Epidemiology of Carotid Artery Atherosclerosis in Youth

Cardiovascular Diseases Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00005397
• Other study ID #: 200501724
• Secondary ID: R01HL054730
• Status: Completed
• Phase: N/A
• First received: May 25, 2000
• Last updated: June 9, 2017
• Start date: September 1995
• Est. completion date: December 2008

Study information

• Verified date: June 2017
• Source: University of Iowa
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1360
• Est. completion date: December 2008
• Est. primary completion date: December 2008
• Accepts healthy volunteers: No
• Gender: All
• Age group: 11 Years to 50 Years

Eligibility

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

Related Conditions & MeSH terms

• Atherosclerosis
• Cardiovascular Diseases
• Carotid Artery Diseases
• Heart Diseases

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Patricia H Davis	National Heart, Lung, and Blood Institute (NHLBI)

References & Publications (4)

Davis PH, Dawson JD, Mahoney LT, Lauer RM. Increased carotid intimal-medial thickness and coronary calcification are related in young and middle-aged adults. The Muscatine study. Circulation. 1999 Aug 24;100(8):838-42. — View Citation

Davis PH, Dawson JD, Riley WA, Lauer RM. Carotid intimal-medial thickness is related to cardiovascular risk factors measured from childhood through middle age: The Muscatine Study. Circulation. 2001 Dec 4;104(23):2815-9. — View Citation

Dawson JD. Sample size calculations based on slopes and other summary statistics. Biometrics. 1998 Mar;54(1):323-30. — View Citation

Sonka M, Liang W, Lauer RM. Automated analysis of brachial ultrasound image sequences: early detection of cardiovascular disease via surrogates of endothelial function. IEEE Trans Med Imaging. 2002 Oct;21(10):1271-9. — View Citation