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Coronary Artery Risk Development in Young Adults (CARDIA)

This study is ongoing, but not recruiting participants.
Information provided by National Heart, Lung, and Blood Institute (NHLBI)

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Descriptive Information Fields
Brief Title  Coronary Artery Risk Development in Young Adults (CARDIA)
Official Title 
Brief Summary

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.

Detailed Description

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 began 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.

Study Phase
Study Type  Observational
Study Design  Natural History, Longitudinal
Primary Outcome Measure 
Secondary Outcome Measure 
Condition  Cardiovascular Diseases
Coronary Disease
Hypertension
Heart Diseases
Obesity
Diabetes Mellitus
Intervention 
MEDLINE PMIDs
Links Related Info This link exits the ClinicalTrials.gov site
Recruitment Information Fields
Recruitment Status  Active, not recruiting
Enrollment 
Start Date  January 1984
Completion Date September 2008
Eligibility Criteria 

No eligibility criteria

Gender Male
Ages
Accepts Healthy Volunteers No
Contacts ††
Location Countries 
Administrative Information Fields
NCT ID  NCT00005130
Organization ID 1000
Secondary IDs ††
Study Sponsor  National Heart, Lung, and Blood Institute (NHLBI)
Collaborators ††
Investigators 
Investigator:     Jeffrey Carr     Wake Forest University    
Investigator:     Robert Detrano     Harbor-UCLA Research and Development Institute    
Investigator:     Cora Lewis     University of Alabama at Birmingham    
Investigator:     Kiang Liu     Northwestern University    
Investigator:     Daniel O'Leary     Tufts Medical Center    
Investigator:     Pamela Schreiner     University of Minnesota    
Investigator:     Stephen Sidney     Kaiser Foundation Research Institute    
Investigator:     O. Williams     University of Alabama at Birmingham    
Investigator:     Nathan Wong     University of California at Irvine    
Information Provided By National Heart, Lung, and Blood Institute (NHLBI)
Verification Date August 2005
First Received Date  May 25, 2000
Last Updated Date August 8, 2005

 †    Required WHO trial registration data element.
††   WHO trial registration data element that is required only if it exists.




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