NCT00005496

Brief Summary

To examine markers of underlying chronic inflammation and infection as potential risk factors for future myocardial infarction (MI), stroke (CVA), and venous thromboembolism (VTE) in plasma samples collected at baseline from healthy participants in the Physicians' Health Study (PHS).

Trial Health

100
On Track

Trial Health Score

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

Timeline
Completed

Started Sep 1998

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

September 1, 1998

Completed
1.7 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
2.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2002

Completed
Last Updated

March 16, 2016

Status Verified

February 1, 2005

First QC Date

May 25, 2000

Last Update Submit

March 15, 2016

Conditions

Eligibility Criteria

AgeUp to 100 Years
Sexmale
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older 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 (24)

  • Ridker PM, Rifai N, Stampfer MJ, Hennekens CH. Plasma concentration of interleukin-6 and the risk of future myocardial infarction among apparently healthy men. Circulation. 2000 Apr 18;101(15):1767-72. doi: 10.1161/01.cir.101.15.1767.

    PMID: 10769275BACKGROUND
  • Rifai N, Tracy RP, Ridker PM. Clinical efficacy of an automated high-sensitivity C-reactive protein assay. Clin Chem. 1999 Dec;45(12):2136-41.

    PMID: 10585345BACKGROUND
  • Ridker PM, Hennekens CH, Stampfer MJ, Wang F. Prospective study of herpes simplex virus, cytomegalovirus, and the risk of future myocardial infarction and stroke. Circulation. 1998 Dec 22-29;98(25):2796-9. doi: 10.1161/01.cir.98.25.2796.

    PMID: 9860778BACKGROUND
  • Blake GJ, Ridker PM. High sensitivity C-reactive protein for predicting cardiovascular disease: an inflammatory hypothesis. Eur Heart J. 2001 Mar;22(5):349-52. doi: 10.1053/euhj.2000.2280. No abstract available.

    PMID: 11207073BACKGROUND
  • Zee RY, Bates D, Ridker PM. A prospective evaluation of the CD14 and CD18 gene polymorphisms and risk of stroke. Stroke. 2002 Apr;33(4):892-5. doi: 10.1161/01.str.0000014564.75483.ec.

    PMID: 11935032BACKGROUND
  • Liu S, Manson JE, Buring JE, Stampfer MJ, Willett WC, Ridker PM. Relation between a diet with a high glycemic load and plasma concentrations of high-sensitivity C-reactive protein in middle-aged women. Am J Clin Nutr. 2002 Mar;75(3):492-8. doi: 10.1093/ajcn/75.3.492.

    PMID: 11864854BACKGROUND
  • Zee RY, Lunze K, Lindpaintner K, Ridker PM. A prospective evaluation of the interleukin-1 receptor antagonist intron 2 gene polymorphism and the risk of myocardial infarction. Thromb Haemost. 2001 Nov;86(5):1141-3.

    PMID: 11816697BACKGROUND
  • Albert MA, Rifai N, Ridker PM. Plasma levels of cystatin-C and mannose binding protein are not associated with risk of developing systemic atherosclerosis. Vasc Med. 2001;6(3):145-9. doi: 10.1177/1358836x0100600304.

    PMID: 11789968BACKGROUND
  • Blake GJ, Schmitz C, Lindpaintner K, Ridker PM. Mutation in the promoter region of the beta-fibrinogen gene and the risk of future myocardial infarction, stroke and venous thrombosis. Eur Heart J. 2001 Dec;22(24):2262-6. doi: 10.1053/euhj.2001.2692.

    PMID: 11728146BACKGROUND
  • Blake GJ, Dada N, Fox JC, Manson JE, Ridker PM. A prospective evaluation of lipoprotein-associated phospholipase A(2) levels and the risk of future cardiovascular events in women. J Am Coll Cardiol. 2001 Nov 1;38(5):1302-6. doi: 10.1016/s0735-1097(01)01554-6.

    PMID: 11691499BACKGROUND
  • Chae CU, Lee RT, Rifai N, Ridker PM. Blood pressure and inflammation in apparently healthy men. Hypertension. 2001 Sep;38(3):399-403. doi: 10.1161/01.hyp.38.3.399.

    PMID: 11566912BACKGROUND
  • Ridker PM, Danesh J, Youngman L, Collins R, Stampfer MJ, Peto R, Hennekens CH. A prospective study of Helicobacter pylori seropositivity and the risk for future myocardial infarction among socioeconomically similar U.S. men. Ann Intern Med. 2001 Aug 7;135(3):184-8. doi: 10.7326/0003-4819-135-3-200108070-00010.

    PMID: 11487485BACKGROUND
  • Pradhan AD, Manson JE, Rifai N, Buring JE, Ridker PM. C-reactive protein, interleukin 6, and risk of developing type 2 diabetes mellitus. JAMA. 2001 Jul 18;286(3):327-34. doi: 10.1001/jama.286.3.327.

    PMID: 11466099BACKGROUND
  • Ridker PM, Rifai N, Clearfield M, Downs JR, Weis SE, Miles JS, Gotto AM Jr; Air Force/Texas Coronary Atherosclerosis Prevention Study Investigators. Measurement of C-reactive protein for the targeting of statin therapy in the primary prevention of acute coronary events. N Engl J Med. 2001 Jun 28;344(26):1959-65. doi: 10.1056/NEJM200106283442601.

    PMID: 11430324BACKGROUND
  • Zee RY, Lindpaintner K, Struk B, Hennekens CH, Ridker PM. A prospective evaluation of the CD14 C(-260)T gene polymorphism and the risk of myocardial infarction. Atherosclerosis. 2001 Feb 15;154(3):699-702. doi: 10.1016/s0021-9150(00)00698-5.

    PMID: 11257272BACKGROUND
  • Redberg RF, Rifai N, Gee L, Ridker PM. Lack of association of C-reactive protein and coronary calcium by electron beam computed tomography in postmenopausal women: implications for coronary artery disease screening. J Am Coll Cardiol. 2000 Jul;36(1):39-43. doi: 10.1016/s0735-1097(00)00680-x.

    PMID: 10898410BACKGROUND
  • Ridker PM, Hennekens CH, Buring JE, Rifai N. C-reactive protein and other markers of inflammation in the prediction of cardiovascular disease in women. N Engl J Med. 2000 Mar 23;342(12):836-43. doi: 10.1056/NEJM200003233421202.

    PMID: 10733371BACKGROUND
  • Ridker PM, Hennekens CH, Buring JE, Kundsin R, Shih J. Baseline IgG antibody titers to Chlamydia pneumoniae, Helicobacter pylori, herpes simplex virus, and cytomegalovirus and the risk for cardiovascular disease in women. Ann Intern Med. 1999 Oct 19;131(8):573-7. doi: 10.7326/0003-4819-131-8-199910190-00004.

    PMID: 10523217BACKGROUND
  • Ridker PM, Hennekens CH, Rifai N, Buring JE, Manson JE. Hormone replacement therapy and increased plasma concentration of C-reactive protein. Circulation. 1999 Aug 17;100(7):713-6. doi: 10.1161/01.cir.100.7.713.

    PMID: 10449692BACKGROUND
  • Blake GJ, Otvos JD, Rifai N, Ridker PM. Low-density lipoprotein particle concentration and size as determined by nuclear magnetic resonance spectroscopy as predictors of cardiovascular disease in women. Circulation. 2002 Oct 8;106(15):1930-7. doi: 10.1161/01.cir.0000033222.75187.b9.

    PMID: 12370215BACKGROUND
  • Pradhan AD, Rifai N, Ridker PM. Soluble intercellular adhesion molecule-1, soluble vascular adhesion molecule-1, and the development of symptomatic peripheral arterial disease in men. Circulation. 2002 Aug 13;106(7):820-5. doi: 10.1161/01.cir.0000025636.03561.ee.

    PMID: 12176954BACKGROUND
  • Zee RY, Bates D, Ridker PM. A prospective evaluation of the heat shock protein 70 gene polymorphisms and the risk of stroke. Thromb Haemost. 2002 Apr;87(4):622-5.

    PMID: 12008944BACKGROUND
  • Zee RY, Ridker PM. Polymorphism in the human C-reactive protein (CRP) gene, plasma concentrations of CRP, and the risk of future arterial thrombosis. Atherosclerosis. 2002 May;162(1):217-9. doi: 10.1016/s0021-9150(01)00703-1.

    PMID: 11947917BACKGROUND
  • Zee RY, Hegener HH, Cook NR, Ridker PM. C-reactive protein gene polymorphisms and the risk of venous thromboembolism: a haplotype-based analysis. J Thromb Haemost. 2004 Aug;2(8):1240-3. doi: 10.1111/j.1538-7836.2004.00773.x.

    PMID: 15304023BACKGROUND

MeSH Terms

Conditions

Cardiovascular DiseasesCoronary DiseaseStrokeMyocardial InfarctionVenous ThromboembolismHeart DiseasesInfectionsChlamydia InfectionsCytomegalovirus InfectionsHelicobacter InfectionsHerpesviridae InfectionsInflammation

Condition Hierarchy (Ancestors)

Myocardial IschemiaVascular DiseasesCerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesInfarctionIschemiaPathologic ProcessesPathological Conditions, Signs and SymptomsNecrosisThromboembolismEmbolism and ThrombosisChlamydiaceae InfectionsGram-Negative Bacterial InfectionsBacterial InfectionsBacterial Infections and MycosesSexually Transmitted Diseases, BacterialSexually Transmitted DiseasesCommunicable DiseasesGenital DiseasesUrogenital DiseasesDNA Virus InfectionsVirus Diseases

Study Officials

  • Paul Ridker

    Brigham and Women's Hospital

Study Design

Study Type
observational
Sponsor Type
NIH

Study Record Dates

First Submitted

May 25, 2000

First Posted

May 26, 2000

Study Start

September 1, 1998

Study Completion

August 1, 2002

Last Updated

March 16, 2016

Record last verified: 2005-02