A. Daugherty Foundation
Information provided by:
Children's Hospital Boston
ClinicalTrials.gov Identifier:
NCT00115232
First received: June 21, 2005
Last updated: January 14, 2008
Last verified: January 2008
  Purpose

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
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 Children's Hospital Boston:

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)
Groups/Cohorts
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

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.

  Eligibility

Ages Eligible for Study:   8 Years to 21 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

Primarily children referred to preventive cardiology clinic.

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
  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 ClinicalTrials.gov identifier: NCT00115232

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

No publications provided

Responsible Party: Sarah de Ferranti, MD MPH, Children's Hospital Boston
ClinicalTrials.gov Identifier: NCT00115232     History of Changes
Other Study ID Numbers: 04-03-044
Study First Received: June 21, 2005
Last Updated: January 14, 2008
Health Authority: United States: Institutional Review Board

Keywords provided by Children's Hospital Boston:
cardiovascular disease
metabolic syndrome
hypercholesterolemia
child
family history
inflammation

Additional relevant MeSH terms:
Atherosclerosis
Cardiovascular Diseases
Hypercholesterolemia
Inflammation
Metabolic Syndrome X
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Hyperlipidemias
Dyslipidemias
Lipid Metabolism Disorders
Metabolic Diseases
Pathologic Processes
Insulin Resistance
Hyperinsulinism
Glucose Metabolism Disorders

ClinicalTrials.gov processed this record on July 22, 2014