Clinical trial NCT00005130: Coronary Artery Risk Development in Young Adults
Official title: Coronary Artery Risk Development in Young Adults (CARDIA)
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Cardiovascular Diseases
Coronary Disease
Hypertension
Heart Diseases
Obesity
Diabetes Mellitus
Lead sponsor: National Heart, Lung, and Blood Institute (NHLBI)
Sponsor class: NIH
First posted: 2000-05-26
Enrollment: 5115
Sex: ALL
Minimum age (years): 18
Maximum age (years): 30
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Black and White males and females 18 to 30 years of age at baseline.

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 lifestyles 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 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 over 35 years 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 67 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 June 2026 and will continue through July 2027. There will be an estimated 3,103 participants from four field centers that will participate in this exam.

Eligibility criteria: 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

Primary outcomes:
measure: Cardiovascular disease
timeFrame: baseline (1985) through 2033
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Medical University of South Carolina
name: Daniel T. Lackland
role: STUDY_CHAIR
affiliation: University of Alabama at Birmingham
name: James M. Shikany
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Alabama at Birmingham
name: Cora E. Lewis
role: PRINCIPAL_INVESTIGATOR
affiliation: Northwestern University
name: Donald Lloyd-Jones
role: PRINCIPAL_INVESTIGATOR
affiliation: Kaiser Foundation Research Institute
name: Ankeet S. Bhatt
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Minnesota
name: Pamela J. Schreiner
role: PRINCIPAL_INVESTIGATOR
References:
citation: For a bibliography see http://www.cardia.dopm.uab.edu/
citation: Hao QY, Gao JW, Yuan ZM, Gao M, Wang JF, Schiele F, Zhang SL, Liu PM. Remnant Cholesterol and the Risk of Coronary Artery Calcium Progression: Insights From the CARDIA and MESA Study. Circ Cardiovasc Imaging. 2022 Jul;15(7):e014116. doi: 10.1161/CIRCIMAGING.122.014116. Epub 2022 Jul 8.
citation: Heravi AS, Michos ED, Zhao D, Ambale-Venkatesh B, Doria De Vasconcellos H, Lloyd-Jones D, Schreiner PJ, Reis JP, Wu C, Lewis CE, Shikany JM, Sidney S, Guallar E, Ndumele CE, Ouyang P, Hoogeveen RC, Lima JAC, Vaidya D, Post WS. Oxidative Stress and Menopausal Status: The Coronary Artery Risk Development in Young Adults Cohort Study. J Womens Health (Larchmt). 2022 Jul;31(7):1057-1065. doi: 10.1089/jwh.2021.0248. Epub 2022 Jun 8.
citation: Gao JW, You S, Liu ZY, Hao QY, Wang JF, Vuitton DA, Zhang SL, Liu PM. Different Metabolic Phenotypes of Obesity and Risk of Coronary Artery Calcium Progression and Incident Cardiovascular Disease Events: The CARDIA Study. Arterioscler Thromb Vasc Biol. 2022 May;42(5):677-688. doi: 10.1161/ATVBAHA.122.317526. Epub 2022 Apr 7.
citation: Feng W, Zhang Z, Liu Y, Li Z, Guo W, Huang F, Zhang J, Chen A, Ou C, Zhang K, Chen M. Association of Chronic Respiratory Symptoms With Incident Cardiovascular Disease and All-Cause Mortality: Findings From the Coronary Artery Risk Development in Young Adults Study. Chest. 2022 Apr;161(4):1036-1045. doi: 10.1016/j.chest.2021.10.029. Epub 2021 Nov 2.
citation: Gao (高静伟) JW, Hao (郝卿鋆) QY, Zhang (张海峰) HF, Li (李雄志) XZ, Yuan (袁智敏) ZM, Guo (郭颖) Y, Wang (王景峰) JF, Zhang (张少玲) SL, Liu (刘品明) PM. Low-Carbohydrate Diet Score and Coronary Artery Calcium Progression: Results From the CARDIA Study. Arterioscler Thromb Vasc Biol. 2021 Jan;41(1):491-500. doi: 10.1161/ATVBAHA.120.314838. Epub 2020 Oct 29.
citation: Washko GR, Colangelo LA, Estepar RSJ, Ash SY, Bhatt SP, Okajima Y, Liu K, Jacobs DR Jr, Iribarren C, Thyagarajan B, Lewis CE, Kumar R, Han MK, Dransfield MT, Carnethon MR, Kalhan R. Adult Life-Course Trajectories of Lung Function and the Development of Emphysema: The CARDIA Lung Study. Am J Med. 2020 Feb;133(2):222-230.e11. doi: 10.1016/j.amjmed.2019.06.049. Epub 2019 Jul 29.
citation: Benck LR, Cuttica MJ, Colangelo LA, Sidney S, Dransfield MT, Mannino DM, Jacobs DR Jr, Lewis CE, Zhu N, Washko GR, Liu K, Carnethon MR, Kalhan R. Association between Cardiorespiratory Fitness and Lung Health from Young Adulthood to Middle Age. Am J Respir Crit Care Med. 2017 May 1;195(9):1236-1243. doi: 10.1164/rccm.201610-2089OC.
citation: Natarajan P, Young R, Stitziel NO, Padmanabhan S, Baber U, Mehran R, Sartori S, Fuster V, Reilly DF, Butterworth A, Rader DJ, Ford I, Sattar N, Kathiresan S. Polygenic Risk Score Identifies Subgroup With Higher Burden of Atherosclerosis and Greater Relative Benefit From Statin Therapy in the Primary Prevention Setting. Circulation. 2017 May 30;135(22):2091-2101. doi: 10.1161/CIRCULATIONAHA.116.024436. Epub 2017 Feb 21.
citation: Bantle AE, Chow LS, Steffen LM, Wang Q, Hughes J, Durant NH, Ingram KH, Reis JP, Schreiner PJ. Association of Mediterranean diet and cardiorespiratory fitness with the development of pre-diabetes and diabetes: the Coronary Artery Risk Development in Young Adults (CARDIA) study. BMJ Open Diabetes Res Care. 2016 Aug 31;4(1):e000229. doi: 10.1136/bmjdrc-2016-000229. eCollection 2016.
citation: Kirkegaard H, Nohr EA, Rasmussen KM, Stovring H, Sorensen TI, Lewis CE, Gunderson EP. Maternal prepregnancy waist circumference and BMI in relation to gestational weight gain and breastfeeding behavior: the CARDIA study. Am J Clin Nutr. 2015 Aug;102(2):393-401. doi: 10.3945/ajcn.114.099184. Epub 2015 Jul 1.
citation: Shikany JM, Jacobs DR Jr, Lewis CE, Steffen LM, Sternfeld B, Carnethon MR, Richman JS. Associations between food groups, dietary patterns, and cardiorespiratory fitness in the Coronary Artery Risk Development in Young Adults study. Am J Clin Nutr. 2013 Dec;98(6):1402-9. doi: 10.3945/ajcn.113.058826. Epub 2013 Oct 2.
citation: Ogunyankin KO, Liu K, Lloyd-Jones DM, Colangelo LA, Gardin JM. Reference values of right ventricular end-diastolic area defined by ethnicity and gender in a young adult population: the CARDIA study. Echocardiography. 2011 Feb;28(2):142-9. doi: 10.1111/j.1540-8175.2010.01290.x. Epub 2011 Jan 7.
citation: Kalhan R, Tran BT, Colangelo LA, Rosenberg SR, Liu K, Thyagarajan B, Jacobs DR Jr, Smith LJ. Systemic inflammation in young adults is associated with abnormal lung function in middle age. PLoS One. 2010 Jul 2;5(7):e11431. doi: 10.1371/journal.pone.0011431.
citation: Bibbins-Domingo K, Pletcher MJ, Lin F, Vittinghoff E, Gardin JM, Arynchyn A, Lewis CE, Williams OD, Hulley SB. Racial differences in incident heart failure among young adults. N Engl J Med. 2009 Mar 19;360(12):1179-90. doi: 10.1056/NEJMoa0807265.