Clinical Trial on Heart Diseases, Cardiovascular Diseases, Coronary Disease, Hypertension, Obesity, Diabetes Mellitus - Clinical Trials Registry

Study Overview

Status

Active, not recruiting

Conditions

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 concentrations 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 10 examinations in a cohort of 5,115 men and women aged 18-30 years in four communities in the US. 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 Black and White individuals, men and women, those aged 18-24 and 25-30 years, 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.

Nine additional examinations have been completed every 2-5 years, including a Year 35 examination completed in 2022. 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, Year 7, Year 20, and Year 35 (in a subset); diet history at baseline, Year 7, Year 20, and Year 35 (in a subset); cardiovascular reactivity measurements in Year 2; echocardiography and ambulatory blood pressure monitoring at Year 5 (in a subset); 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; carotid intima media thickness in Year 20; and brain MRI (in a subset) in Years 25, 30, and 35.

Retention of the surviving cohort was 90, 86, 81, 79, 74, 72, 72, 71, and 71 percent at each of the respective follow-up examinations. Cohort members are contacted every six months 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 40 Exam will begin July 2026 and will continue through August 2027. There will be an estimated 2,994 participants from four field centers that will participate in this exam.

Study Type

Observational

Enrollment (Actual)

5115

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

Adult

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

Black and White males and females 18 to 30 years of age at baseline (1985-1986).

Description

Age 18-30 years, males and females, Black and White, free of long-term disease or disability that would interfere substantially with any part of the examination

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cardiovascular disease Time Frame: baseline (1985) through 2033	Incident coronary heart disease (fatal or nonfatal myocardial infarction, acute coronary syndrome without myocardial infarction, coronary revascularization, coronary heart disease death), stroke, heart failure, peripheral arterial disease	baseline (1985) through 2033

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National Heart, Lung, and Blood Institute (NHLBI)

Investigators

Principal Investigator: Mercedes R Carnethon, PhD, Northwestern University
Study Chair: Daniel T. Lackland, DrPH, Medical University of South Carolina
Principal Investigator: Jing Li, MD, DrPH, MS, University of Alabama at Birmingham
Principal Investigator: Cora E. Lewis, MD, MSPH, University of Alabama at Birmingham
Principal Investigator: Ankeet S. Bhatt, MD, MBA, ScM, Kaiser Foundation Research Institute
Principal Investigator: Weihong J. Tang, MD, PhD, University of Minnesota

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

CARDIA public website

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 1984

Primary Completion (Estimated)

June 30, 2033

Study Completion (Estimated)

June 30, 2033

Study Registration Dates

First Submitted

May 25, 2000

First Submitted That Met QC Criteria

May 25, 2000

First Posted (Estimated)

May 26, 2000

Study Record Updates

Last Update Posted (Actual)

February 2, 2026

Last Update Submitted That Met QC Criteria

January 29, 2026

Last Verified

January 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

1000

Plan for Individual participant data (IPD)

Study Data/Documents

Individual Participant Data Set
Information identifier: CARDIA

Information comments: NHLBI provides controlled access to IPD through BioLINCC. Access requires registration, evidence of local IRB approval or certification of exemption from IRB review, and completion of a data use agreement.
Study Protocol
Informed Consent Form
Data Collection Forms
Study Manuals

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Coronary Artery Risk Development in Young Adults (CARDIA)