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Coronary Artery Risk Development in Young Adults (CARDIA)

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ClinicalTrials.gov Identifier: NCT00005130
Recruitment Status : Completed
First Posted : May 26, 2000
Last Update Posted : April 14, 2016
Sponsor:
Information provided by:
National Heart, Lung, and Blood Institute (NHLBI)

Tracking Information
First Submitted Date May 25, 2000
First Posted Date May 26, 2000
Last Update Posted Date April 14, 2016
Study Start Date January 1984
Actual Primary Completion Date September 2008   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures Not Provided
Original Primary Outcome Measures Not Provided
Change History Complete list of historical versions of study NCT00005130 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Outcome Measures Not Provided
Original Other Outcome Measures Not Provided
 
Descriptive Information
Brief Title Coronary Artery Risk Development in Young Adults (CARDIA)
Official Title Not Provided
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, which began recruitment in 1985, has completed 7 examinations over 20 years in a cohort of 5,115 men and women aged 18-30 years in four communities. Participants were initially sampled from the total population, selected census tracts or, in the case of one center, the membership of a large health plan. The original cohort had approximately equal representation by blacks and whites, men and women, those aged 18-24 and 25-30, and those with no more than a high school education and more than a high school education. The baseline examination (Year 0) was conducted over a 14-month period during 1985-86. The examination consisted of questionnaires on sociodemographic characteristics, health behaviors, and psychological factors; an exercise treadmill test; resting electrocardiography; a diet history assessment; anthropometry; pulmonary function testing; and resting blood pressure. Fasting blood measurements included total cholesterol and its subfractions, insulin, glucose, liver enzymes and other serum chemistry measurements, and hematology.

Six additional examinations have been completed every 2-5 years, including a Year 20 examination completed in 2006. Repeat measurements on traditional risk factors, including plasma lipids, blood pressure, anthropometry, smoking behavior, physical activity, and pulmonary function testing (except Years 7 and 15) have used the same methods at each examination to assess age and secular trends in these factors during young adulthood. In selected years, additional measurements have been made, including a treadmill exercise test at baseline and Year 7; diet history at baseline, Year 7, and Year 20; cardiovascular reactivity measurements in Year 2; echocardiography and ambulatory blood pressure monitoring (in a subset) at Year 5; skin reflectance and assessment of the experience of discrimination and other psychosocial measures and urine sodium and creatinine in Year 7; echocardiography (in a subset) in Year 10, glucose tolerance testing, and microalbuminuria in Year 10 and Year 20; coronary CT scan in Year 15 and Year 20; and carotid intima media thickness in Year 20.

Retention of the surviving cohort was 90, 86, 81, 79, 74, and 72 percent at each of the respective follow-up examinations. Cohort members are contacted every six month to obtain information on vital status and current residence. Every other six-month contact also includes speaking with the participant to ascertain information on current smoking status, major illness or injury, and hospitalizations.

The Year 25 examination began June, 2010 and will continue through May, 2011. There will be an estimated 3,525 participants from four field centers that will participate in the five hour examination. The study ends in 2013.

Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Black and white males and females 18 to 30 years of age at baseline.
Condition
  • Cardiovascular Diseases
  • Coronary Disease
  • Hypertension
  • Heart Diseases
  • Obesity
  • Diabetes Mellitus
Intervention Not Provided
Study Groups/Cohorts Not Provided
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Enrollment Not Provided
Original Enrollment Not Provided
Actual Study Completion Date September 2008
Actual Primary Completion Date September 2008   (Final data collection date for primary outcome measure)
Eligibility Criteria No eligibility criteria
Sex/Gender
Sexes Eligible for Study: All
Ages Child, Adult, Older Adult
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number NCT00005130
Other Study ID Numbers 1000
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Not Provided
Study Sponsor National Heart, Lung, and Blood Institute (NHLBI)
Collaborators Not Provided
Investigators
Principal Investigator: Jeffrey Carr Wake Forest University Health Sciences
Principal Investigator: Robert Detrano Harbor-UCLA Research and Development Institute
Principal Investigator: Cora Lewis University of Alabama at Birmingham
Principal Investigator: Kiang Liu Northwestern University
Principal Investigator: Daniel O'Leary Tufts Medical Center
Principal Investigator: Pamela Schreiner University of Minnesota - Clinical and Translational Science Institute
Principal Investigator: Stephen Sidney Kaiser Foundation Research Institute
Principal Investigator: O. Williams University of Alabama at Birmingham
Principal Investigator: Nathan Wong University of California at Irvine
PRS Account National Heart, Lung, and Blood Institute (NHLBI)
Verification Date April 2009