To measure changes in coronary heart disease risk factors in cohorts of Black and white males and females 18 to 30 years of age at baseline. Also, to identify life styles during this age span which influence these changes in risk factors.

Condition
Cardiovascular Diseases Coronary Disease Hypertension Heart Diseases Obesity Diabetes Mellitus

Further Study Details: 

BACKGROUND: Both epidemiologic and clinical research in coronary heart disease have increased our awareness that some risk factors for disease such as obesity, hypertension, and hypercholesterolemia may be partially determined by genetic factors or habits which are formed in infancy, childhood, and adolescence. Studies to date also suggest that some of the coronary heart disease risk factors do not change dramatically before the late teenage years and that differences in characteristics by sex or race are most pronounced after this time. However, relatively little work has been done to identify the characteristics of young adult life which may be precursors to or coincident with the increase in risk factors prior to middle age. While major increases in certain risk factors occur in young adulthood in conjunction with significant changes in life style, the interrelationships among these risk factors and changes have not been rigorously investigated.

Cross-sectional data, for example, suggest that weight gain is pronounced during the late teens through age 30, particularly in males, and that a linear relationship exists between weight and lipoprotein fractions at these ages. The reasons for and consequences of this increase in adiposity need further investigation. The interaction of life events, behavior, and changes in physical activity and dietary intake that may influence weight gain and lipoprotein levels should be determined, as well as the importance of weight gain in relationship to risk factor changes during this age span.

Investigators have examined the consistency of blood pressure levels in children to determine whether "tracking" occurs into the teenage years. The results of these studies have raised other interesting and important questions. Is there evidence for "tracking" of other coronary risk factors? Does "tracking" persist into young adult life, a time during which dramatic changes in life style are often taking place? The study will contribute to our understanding of the development of atherosclerosis and will help to determine an optimal strategy for prevention before individual life style patterns become well established. The Working Group on Heart Disease Epidemiology in 1978 recommended the study with highest priority. The study was approved by the National Heart, Lung, and Blood Advisory Council in November 1982. The Request for Proposals was released in December 1982.

DESIGN NARRATIVE: CARDIA was funded initially in 1984 for a five year cycle that included two rounds of examinations. There were four clinical centers (Birmingham, AL; Chicago, IL; Minneapolis, MN; and Oakland, CA) and a Data Coordinating Center (Birmingham, AL). For initial examination, 5,115 black and white participants were recruited. Adequate numbers from the desired age, sex, race and educational groups were recruited so that the planned comparisons among subgroups could be made. Subsequent examinations were conducted during 1987-88, 1990-91, 1992-93, and 1995-6 with retention rates of 90, 86, 81, and 78 percent, respectively. Each examination has included the same core measurements, including blood pressure, lipids, anthropometric measurements, smoking, physical activity and assessments of sociodemographic and other psychosocial characteristics. New measurements have been included at each examination, including echocardiography in Years 5 and 10; detailed quantitative dietary assessments and maximal, symptom-limited treadmill testing at baseline and Year 7; 24 hour ambulatory blood pressure measurement; vascular distensibility; 72-hour urine collections for sodium, potassium, creatinine and magnesium; skin reflectance; selected psychological characteristics; vascular stiffness; and microalbuminuria. A pilot study of electron-beam computed tomography was conducted in Year 10 to assess coronary calcium.

Beginning in 2000, 78 percent of the surviving cohort underwent a 15 year re-examination of lifestyle and behavioral risk factors. Measurements for low density lipoprotein (LDL), folate, and pyridoxine were added to the 15 year exam which ended in September 2001. Candidate genes were examined and an immortalized cell line for genomic studies was created.

The Year 20 examination will begin in June, 2005 and continue through May 30, 2006. There will be an estimated 3,650 participants from four field centers in the six hour examination. The study ends in 2008.

Genders Eligible for Study:  Male

Criteria

No eligibility criteria

Study chairs or principal investigators

Jeffrey Carr,  Wake Forest University   
Robert Detrano,  Harbor-UCLA Research and Development Institute   
Cora Lewis,  University of Alabama   
Kiang Liu,  Northwestern University   
Daniel O'Leary,  New England Medical Center   
Pamela Schreiner,  University of Minnesota   
Stephen Sidney,  Kaiser Foundation Research Institute   
O. Williams,  University of Alabama   
Nathan Wong,  University of California at Irvine   

Study ID Numbers:  1000
Record last reviewed:  December 2004
Last Updated:  December 13, 2004
Record first received:  May 25, 2000
ClinicalTrials.gov Identifier:  NCT00005130
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-04-08