NCT00005133

Brief Summary

To determine the extent to which known risk factors predict coronary heart disease and stroke in the elderly, to assess the precipitants of coronary heart disease and stroke in the elderly, and to identify the predictors of mortality and functional impairments in clinical coronary disease or stroke.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
5,888

participants targeted

Target at P75+ for all trials

Timeline
21mo left

Started Jun 1988

Longer than P75 for all trials

Geographic Reach
1 country

6 active sites

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress96%
Jun 1988Dec 2027

Study Start

First participant enrolled

June 1, 1988

Completed
12 years until next milestone

First Submitted

Initial submission to the registry

May 25, 2000

Completed
1 day until next milestone

First Posted

Study publicly available on registry

May 26, 2000

Completed
27.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2027

Last Updated

February 3, 2026

Status Verified

January 1, 2026

Enrollment Period

39.6 years

First QC Date

May 25, 2000

Last Update Submit

January 30, 2026

Conditions

Eligibility Criteria

Age65 Years - 100 Years
Sexall
Healthy VolunteersYes
Age GroupsOlder Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Just over 5200 men and women (5201) were recruited from four communities: Forsyth County, North Carolina; Sacramento County, California; Washington County, Maryland; and Pittsburgh, Pennsylvania. An additional 687 African Americans were recruited after the initial baseline survey. The population from the Pittsburgh Field Center was entirely urban; and the other three Field Centers recruited a mixture of urban and rural populations.

Eligible participants were sampled from Medicare eligibility lists in each area. Those eligible included all persons living in the household of each individual sampled from the Health Care Financing Administration (HCFA) sampling frame, who were 65 years or older at the time of examination, were noninstitutionalized, were expected to remain in the area for the next three years, and were able to give informed consent and did not require a proxy respondent at baseline. Potentially eligible individuals who were wheelchair-bound in the home at baseline or were receiving hospice treatment, radiation therapy or chemotherapy for cancer were excluded.

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (6)

University of California, Davis

Sacramento, California, 95817, United States

Location

Johns Hopkins University

Hagerstown, Maryland, 21205, United States

Location

Wake Forest University School of Medicine

Winston-Salem, North Carolina, 27157, United States

Location

University of Pittsburgh

Pittsburgh, Pennsylvania, 15213, United States

Location

University of Vermont

Colchester, Vermont, 05446, United States

Location

University of Washington

Seattle, Washington, 98115, United States

Location

Related Publications (15)

  • Tang WHW, Lemaitre RN, Jensen PN, Wang M, Wang Z, Li XS, Nemet I, Lee Y, Lai HTM, de Oliveira Otto MC, Fretts AM, Sotoodehnia N, DiDonato JA, Backhed F, Psaty BM, Siscovick DS, Budoff MJ, Mozaffarian D, Hazen SL. Trimethylamine N-Oxide and Related Gut Microbe-Derived Metabolites and Incident Heart Failure Development in Community-Based Populations. Circ Heart Fail. 2024 Aug;17(8):e011569. doi: 10.1161/CIRCHEARTFAILURE.124.011569. Epub 2024 Aug 9.

  • Lemaitre RN, Jensen PN, Wang Z, Fretts AM, Sitlani CM, Nemet I, Sotoodehnia N, de Oliveira Otto MC, Zhu W, Budoff M, Longstreth WT, Psaty BM, Siscovick DS, Hazen SL, Mozaffarian D. Plasma Trimethylamine-N-Oxide and Incident Ischemic Stroke: The Cardiovascular Health Study and the Multi-Ethnic Study of Atherosclerosis. J Am Heart Assoc. 2023 Aug 15;12(16):e8711. doi: 10.1161/JAHA.122.029230. Epub 2023 Aug 10.

  • Carew AS, Mekary RA, Kirkland S, Theou O, Siddiqi F, Urquhart R, George M, Blanchard C, Biggs ML, Djousse L, Mukamal KJ, Cahill LE. Prospective study of breakfast frequency and timing and the risk of incident type 2 diabetes in community-dwelling older adults: the Cardiovascular Health Study. Am J Clin Nutr. 2022 Aug 4;116(2):325-334. doi: 10.1093/ajcn/nqac087.

  • Haslam DE, Peloso GM, Guirette M, Imamura F, Bartz TM, Pitsillides AN, Wang CA, Li-Gao R, Westra JM, Pitkanen N, Young KL, Graff M, Wood AC, Braun KVE, Luan J, Kahonen M, Kiefte-de Jong JC, Ghanbari M, Tintle N, Lemaitre RN, Mook-Kanamori DO, North K, Helminen M, Mossavar-Rahmani Y, Snetselaar L, Martin LW, Viikari JS, Oddy WH, Pennell CE, Rosendall FR, Ikram MA, Uitterlinden AG, Psaty BM, Mozaffarian D, Rotter JI, Taylor KD, Lehtimaki T, Raitakari OT, Livingston KA, Voortman T, Forouhi NG, Wareham NJ, de Mutsert R, Rich SS, Manson JE, Mora S, Ridker PM, Merino J, Meigs JB, Dashti HS, Chasman DI, Lichtenstein AH, Smith CE, Dupuis J, Herman MA, McKeown NM. Sugar-Sweetened Beverage Consumption May Modify Associations Between Genetic Variants in the CHREBP (Carbohydrate Responsive Element Binding Protein) Locus and HDL-C (High-Density Lipoprotein Cholesterol) and Triglyceride Concentrations. Circ Genom Precis Med. 2021 Aug;14(4):e003288. doi: 10.1161/CIRCGEN.120.003288. Epub 2021 Jul 16.

  • Lemaitre RN, Jensen PN, Hoofnagle A, McKnight B, Fretts AM, King IB, Siscovick DS, Psaty BM, Heckbert SR, Mozaffarian D, Sotoodehnia N. Plasma Ceramides and Sphingomyelins in Relation to Heart Failure Risk. Circ Heart Fail. 2019 Jul;12(7):e005708. doi: 10.1161/CIRCHEARTFAILURE.118.005708. Epub 2019 Jul 12.

  • 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.

  • Kuller LH, Lopez OL, Gottdiener JS, Kitzman DW, Becker JT, Chang Y, Newman AB. Subclinical Atherosclerosis, Cardiac and Kidney Function, Heart Failure, and Dementia in the Very Elderly. J Am Heart Assoc. 2017 Jul 22;6(7):e005353. doi: 10.1161/JAHA.116.005353.

  • Kuller LH, Lopez OL, Mackey RH, Rosano C, Edmundowicz D, Becker JT, Newman AB. Subclinical Cardiovascular Disease and Death, Dementia, and Coronary Heart Disease in Patients 80+ Years. J Am Coll Cardiol. 2016 Mar 8;67(9):1013-1022. doi: 10.1016/j.jacc.2015.12.034.

  • Lemaitre RN, Fretts AM, Sitlani CM, Biggs ML, Mukamal K, King IB, Song X, Djousse L, Siscovick DS, McKnight B, Sotoodehnia N, Kizer JR, Mozaffarian D. Plasma phospholipid very-long-chain saturated fatty acids and incident diabetes in older adults: the Cardiovascular Health Study. Am J Clin Nutr. 2015 May;101(5):1047-54. doi: 10.3945/ajcn.114.101857. Epub 2015 Mar 18.

  • Ma W, Wu JH, Wang Q, Lemaitre RN, Mukamal KJ, Djousse L, King IB, Song X, Biggs ML, Delaney JA, Kizer JR, Siscovick DS, Mozaffarian D. Prospective association of fatty acids in the de novo lipogenesis pathway with risk of type 2 diabetes: the Cardiovascular Health Study. Am J Clin Nutr. 2015 Jan;101(1):153-63. doi: 10.3945/ajcn.114.092601. Epub 2014 Nov 12.

  • Dashti HS, Follis JL, Smith CE, Tanaka T, Cade BE, Gottlieb DJ, Hruby A, Jacques PF, Lamon-Fava S, Richardson K, Saxena R, Scheer FA, Kovanen L, Bartz TM, Perala MM, Jonsson A, Frazier-Wood AC, Kalafati IP, Mikkila V, Partonen T, Lemaitre RN, Lahti J, Hernandez DG, Toft U, Johnson WC, Kanoni S, Raitakari OT, Perola M, Psaty BM, Ferrucci L, Grarup N, Highland HM, Rallidis L, Kahonen M, Havulinna AS, Siscovick DS, Raikkonen K, Jorgensen T, Rotter JI, Deloukas P, Viikari JS, Mozaffarian D, Linneberg A, Seppala I, Hansen T, Salomaa V, Gharib SA, Eriksson JG, Bandinelli S, Pedersen O, Rich SS, Dedoussis G, Lehtimaki T, Ordovas JM. Habitual sleep duration is associated with BMI and macronutrient intake and may be modified by CLOCK genetic variants. Am J Clin Nutr. 2015 Jan;101(1):135-43. doi: 10.3945/ajcn.114.095026. Epub 2014 Nov 26.

  • 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.

  • Banerjee D, Biggs ML, Mercer L, Mukamal K, Kaplan R, Barzilay J, Kuller L, Kizer JR, Djousse L, Tracy R, Zieman S, Lloyd-Jones D, Siscovick D, Carnethon M. Insulin resistance and risk of incident heart failure: Cardiovascular Health Study. Circ Heart Fail. 2013 May;6(3):364-70. doi: 10.1161/CIRCHEARTFAILURE.112.000022. Epub 2013 Apr 10.

  • Lemaitre RN, Sitlani C, Song X, King IB, McKnight B, Spiegelman D, Sacks FM, Djousse L, Rimm EB, Siscovick DS, Mozaffarian D. Circulating and dietary alpha-linolenic acid and incidence of congestive heart failure in older adults: the Cardiovascular Health Study. Am J Clin Nutr. 2012 Aug;96(2):269-74. doi: 10.3945/ajcn.112.037960. Epub 2012 Jun 27.

  • Barasch E, Gottdiener JS, Aurigemma G, Kitzman DW, Han J, Kop WJ, Tracy RP. The relationship between serum markers of collagen turnover and cardiovascular outcome in the elderly: the Cardiovascular Health Study. Circ Heart Fail. 2011 Nov;4(6):733-9. doi: 10.1161/CIRCHEARTFAILURE.111.962027. Epub 2011 Sep 7.

Related Links

Biospecimen

Retention: SAMPLES WITH DNA

Blood, Urine

MeSH Terms

Conditions

Cardiovascular DiseasesCoronary DiseaseHeart DiseasesStrokeDiabetes MellitusHypertensionHeart Failure

Condition Hierarchy (Ancestors)

Myocardial IschemiaVascular DiseasesCerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Study Officials

  • Mary F. Lyles, MD

    Bowman Gray School of Medicine

    PRINCIPAL INVESTIGATOR
  • Michelle Carlson, PhD

    Johns Hopkins University

    PRINCIPAL INVESTIGATOR
  • Bruce M. Psaty, MD PhD

    University of Washington

    PRINCIPAL INVESTIGATOR
  • Anne B. Newman, MD MPH

    University of Pittsburgh

    PRINCIPAL INVESTIGATOR
  • Calvin H. Hirsch, MD

    University of California, Davis

    PRINCIPAL INVESTIGATOR
  • Russell Tracy, PhD

    University of Vermont

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
NIH
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 25, 2000

First Posted

May 26, 2000

Study Start

June 1, 1988

Primary Completion (Estimated)

December 31, 2027

Study Completion (Estimated)

December 31, 2027

Last Updated

February 3, 2026

Record last verified: 2026-01

Locations