Ignite Creation Date:
2025-12-24 @ 9:30 PM
Ignite Modification Date:
2026-02-01 @ 7:18 PM
Study NCT ID:
NCT00115232
Status:
COMPLETED
Last Update Posted:
2008-01-16
First Post:
2005-06-21
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Inflammatory Profiles of Children at High Risk for Atherosclerosis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D024821', 'term': 'Metabolic Syndrome'}, {'id': 'D006937', 'term': 'Hypercholesterolemia'}, {'id': 'D007249', 'term': 'Inflammation'}], 'ancestors': [{'id': 'D007333', 'term': 'Insulin Resistance'}, {'id': 'D006946', 'term': 'Hyperinsulinism'}, {'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D006949', 'term': 'Hyperlipidemias'}, {'id': 'D050171', 'term': 'Dyslipidemias'}, {'id': 'D052439', 'term': 'Lipid Metabolism Disorders'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITHOUT_DNA', 'description': 'Fasting serum samples, frozen.'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 300}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2004-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2008-01', 'completionDateStruct': {'date': '2007-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2008-01-14', 'studyFirstSubmitDate': '2005-06-21', 'studyFirstSubmitQcDate': '2005-06-21', 'lastUpdatePostDateStruct': {'date': '2008-01-16', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2005-06-22', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2006-10', 'type': 'ACTUAL'}}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['cardiovascular disease', 'metabolic syndrome', 'hypercholesterolemia', 'child', 'family history', 'inflammation'], 'conditions': ['Cardiovascular Disease', 'Metabolic Syndrome X', 'Hypercholesterolemia', 'Inflammation']}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': "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).\n\nIn this sample of high-risk overweight children, Lp(a) and inflammatory markers could reflect cardiovascular risk outside lipid profiles."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '21 Years', 'minimumAge': '8 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Primarily children referred to preventive cardiology clinic.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age 8-21 years\n* Parent able to participate\n* Fasting state\n* Live locally\n\nExclusion Criteria:\n\n* Taking medication that may alter cholesterol levels or inflammatory state\n* Past or present inflammatory illnesses'}, 'identificationModule': {'nctId': 'NCT00115232', 'briefTitle': 'Inflammatory Profiles of Children at High Risk for Atherosclerosis', 'organization': {'class': 'OTHER', 'fullName': "Boston Children's Hospital"}, 'officialTitle': 'Inflammatory Profiles of Children at High Risk for Atherosclerosis', 'orgStudyIdInfo': {'id': '04-03-044'}}, 'armsInterventionsModule': {'armGroups': [{'label': '1', 'description': 'Children without family history of early atherosclerosis'}, {'label': '2', 'description': 'Children with family history of early atherosclerosis.'}, {'label': '3', 'description': 'Parents of children without family history of early atherosclerosis'}, {'label': '4', 'description': 'Parents of children with family history of early atherosclerosis'}]}, 'contactsLocationsModule': {'locations': [{'zip': '02115', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': "Children's Hospital Boston", 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}], 'overallOfficials': [{'name': 'Sarah D. de Ferranti, MD MPH', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "Boston Children's Hospital"}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Boston Children's Hospital", 'class': 'OTHER'}, 'collaborators': [{'name': 'Sandra A. Daugherty Foundation', 'class': 'OTHER'}], 'responsibleParty': {'oldNameTitle': 'Sarah de Ferranti, MD MPH', 'oldOrganization': "Children's Hospital Boston"}}}}