Early Detection of Arteriosclerosis - Full Text View

Sponsor:	Kantonsspital Bruderholz
Information provided by:	Kantonsspital Bruderholz
ClinicalTrials.gov Identifier:	NCT00863967

Purpose

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.

Condition
Arteriosclerosis Atherosclerosis Myocardial Infarction Stroke Diabetes Mellitus Peripheral Arterial Occlusive Disease

Study Type:	Observational
Study Design:	Observational Model: Cohort Time Perspective: Prospective
Official Title:	Prospective Observational Cohort Study for Early Detection of Arteriosclerosis

Resource links provided by NLM:

Genetics Home Reference related topics: 6q24-related transient neonatal diabetes mellitus

MedlinePlus related topics: Atherosclerosis Heart Attack High Blood Pressure

U.S. FDA Resources

Further study details as provided by Kantonsspital Bruderholz:

Primary Outcome Measures:

Cardiovascular events [ Time Frame: 10 years at least ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Disease activity score [ Time Frame: 2 / 5 / 10 years ] [ Designated as safety issue: No ]

Biospecimen Retention: Samples With DNA

Whole blood / serum / white cells / plasma

Enrollment:	269
Study Start Date:	October 2003
Estimated Study Completion Date:	October 2015
Estimated Primary Completion Date:	October 2015 (Final data collection date for primary outcome measure)

Groups/Cohorts
1 no cardiovascular events
2 proven cardiovascular events
3 possible cardiovascular events

Detailed Description:

About 300 patients who are treated for various conditions at the department of general medicine at our hospital will be included prospectively in the study. This observational cohort will be followed for at least 10 years follow-up examinations.

At baseline and during follow up visits detailed clinical phenotyping is planned (medical and family history,standardized clinical and physical examinations, lab, RX, ECG, stress-test or echocardiogram). The genotyping is performed by DNA-isolation from leucocytes collected at baseline.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No
Sampling Method:	Probability Sample

Study Population

teaching hospital primary care clinic

Criteria

Inclusion Criteria:

18 years and older
informed consent

Exclusion Criteria:

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00863967

Sponsors and Collaborators

Kantonsspital Bruderholz

Investigators

Principal Investigator:

Barbara Biedermann, MD

Medical Department Kantonsspital Bruderholz CH-4101 Bruderholz

More Information

Publications:

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.

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. Review. No abstract available.

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.

Nabel EG. Cardiovascular disease. N Engl J Med. 2003 Jul 3;349(1):60-72. Review. No abstract available. Erratum in: N Engl J Med. 2003 Aug 7;349(6):620.

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.

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

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.

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.

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.

Responsible Party:	Barbara Biedermann MD, Department of medicine, Kantonsspital Bruderholz, CH-4101 Bruderholz
ClinicalTrials.gov Identifier:	NCT00863967 History of Changes
Other Study ID Numbers:	KSBH: 216/03
Study First Received:	March 17, 2009
Last Updated:	March 17, 2009
Health Authority:	Switzerland: Ethikkommission

Keywords provided by Kantonsspital Bruderholz:

physical examination
diagnostic techniques and procedures
diagnosis
immunologic tests

diagnostic tests
causality
genetic test
biomarker

Additional relevant MeSH terms:

Arterial Occlusive Diseases
Arteriosclerosis
Atherosclerosis
Diabetes Mellitus
Infarction
Myocardial Infarction
Stroke
Peripheral Arterial Disease
Vascular Diseases
Cardiovascular Diseases
Glucose Metabolism Disorders
Metabolic Diseases

Endocrine System Diseases
Ischemia
Pathologic Processes
Necrosis
Myocardial Ischemia
Heart Diseases
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Peripheral Vascular Diseases

ClinicalTrials.gov processed this record on February 09, 2012