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Atherosclerosis Risk in Communities (ARIC)

Primary Purpose

Atherosclerosis, Coronary Disease, Coronary Heart Disease Risk Reduction

Status
Completed
Phase
Locations
Study Type
Observational
Intervention
Sponsored by
National Heart, Lung, and Blood Institute (NHLBI)
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an observational trial for Atherosclerosis

Eligibility Criteria

undefined - 100 Years (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

No eligibility criteria

Sites / Locations

    Outcomes

    Primary Outcome Measures

    Secondary Outcome Measures

    Full Information

    First Posted
    May 25, 2000
    Last Updated
    April 12, 2016
    Sponsor
    National Heart, Lung, and Blood Institute (NHLBI)
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00005131
    Brief Title
    Atherosclerosis Risk in Communities (ARIC)
    Study Type
    Observational

    2. Study Status

    Record Verification Date
    April 2009
    Overall Recruitment Status
    Completed
    Study Start Date
    July 1985 (undefined)
    Primary Completion Date
    January 2007 (Actual)
    Study Completion Date
    January 2007 (Actual)

    3. Sponsor/Collaborators

    Name of the Sponsor
    National Heart, Lung, and Blood Institute (NHLBI)

    4. Oversight

    5. Study Description

    Brief Summary
    To measure associations of established and suspected coronary heart disease risk factors with both atherosclerosis and new coronary heart disease events in representative cohorts from four diverse United States communities. To compare the communities with respect to risk factors, medical care, atherosclerosis, and coronary heart disease incidence. ARIC has two components in each community: study of representative cohorts of adult men and women, and community surveillance of morbidity and mortality.
    Detailed Description
    BACKGROUND: Although it is now firmly established that coronary heart disease mortality rates in the United States have fallen by about 50 percent since the mid 1960's, there has been no systematic program to study in parallel coronary heart disease morbidity and the prevalence of atherosclerosis. Such information is essential for an understanding of the factors influencing the time trends, for quantifying the effects of prevention versus treatment, and for guiding future policy in research and services. It remains a possibility that the mortality decline in past years was not accompanied by a reduction in incidence, or a diminution in the extent of the underlying arterial diseases. A trend confined to mortality would require different explanations and call for different strategies of prevention than a decline encompassing the whole spectrum of clinical manifestations, which would favor a risk factor explanation. ARIC surveillance provides cardiovascular incidence rates, and its cohorts provide information on atherosclerosis, cardiovascular symptoms, new and established risk factors and medical care utilization on representative residents of each community. New predictors of both atherosclerosis and cardiovascular diseases are investigated using data obtained at four examination centers, the ultrasound center and five central laboratories. The 1978 Conference on the Decline in Coronary Heart Disease Mortality and the 1979 Working Group on Heart Disease Epidemiology both recommended a community surveillance program. As a result, in 1980 the Clinical Applications and Prevention Advisory Committee and the National Heart, Lung, and Blood Advisory Council approved Phase I of the surveillance pilot study. Phase II of the pilot study and the full-scale study was approved by the Clinical Applications and Prevention Advisory Committee in May 1982. The Requests for Proposals for ARIC were released in September 1984 and awards made in 1985. DESIGN NARRATIVE: ARIC is a large-scale, long-term program that measures associations of established and suspected CHD risk factors with both atherosclerosis and new CHD events in men and women from four diverse communities. The project has two components: community surveillance of morbidity and mortality, and repeated examinations of a representative cohort of men and women in each community. The representative cohorts include 4,000 persons from each community. Three of these reflect the ethnic composition of the communities in which they live; one cohort is black. The community surveillance involves abstracting hospital records and death certificates and investigating out-of-hospital deaths for hospitalized myocardial infarction and CHD death in 800,000 men and women in these four communities. All cohort participants were examined four times (1987-90, and 1990-93, 1993-96, and 1996-99), and were contacted annually to update their medical histories. Atherosclerosis was measured by carotid ultrasonography. Arteriosclerosis was measured using retinal photography. Cerebrovascular disease was assessed using MRI in a sample of black and white participants. Risk factors studied include: blood lipids, lipoprotein cholesterols, and apolipoproteins; plasma hemostatic factors; blood chemistries and hematology and indicators of infectious and inflammatory disease; DNA markers of these risk factors, sitting, supine and standing blood pressures; anthropometry; fasting blood glucose and insulin levels; ECG findings; heart rate variability; cigarette and alcohol use; physical activity levels; dietary aspects; and family history. Novel factors are tested using nested case-control studies on stored blood. The fourth and final examination, which included a complete periodontal examination with measures of inflammatory markers was completed in 1999, with a return rate of 86%. Community surveillance currently provides complete age, race, and sex-specific rates of hospitalization for myocardial infarction and coronary heart disease death in the communities for 1987-1997. The study has been extended through January, 2007 to continue to follow the cohort through annual telephone calls and hospital surveillance to identify incident cardiovascular events through 19 years. Community surveillance continues to identify trends in cardiovascular disease incidence, case-fatality, and mortality in 35-74 year olds over a 19 year period. The diverse communities can be compared with respect to CHD incidence and medical care and, through the cohort component, with respect to risk factors and peripheral atherosclerosis. The results will provide a measure of the variation in the distribution and determinants of CHD in the U.S. and, within the limits of ecologic analysis, suggest possible reasons for observed differences.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Atherosclerosis, Coronary Disease, Coronary Heart Disease Risk Reduction, Diabetes Mellitus, Cardiovascular Diseases, Heart Diseases, Heart Failure, Congestive, Heart Failure

    7. Study Design

    10. Eligibility

    Sex
    All
    Maximum Age & Unit of Time
    100 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    No eligibility criteria
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Christie Ballantyne
    Organizational Affiliation
    Baylor College of Medicine
    First Name & Middle Initial & Last Name & Degree
    Lloyd Chambless
    Organizational Affiliation
    University of North Carolina
    First Name & Middle Initial & Last Name & Degree
    Josef Coresh
    Organizational Affiliation
    Johns Hopkins University
    First Name & Middle Initial & Last Name & Degree
    Matthew Davis
    Organizational Affiliation
    University of Wisconsin, Madison
    First Name & Middle Initial & Last Name & Degree
    Aaron Folsom
    Organizational Affiliation
    University of Minnesota
    First Name & Middle Initial & Last Name & Degree
    Gerardo Heiss
    Organizational Affiliation
    University of North Carolina
    First Name & Middle Initial & Last Name & Degree
    Daniel Jones
    Organizational Affiliation
    University of Mississippi Medical Center
    First Name & Middle Initial & Last Name & Degree
    Kenneth Wu
    Organizational Affiliation
    Texas Health Science Center

    12. IPD Sharing Statement

    Citations:
    Citation
    Please refer to the ARIC website for the complete bibliography: http://www.bios.unc.edu/cscc/ARIC/
    Results Reference
    background
    PubMed Identifier
    35413794
    Citation
    Jia Y, Li D, Yu J, Liu Y, Li F, Li W, Zhang Q, Gao Y, Zhang W, Zeng Z, Zeng R, Liao X, Zhao Q, Wan Z. Subclinical cardiovascular disease and frailty risk: the atherosclerosis risk in communities study. BMC Geriatr. 2022 Apr 12;22(1):321. doi: 10.1186/s12877-022-02974-z.
    Results Reference
    derived
    PubMed Identifier
    35157988
    Citation
    Zhuang XD, Tian T, Liao LZ, Dong YH, Zhou HJ, Zhang SZ, Chen WY, Du ZM, Wang XQ, Liao XX. Deep Phenotyping and Prediction of Long-term Cardiovascular Disease: Optimized by Machine Learning. Can J Cardiol. 2022 Jun;38(6):774-782. doi: 10.1016/j.cjca.2022.02.008. Epub 2022 Feb 11.
    Results Reference
    derived
    PubMed Identifier
    34955335
    Citation
    Arora S, Brown ZD, Sivaraj K, Hendrickson MJ, Mazzella AJ, Chang PP, Vaduganathan M, Qamar A, Gehi AK, Pandey A, Vavalle JP. The Relationship Between Atrial Fibrillation, Mitral Regurgitation, and Heart Failure Subtype: The ARIC Study. J Card Fail. 2022 Jun;28(6):883-892. doi: 10.1016/j.cardfail.2021.10.015. Epub 2021 Dec 23.
    Results Reference
    derived
    PubMed Identifier
    34413768
    Citation
    Li D, Jia Y, Yu J, Liu Y, Li F, Liu Y, Wu Q, Liao X, Zeng Z, Zeng R, Wan Z. Adherence to Healthy Lifestyle and the Risk of Function Limitations in Late Life: The Atherosclerosis Risk in Communities Study. Front Aging Neurosci. 2021 Aug 3;13:698699. doi: 10.3389/fnagi.2021.698699. eCollection 2021.
    Results Reference
    derived
    PubMed Identifier
    34291073
    Citation
    Li D, Jia Y, Yu J, Liu Y, Li F, Liu Y, Wu Q, Liao X, Zeng Z, Wan Z, Zeng R. Adherence to a Healthy Lifestyle and the Risk of All-Cause Mortality and Cardiovascular Events in Individuals With Diabetes: The ARIC Study. Front Nutr. 2021 Jul 5;8:698608. doi: 10.3389/fnut.2021.698608. eCollection 2021.
    Results Reference
    derived
    PubMed Identifier
    34168437
    Citation
    Li F, Li D, Yu J, Jia Y, Liu Y, Liu Y, Wu Q, Liao X, Zeng Z, Wan Z, Zeng R. Silent Myocardial Infarction and Long-Term Risk of Frailty: The Atherosclerosis Risk in Communities Study. Clin Interv Aging. 2021 Jun 18;16:1139-1149. doi: 10.2147/CIA.S315837. eCollection 2021.
    Results Reference
    derived
    PubMed Identifier
    34167539
    Citation
    Gao JW, Hao QY, Gao M, Zhang K, Li XZ, Wang JF, Vuitton DA, Zhang SL, Liu PM. Triglyceride-glucose index in the development of peripheral artery disease: findings from the Atherosclerosis Risk in Communities (ARIC) Study. Cardiovasc Diabetol. 2021 Jun 24;20(1):126. doi: 10.1186/s12933-021-01319-1.
    Results Reference
    derived
    PubMed Identifier
    32994225
    Citation
    Sun XT, Zeng C, Zhang SZ, Zhou HM, Zhong XB, Xiong ZY, Yang DY, Guo Y, Zhuang XD, Liao XX. Long-term tracking of fasting blood glucose variability and peripheral artery disease in people without diabetes. BMJ Open Diabetes Res Care. 2020 Sep;8(1):e000896. doi: 10.1136/bmjdrc-2019-000896.
    Results Reference
    derived
    PubMed Identifier
    32801120
    Citation
    DeBarmore B, Longchamps RJ, Zhang Y, Kalyani RR, Guallar E, Arking DE, Selvin E, Young JH. Mitochondrial DNA copy number and diabetes: the Atherosclerosis Risk in Communities (ARIC) study. BMJ Open Diabetes Res Care. 2020 Aug;8(1):e001204. doi: 10.1136/bmjdrc-2020-001204.
    Results Reference
    derived
    PubMed Identifier
    31640594
    Citation
    Fashanu OE, Zhao D, Schneider ALC, Rawlings AM, Sharrett AR, Lutsey PL, Gottesman RF, Gross AL, Guallar E, Alonso A, Mosley TH, Michos ED. Mid-life serum Vitamin D concentrations were associated with incident dementia but not late-life neuropsychological performance in the Atherosclerosis Risk in Communities (ARIC) Study. BMC Neurol. 2019 Oct 22;19(1):244. doi: 10.1186/s12883-019-1483-3.
    Results Reference
    derived
    PubMed Identifier
    29242352
    Citation
    Thorvaldsen T, Claggett BL, Shah A, Cheng S, Agarwal SK, Wruck LM, Chang PP, Rosamond WD, Lewis EF, Desai AS, Lund LH, Solomon SD. Predicting Risk in Patients Hospitalized for Acute Decompensated Heart Failure and Preserved Ejection Fraction: The Atherosclerosis Risk in Communities Study Heart Failure Community Surveillance. Circ Heart Fail. 2017 Dec;10(12):e003992. doi: 10.1161/CIRCHEARTFAILURE.117.003992.
    Results Reference
    derived
    PubMed Identifier
    29098321
    Citation
    McKeown NM, Dashti HS, Ma J, Haslam DE, Kiefte-de Jong JC, Smith CE, Tanaka T, Graff M, Lemaitre RN, Rybin D, Sonestedt E, Frazier-Wood AC, Mook-Kanamori DO, Li Y, Wang CA, Leermakers ETM, Mikkila V, Young KL, Mukamal KJ, Cupples LA, Schulz CA, Chen TA, Li-Gao R, Huang T, Oddy WH, Raitakari O, Rice K, Meigs JB, Ericson U, Steffen LM, Rosendaal FR, Hofman A, Kahonen M, Psaty BM, Brunkwall L, Uitterlinden AG, Viikari J, Siscovick DS, Seppala I, North KE, Mozaffarian D, Dupuis J, Orho-Melander M, Rich SS, de Mutsert R, Qi L, Pennell CE, Franco OH, Lehtimaki T, Herman MA. Sugar-sweetened beverage intake associations with fasting glucose and insulin concentrations are not modified by selected genetic variants in a ChREBP-FGF21 pathway: a meta-analysis. Diabetologia. 2018 Feb;61(2):317-330. doi: 10.1007/s00125-017-4475-0. Epub 2017 Nov 2.
    Results Reference
    derived
    PubMed Identifier
    28077376
    Citation
    Ogilvie RP, Lutsey PL, Heiss G, Folsom AR, Steffen LM. Dietary intake and peripheral arterial disease incidence in middle-aged adults: the Atherosclerosis Risk in Communities (ARIC) Study. Am J Clin Nutr. 2017 Mar;105(3):651-659. doi: 10.3945/ajcn.116.137497. Epub 2017 Jan 11.
    Results Reference
    derived
    PubMed Identifier
    28017350
    Citation
    Pokharel Y, Sun W, Virani SS, Nambi V, Hoogeveen RC, Chang PP, Ndumele CE, Solomon SD, Bozkurt B, Selvin E, Ballantyne CM, Deswal A. Myocardial Injury, Obesity, and the Obesity Paradox: The ARIC Study. JACC Heart Fail. 2017 Jan;5(1):56-63. doi: 10.1016/j.jchf.2016.10.010. Epub 2016 Dec 21.
    Results Reference
    derived
    PubMed Identifier
    23636237
    Citation
    Tanaka T, Ngwa JS, van Rooij FJ, Zillikens MC, Wojczynski MK, Frazier-Wood AC, Houston DK, Kanoni S, Lemaitre RN, Luan J, Mikkila V, Renstrom F, Sonestedt E, Zhao JH, Chu AY, Qi L, Chasman DI, de Oliveira Otto MC, Dhurandhar EJ, Feitosa MF, Johansson I, Khaw KT, Lohman KK, Manichaikul A, McKeown NM, Mozaffarian D, Singleton A, Stirrups K, Viikari J, Ye Z, Bandinelli S, Barroso I, Deloukas P, Forouhi NG, Hofman A, Liu Y, Lyytikainen LP, North KE, Dimitriou M, Hallmans G, Kahonen M, Langenberg C, Ordovas JM, Uitterlinden AG, Hu FB, Kalafati IP, Raitakari O, Franco OH, Johnson A, Emilsson V, Schrack JA, Semba RD, Siscovick DS, Arnett DK, Borecki IB, Franks PW, Kritchevsky SB, Lehtimaki T, Loos RJ, Orho-Melander M, Rotter JI, Wareham NJ, Witteman JC, Ferrucci L, Dedoussis G, Cupples LA, Nettleton JA. Genome-wide meta-analysis of observational studies shows common genetic variants associated with macronutrient intake. Am J Clin Nutr. 2013 Jun;97(6):1395-402. doi: 10.3945/ajcn.112.052183. Epub 2013 May 1.
    Results Reference
    derived
    PubMed Identifier
    22033999
    Citation
    Yang EY, Chambless L, Sharrett AR, Virani SS, Liu X, Tang Z, Boerwinkle E, Ballantyne CM, Nambi V. Carotid arterial wall characteristics are associated with incident ischemic stroke but not coronary heart disease in the Atherosclerosis Risk in Communities (ARIC) study. Stroke. 2012 Jan;43(1):103-8. doi: 10.1161/STROKEAHA.111.626200. Epub 2011 Oct 27.
    Results Reference
    derived
    PubMed Identifier
    21367942
    Citation
    Chatterjee R, Yeh HC, Shafi T, Anderson C, Pankow JS, Miller ER, Levine D, Selvin E, Brancati FL. Serum potassium and the racial disparity in diabetes risk: the Atherosclerosis Risk in Communities (ARIC) Study. Am J Clin Nutr. 2011 May;93(5):1087-91. doi: 10.3945/ajcn.110.007286. Epub 2011 Mar 2.
    Results Reference
    derived
    PubMed Identifier
    20082929
    Citation
    Yang EY, Nambi V, Tang Z, Virani SS, Boerwinkle E, Hoogeveen RC, Astor BC, Mosley TH, Coresh J, Chambless L, Ballantyne CM. Clinical implications of JUPITER (Justification for the Use of statins in Prevention: an Intervention Trial Evaluating Rosuvastatin) in a U.S. population insights from the ARIC (Atherosclerosis Risk in Communities) study. J Am Coll Cardiol. 2009 Dec 15;54(25):2388-95. doi: 10.1016/j.jacc.2009.10.006.
    Results Reference
    derived
    PubMed Identifier
    19153274
    Citation
    Myerson M, Coady S, Taylor H, Rosamond WD, Goff DC Jr; ARIC Investigators. Declining severity of myocardial infarction from 1987 to 2002: the Atherosclerosis Risk in Communities (ARIC) Study. Circulation. 2009 Feb 3;119(4):503-14. doi: 10.1161/CIRCULATIONAHA.107.693879. Epub 2009 Jan 19.
    Results Reference
    derived
    Available IPD and Supporting Information:
    Available IPD/Information Type
    Individual Participant Data Set
    Available IPD/Information URL
    http://biolincc.nhlbi.nih.gov/studies/aric/
    Available IPD/Information Identifier
    ARIC
    Available IPD/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.

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