NCT00005692

Brief Summary

To determine inflammation markers over time in cardiovascular disease. To test the hypothesis that measures of coagulation and fibrinolysis correlate with the incidence of coronary heart disease (CHD) and other thrombosis related disorders, and to help identify those individuals at greatest risk, using the Cardiovascular Health Study (CHS) and Honolulu Heart Program (HHP) populations. These two genetically distinct populations had different event rates for CHD, and offered a unique opportunity to test associations that were uncovered by comparing results across populations.

Trial Health

100
On Track

Trial Health Score

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

Timeline
Completed

Started Apr 1992

Longer than P75 for all trials

Status
completed

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 Start

First participant enrolled

April 1, 1992

Completed
8.2 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
2.4 years until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2002

Completed
Last Updated

May 13, 2016

Status Verified

March 1, 2005

First QC Date

May 25, 2000

Last Update Submit

May 12, 2016

Conditions

Eligibility Criteria

Age65 Years - 100 Years
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)
No eligibility criteria

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

Sponsors & Collaborators

Related Publications (19)

  • Tracy RP, Lemaitre RN, Psaty BM, Ives DG, Evans RW, Cushman M, Meilahn EN, Kuller LH. Relationship of C-reactive protein to risk of cardiovascular disease in the elderly. Results from the Cardiovascular Health Study and the Rural Health Promotion Project. Arterioscler Thromb Vasc Biol. 1997 Jun;17(6):1121-7. doi: 10.1161/01.atv.17.6.1121.

    PMID: 9194763BACKGROUND
  • Macy EM, Hayes TE, Tracy RP. Variability in the measurement of C-reactive protein in healthy subjects: implications for reference intervals and epidemiological applications. Clin Chem. 1997 Jan;43(1):52-8.

    PMID: 8990222BACKGROUND
  • Calles-Escandon J, Ballor D, Harvey-Berino J, Ades P, Tracy R, Sobel B. Amelioration of the inhibition of fibrinolysis in elderly, obese subjects by moderate energy intake restriction. Am J Clin Nutr. 1996 Jul;64(1):7-11. doi: 10.1093/ajcn/64.1.7.

    PMID: 8669417BACKGROUND
  • Gubler DJ, Trent DW. Emergence of epidemic dengue/dengue hemorrhagic fever as a public health problem in the Americas. Infect Agents Dis. 1993 Dec;2(6):383-93.

    PMID: 8012739BACKGROUND
  • Cushman M, Meilahn EN, Psaty BM, Kuller LH, Dobs AS, Tracy RP. Hormone replacement therapy, inflammation, and hemostasis in elderly women. Arterioscler Thromb Vasc Biol. 1999 Apr;19(4):893-9. doi: 10.1161/01.atv.19.4.893.

    PMID: 10195915BACKGROUND
  • Cushman M, Lemaitre RN, Kuller LH, Psaty BM, Macy EM, Sharrett AR, Tracy RP. Fibrinolytic activation markers predict myocardial infarction in the elderly. The Cardiovascular Health Study. Arterioscler Thromb Vasc Biol. 1999 Mar;19(3):493-8. doi: 10.1161/01.atv.19.3.493.

    PMID: 10073948BACKGROUND
  • Sakkinen PA, Macy EM, Callas PW, Cornell ES, Hayes TE, Kuller LH, Tracy RP. Analytical and biologic variability in measures of hemostasis, fibrinolysis, and inflammation: assessment and implications for epidemiology. Am J Epidemiol. 1999 Feb 1;149(3):261-7. doi: 10.1093/oxfordjournals.aje.a009801.

    PMID: 9927222BACKGROUND
  • Smiles AM, Macy EM, Sakkinen PA, Bovill EG, Mann KG, Tracy RP. Variability in plasma prothrombin concentration: implications for use in epidemiology. Blood Coagul Fibrinolysis. 1998 Sep;9(6):525-31. doi: 10.1097/00001721-199809000-00010.

    PMID: 9819003BACKGROUND
  • Moyer MP, Tracy RP, Tracy PB, van't Veer C, Sparks CE, Mann KG. Plasma lipoproteins support prothrombinase and other procoagulant enzymatic complexes. Arterioscler Thromb Vasc Biol. 1998 Mar;18(3):458-65. doi: 10.1161/01.atv.18.3.458.

    PMID: 9514415BACKGROUND
  • Tracy RP. Inflammation markers and coronary heart disease. Curr Opin Lipidol. 1999 Oct;10(5):435-41. doi: 10.1097/00041433-199910000-00008.

    PMID: 10554706BACKGROUND
  • Geffken DF, Cushman M, Burke GL, Polak JF, Sakkinen PA, Tracy RP. Association between physical activity and markers of inflammation in a healthy elderly population. Am J Epidemiol. 2001 Feb 1;153(3):242-50. doi: 10.1093/aje/153.3.242.

    PMID: 11157411BACKGROUND
  • Lewis MR, Callas PW, Jenny NS, Tracy RP. Longitudinal stability of coagulation, fibrinolysis, and inflammation factors in stored plasma samples. Thromb Haemost. 2001 Dec;86(6):1495-500.

    PMID: 11776319BACKGROUND
  • Burke AP, Tracy RP, Kolodgie F, Malcom GT, Zieske A, Kutys R, Pestaner J, Smialek J, Virmani R. Elevated C-reactive protein values and atherosclerosis in sudden coronary death: association with different pathologies. Circulation. 2002 Apr 30;105(17):2019-23. doi: 10.1161/01.cir.0000015507.29953.38.

    PMID: 11980679BACKGROUND
  • Curb JD, Abbott RD, Rodriguez BL, Sakkinen P, Popper JS, Yano K, Tracy RP. C-reactive protein and the future risk of thromboembolic stroke in healthy men. Circulation. 2003 Apr 22;107(15):2016-20. doi: 10.1161/01.CIR.0000065228.20100.F7. Epub 2003 Apr 7.

    PMID: 12681999BACKGROUND
  • Jenny NS, Tracy RP, Ogg MS, Luong le A, Kuller LH, Arnold AM, Sharrett AR, Humphries SE. In the elderly, interleukin-6 plasma levels and the -174G>C polymorphism are associated with the development of cardiovascular disease. Arterioscler Thromb Vasc Biol. 2002 Dec 1;22(12):2066-71. doi: 10.1161/01.atv.0000040224.49362.60.

    PMID: 12482836BACKGROUND
  • Smiles AM, Jenny NS, Tang Z, Arnold A, Cushman M, Tracy RP. No association of plasma prothrombin concentration or the G20210A mutation with incident cardiovascular disease: results from the Cardiovascular Health Study. Thromb Haemost. 2002 Apr;87(4):614-21.

    PMID: 12008943BACKGROUND
  • Sakkinen P, Abbott RD, Curb JD, Rodriguez BL, Yano K, Tracy RP. C-reactive protein and myocardial infarction. J Clin Epidemiol. 2002 May;55(5):445-51. doi: 10.1016/s0895-4356(01)00502-9.

    PMID: 12007546BACKGROUND
  • Liu Y, Coresh J, Eustace JA, Longenecker JC, Jaar B, Fink NE, Tracy RP, Powe NR, Klag MJ. Association between cholesterol level and mortality in dialysis patients: role of inflammation and malnutrition. JAMA. 2004 Jan 28;291(4):451-9. doi: 10.1001/jama.291.4.451.

    PMID: 14747502BACKGROUND
  • Tracy RP. Thrombin, inflammation, and cardiovascular disease: an epidemiologic perspective. Chest. 2003 Sep;124(3 Suppl):49S-57S. doi: 10.1378/chest.124.3_suppl.49s.

    PMID: 12970124BACKGROUND

MeSH Terms

Conditions

Cardiovascular DiseasesCoronary DiseaseHeart DiseasesThrombosisInflammation

Condition Hierarchy (Ancestors)

Myocardial IschemiaVascular DiseasesEmbolism and ThrombosisPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Russell Tracy

    University of Vermont

Study Design

Study Type
observational
Sponsor Type
NIH

Study Record Dates

First Submitted

May 25, 2000

First Posted

May 26, 2000

Study Start

April 1, 1992

Study Completion

November 1, 2002

Last Updated

May 13, 2016

Record last verified: 2005-03