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Epidemiology of Carotid Artery Atherosclerosis in Youth

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00005397
First Posted: May 26, 2000
Last Update Posted: June 12, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
National Heart, Lung, and Blood Institute (NHLBI)
Information provided by (Responsible Party):
Patricia H Davis, University of Iowa
  Purpose
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.

Condition
Atherosclerosis Cardiovascular Diseases Heart Diseases Carotid Artery Diseases

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective

Resource links provided by NLM:


Further study details as provided by Patricia H Davis, University of Iowa:

Biospecimen Retention:   Samples With DNA
Blood

Enrollment: 1360
Study Start Date: September 1995
Study Completion Date: December 2008
Primary Completion Date: December 2008 (Final data collection date for primary outcome measure)
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, Lp(a), 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.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   11 Years to 50 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
346 men and 379 women (members of original Muscatine cohort 635 members of the Muscatine Offspring cohort
Criteria

Representative of the original Muscatine childhood cohort with at least one measurement in childhood and one in young adulthood.

Members of the Muscatine Offspring Cohort

  Contacts and Locations
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): NCT00005397


Sponsors and Collaborators
Patricia H Davis
National Heart, Lung, and Blood Institute (NHLBI)
Investigators
Principal Investigator: Patricia H Davis, MD University of Iowa
  More Information