AtherosclerosisNCT00005131
Atherosclerosis Risk in Communities (ARIC)
An observational study of Atherosclerosis and Coronary Disease, run by National Heart, Lung, and Blood Institute (NHLBI).
Trial 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. Read more about this study
- Who is it for?
- Ages Up to 100 years
- Conditions the study is for
- Atherosclerosis, Coronary Disease, Coronary Heart Disease Risk Reduction
- How many people
- Not given
- Where
- No sites listed yet
- Study dates
- Jul 1985to Jan 2007
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 100 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
No eligibility criteria
About this study
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.
Read the 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.
- Conditions
- Atherosclerosis, Coronary Disease, Coronary Heart Disease Risk Reduction, Diabetes Mellitus, Cardiovascular Diseases, Heart Diseases
- Medical subject headings
- Atherosclerosis, Coronary Disease, Diabetes Mellitus, Cardiovascular Diseases, Heart Diseases, Heart Failure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 May 2000 (estimated)
- Study startJul 1985
- Primary completionJan 2007
- Study completionJan 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (24)Papers the sponsor has linked to this study.
- Other trials for AtherosclerosisStudies of the same condition, open and under way.
- More trials run by National Heart, Lung, and Blood Institute (NHLBI)The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
- Investigators
- Christie Ballantyne, Baylor College of MedicineLloyd Chambless, University of North CarolinaJosef Coresh, Johns Hopkins UniversityMatthew Davis, University of Wisconsin, MadisonAaron Folsom, University of MinnesotaGerardo Heiss, University of North CarolinaDaniel Jones, University of Mississippi Medical CenterKenneth Wu, Texas Health Science Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00005131
- Sponsor's protocol ID
- 1001
- Status last verified
- Apr 2009
- First submitted
- 25 May 2000
- Last updated
- 14 Apr 2016
- Results posted
- No
Publications
Please refer to the ARIC website for the complete bibliography: http://www.bios.unc.edu/cscc/ARIC/
Sen S, Marchesan JT, Moss K, Wood SM, Barton AE, Alonso A, Soliman EZ, Magnani JW, Johansen MC, Lakshminarayan K, Rosamond WD, Beck J. Dental Flossing May Lower the Risk for Incident Ischemic Stroke, Cardioembolic Stroke Subtype, and Atrial Fibrillation. Stroke. 2026 May;57(5):1273-1282. doi: 10.1161/STROKEAHA.125.054440. Epub 2026 Apr 8.
PubMed 41948826Huang M, Zhang S, Xu C, Li B, Lai Y, Zhan R, Guo Y, Ma Y, Liao X, Wu X, Zhuang X. Malnutrition increases the risk of atrial fibrillation. BMC Cardiovasc Disord. 2025 Sep 26;25(1):678. doi: 10.1186/s12872-025-05107-7.
PubMed 41013262Tong Y, Jia Y, Gong A, Li F, Zeng R. Systemic inflammation in midlife is associated with late-life functional limitations. Sci Rep. 2024 Jul 29;14(1):17434. doi: 10.1038/s41598-024-68724-w.
PubMed 39075139Li Y, Jia Y, Jiang W, Li D, Yu J, Liu Y, Liao X, Zhao Z. Association between cognitive impairment and risk of atrial fibrillation: The Atherosclerosis Risk in Communities study. Cardiol J. 2024;31(4):553-563. doi: 10.5603/cj.93107. Epub 2023 Oct 19.
PubMed 37853826Jia 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.
PubMed 35413794Zhuang 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.
PubMed 35157988Arora 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.
PubMed 34955335Li 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.
PubMed 34413768Li 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.
PubMed 34291073Li 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.
PubMed 34168437Gao 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.
PubMed 34167539Sun 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.
PubMed 32994225DeBarmore 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.
PubMed 32801120Fashanu 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.
PubMed 31640594
Study at a glance
From the registry record, last updated by the sponsor on 14 Apr 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Atherosclerosis Risk in Communities (ARIC)
- ClinicalTrials.gov ID
- NCT00005131
- Acronym / sponsor ID
- 1001
- Conditions
- Atherosclerosis, Coronary Disease, Coronary Heart Disease Risk Reduction, Diabetes Mellitus, Cardiovascular Diseases, Heart Diseases
- Study type
- Observational
- Recruitment status
- Completed
- Lead sponsor
- National Heart, Lung, and Blood Institute (NHLBI)US National Institutes of Health
- Study start
- Jul 1985
- Primary completion
- Jan 2007 (actual)
- Study completion
- Jan 2007 (actual)
- First posted
- 26 May 2000 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
Who may qualify
- Ages
- Up to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Apr 2016.
- BackgroundPlease refer to the ARIC website for the complete bibliography: http://www.bios.unc.edu/cscc/ARIC/
- Derived from this study: PubMed 41948826Sen S, Marchesan JT, Moss K, Wood SM, Barton AE, Alonso A, Soliman EZ, Magnani JW, Johansen MC, Lakshminarayan K, Rosamond WD, Beck J. Dental Flossing May Lower the Risk for Incident Ischemic Stroke, Cardioembolic Stroke Subtype, and Atrial Fibrillation. Stroke. 2026 May;57(5):1273-1282. doi: 10.1161/STROKEAHA.125.054440. Epub 2026 Apr 8.
- Derived from this study: PubMed 41013262Huang M, Zhang S, Xu C, Li B, Lai Y, Zhan R, Guo Y, Ma Y, Liao X, Wu X, Zhuang X. Malnutrition increases the risk of atrial fibrillation. BMC Cardiovasc Disord. 2025 Sep 26;25(1):678. doi: 10.1186/s12872-025-05107-7.
- Derived from this study: PubMed 39075139Tong Y, Jia Y, Gong A, Li F, Zeng R. Systemic inflammation in midlife is associated with late-life functional limitations. Sci Rep. 2024 Jul 29;14(1):17434. doi: 10.1038/s41598-024-68724-w.
- Derived from this study: PubMed 37853826Li Y, Jia Y, Jiang W, Li D, Yu J, Liu Y, Liao X, Zhao Z. Association between cognitive impairment and risk of atrial fibrillation: The Atherosclerosis Risk in Communities study. Cardiol J. 2024;31(4):553-563. doi: 10.5603/cj.93107. Epub 2023 Oct 19.
- Derived from this study: PubMed 35413794Jia 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.
- Derived from this study: PubMed 35157988Zhuang 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.
- Derived from this study: PubMed 34955335Arora 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.
- Derived from this study: PubMed 34413768Li 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.
- Derived from this study: PubMed 34291073Li 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.
- Derived from this study: PubMed 34168437Li 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.
- Derived from this study: PubMed 34167539Gao 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.
- Related InfoLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Christie Ballantyne
Baylor College of Medicine
Lloyd Chambless
University of North Carolina
Josef Coresh
Johns Hopkins University
Questions about this trial
What is this clinical trial studying?
An observational study of Atherosclerosis and Coronary Disease, run by National Heart, Lung, and Blood Institute (NHLBI).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Apr 2016. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00005131, which also lists 24 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Apr 2016.