NCT00863967

Brief Summary

Arteriosclerosis is a common chronic disease with well known risk factors like diabetes mellitus, hypertension, dyslipidemia, adipositas and smoking, leading to severe complications like myocardial infarction, stroke or peripheral arterial occlusive disease. In addition to life-style factors there is also a genetic predisposition to develop complicated atherosclerosis. Objective: Improve individual risk prediction by clinical phenotyping and genotyping.

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
269

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Oct 2003

Longer than P75 for all trials

Status
unknown

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

October 1, 2003

Completed
5.5 years until next milestone

First Submitted

Initial submission to the registry

March 17, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

March 18, 2009

Completed
6.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2015

Completed
Last Updated

March 18, 2009

Status Verified

March 1, 2009

Enrollment Period

12 years

First QC Date

March 17, 2009

Last Update Submit

March 17, 2009

Conditions

ArteriosclerosisAtherosclerosisMyocardial InfarctionStrokeDiabetes MellitusPeripheral Arterial Occlusive Disease

Keywords

physical examinationdiagnostic techniques and proceduresdiagnosisimmunologic testsdiagnostic testscausalitygenetic testbiomarker

Outcome Measures

Primary Outcomes (1)

  • Cardiovascular events

    10 years at least

Secondary Outcomes (1)

  • Disease activity score

    2 / 5 / 10 years

Study Arms (3)

1

no cardiovascular events

2

proven cardiovascular events

3

possible cardiovascular events

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

teaching hospital primary care clinic

You may qualify if:

  • years and older
  • informed consent

You may not qualify if:

  • life-threatening disease
  • life expectancy \< 1 month
  • uncapable to provide informed consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (9)

  • Biedermann BC, Sahner S, Gregor M, Tsakiris DA, Jeanneret C, Pober JS, Gratwohl A. Endothelial injury mediated by cytotoxic T lymphocytes and loss of microvessels in chronic graft versus host disease. Lancet. 2002 Jun 15;359(9323):2078-83. doi: 10.1016/S0140-6736(02)08907-9.

    PMID: 12086762BACKGROUND

  • Binder CJ, Chang MK, Shaw PX, Miller YI, Hartvigsen K, Dewan A, Witztum JL. Innate and acquired immunity in atherogenesis. Nat Med. 2002 Nov;8(11):1218-26. doi: 10.1038/nm1102-1218. No abstract available.

    PMID: 12411948BACKGROUND

  • Kiechl S, Lorenz E, Reindl M, Wiedermann CJ, Oberhollenzer F, Bonora E, Willeit J, Schwartz DA. Toll-like receptor 4 polymorphisms and atherogenesis. N Engl J Med. 2002 Jul 18;347(3):185-92. doi: 10.1056/NEJMoa012673.

    PMID: 12124407BACKGROUND

  • Nabel EG. Cardiovascular disease. N Engl J Med. 2003 Jul 3;349(1):60-72. doi: 10.1056/NEJMra035098. No abstract available.

    PMID: 12840094BACKGROUND

  • Nakajima T, Schulte S, Warrington KJ, Kopecky SL, Frye RL, Goronzy JJ, Weyand CM. T-cell-mediated lysis of endothelial cells in acute coronary syndromes. Circulation. 2002 Feb 5;105(5):570-5. doi: 10.1161/hc0502.103348.

    PMID: 11827921BACKGROUND

  • Ross R. Atherosclerosis--an inflammatory disease. N Engl J Med. 1999 Jan 14;340(2):115-26. doi: 10.1056/NEJM199901143400207. No abstract available.

    PMID: 9887164BACKGROUND

  • Stemme S, Faber B, Holm J, Wiklund O, Witztum JL, Hansson GK. T lymphocytes from human atherosclerotic plaques recognize oxidized low density lipoprotein. Proc Natl Acad Sci U S A. 1995 Apr 25;92(9):3893-7. doi: 10.1073/pnas.92.9.3893.

    PMID: 7732003BACKGROUND

  • Strong JP, Malcom GT, McMahan CA, Tracy RE, Newman WP 3rd, Herderick EE, Cornhill JF. Prevalence and extent of atherosclerosis in adolescents and young adults: implications for prevention from the Pathobiological Determinants of Atherosclerosis in Youth Study. JAMA. 1999 Feb 24;281(8):727-35. doi: 10.1001/jama.281.8.727.

    PMID: 10052443BACKGROUND

  • Yamada Y, Izawa H, Ichihara S, Takatsu F, Ishihara H, Hirayama H, Sone T, Tanaka M, Yokota M. Prediction of the risk of myocardial infarction from polymorphisms in candidate genes. N Engl J Med. 2002 Dec 12;347(24):1916-23. doi: 10.1056/NEJMoa021445.

    PMID: 12477941BACKGROUND

Biospecimen

Retention: SAMPLES WITH DNA

Whole blood / serum / white cells / plasma

MeSH Terms

Conditions

ArteriosclerosisAtherosclerosisMyocardial InfarctionStrokeDiabetes MellitusPeripheral Arterial Occlusive Disease 1Disease

Condition Hierarchy (Ancestors)

Arterial Occlusive DiseasesVascular DiseasesCardiovascular DiseasesMyocardial IschemiaHeart DiseasesInfarctionIschemiaPathologic ProcessesPathological Conditions, Signs and SymptomsNecrosisCerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Study Officials

  • Barbara Biedermann, MD

    Medical Department Kantonsspital Bruderholz CH-4101 Bruderholz

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER

Study Record Dates

First Submitted

March 17, 2009

First Posted

March 18, 2009

Study Start

October 1, 2003

Primary Completion

October 1, 2015

Study Completion

October 1, 2015

Last Updated

March 18, 2009

Record last verified: 2009-03