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Inflammatory Profiles of Children at High Risk for Atherosclerosis

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ClinicalTrials.gov Identifier: NCT00115232
Recruitment Status : Completed
First Posted : June 22, 2005
Last Update Posted : January 16, 2008
Sponsor:
Collaborator:
Sandra A. Daugherty Foundation
Information provided by:
Boston Children’s Hospital

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.

Condition or disease
Cardiovascular Disease Metabolic Syndrome X Hypercholesterolemia Inflammation

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.


Study Type : Observational
Actual Enrollment : 300 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Inflammatory Profiles of Children at High Risk for Atherosclerosis
Study Start Date : July 2004
Actual Primary Completion Date : October 2006
Actual Study Completion Date : March 2007

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Atherosclerosis
U.S. FDA Resources

Group/Cohort
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



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


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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.
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00115232


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

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
First Posted: June 22, 2005    Key Record Dates
Last Update Posted: January 16, 2008
Last Verified: January 2008

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

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