NCT00115232

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
300

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jul 2004

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2004

Completed
12 months until next milestone

First Submitted

Initial submission to the registry

June 21, 2005

Completed
1 day until next milestone

First Posted

Study publicly available on registry

June 22, 2005

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2006

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2007

Completed
Last Updated

January 16, 2008

Status Verified

January 1, 2008

Enrollment Period

2.3 years

First QC Date

June 21, 2005

Last Update Submit

January 14, 2008

Conditions

Cardiovascular DiseaseMetabolic Syndrome XHypercholesterolemiaInflammation

Keywords

cardiovascular diseasemetabolic syndromehypercholesterolemiachildfamily historyinflammation

Study Arms (4)

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

Eligibility Criteria

Age8 Years - 21 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Primarily children referred to preventive cardiology clinic.

You may qualify if:

  • Age 8-21 years
  • Parent able to participate
  • Fasting state
  • Live locally

You may not qualify if:

  • Taking medication that may alter cholesterol levels or inflammatory state
  • Past or present inflammatory illnesses

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Children's Hospital Boston

Boston, Massachusetts, 02115, United States

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Fasting serum samples, frozen.

MeSH Terms

Conditions

Cardiovascular DiseasesMetabolic SyndromeHypercholesterolemiaInflammation

Condition Hierarchy (Ancestors)

Insulin ResistanceHyperinsulinismGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesHyperlipidemiasDyslipidemiasLipid Metabolism DisordersPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Sarah D. de Ferranti, MD MPH

    Boston Children's Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER

Study Record Dates

First Submitted

June 21, 2005

First Posted

June 22, 2005

Study Start

July 1, 2004

Primary Completion

October 1, 2006

Study Completion

March 1, 2007

Last Updated

January 16, 2008

Record last verified: 2008-01

Locations

US(1)