Viewing Study NCT00005397



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Last Modification Date: 2024-10-26 @ 9:05 AM
Study NCT ID: NCT00005397
Status: COMPLETED
Last Update Posted: 2017-06-12
First Post: 2000-05-25

Brief Title: Epidemiology of Carotid Artery Atherosclerosis in Youth
Sponsor: Patricia H Davis
Organization: University of Iowa

Study Overview

Official Title: None
Status: COMPLETED
Status Verified Date: 2017-06
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: None
Brief Summary: To examine the relationship of risk factors measured in childhood to intimal medial thickness IMT in early adulthood and to examine familial factors which may be related to increased IMT a measure of atherosclerosis
Detailed Description: BACKGROUND

The atherosclerotic process begins in childhood and advances through adult life when occlusive vascular disease results in coronary heart disease stroke and peripheral vascular disease Although risk factors have been established in adult populations risk factors when measured in childhood have not been directly related to morbidity and mortality from occlusive atherosclerotic disease The ultrasonographic measurement of carotid artery intimal-medial thickness IMT in adults is related not only to the risk for stroke but also to the severity of atherosclerotic disease in the coronary arteries In 1970 a population of school age children and adolescents was first examined in Muscatine Iowa and since then has been followed to examine the predictive value of childhood risk factor levels for cardiovascular disease See also Study 906 Muscatine Heart Study

The study will provide a view of the significance of IMT in young adults not only in its relationship to risk factors in childhood and young adulthood but also to familial factors that may be responsible for accelerated atherosclerosis

DESIGN NARRATIVE

Beginning in 1995 the longitudinal study examined the following 1 the relationship of body mass index BMI blood pressure total cholesterol and smoking behaviors measured in childhood to IMT measured in early adulthood 2 the relationship of risk factors BMI blood pressure total cholesterol LDL-C HDL-C Apo A1 Apo B Lpa Apo E genotypes glucose insulin and smoking to IMT in young adults 3 the relationship of risk factor load from childhood to adult life to IMT 4 the relationship of IMT in young adults to familial mortality in first- and second-degree relatives due to vascular disease and 5 the degree of familial aggregation of IMT in young adults and their parents

The study was renewed in FY 2000 to investigate the third generation of the Muscatine Heart Study cohort The renewal determined whether the offspring of cohort members with premature atherosclerosis or a familial history of cardiovascular disease had increased carotid intimal-medial thickness IMT or elevated risk factors identify risk factors for progression of carotid IMT and measure putative riskfactors for increased IMT serologic evidence of Chlamydia pneumoniae or cytomegalovirus infection high sensitivity C-reactive protein fibrinogen plasminogen activator inhibitor-1 and glycosylated hemoglobin

The study was extended through June 2008 to measure intimal-medial thickness in a vascular bed affected earlier by atherosclerosis the distal abdominal aorta as well as in the carotid artery In 662 offspring aged 11 to 32 years the investigators will determine if the aortic and carotid intimal-medial thickness are related the relationship of cardiovascular risk factors to aortic intimal-medial thickness and the progression of carotid intimal-medial thickness and the relationship of aortic and carotid intimal-medial thickness in the offspring to subclinical or clinical disease in their parents

Study Oversight

Has Oversight DMC: None
Is a FDA Regulated Drug?: None
Is a FDA Regulated Device?: None
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: None
Secondary IDs
Secondary ID Type Domain Link
R01HL054730 NIH None httpsreporternihgovquickSearchR01HL054730