Clinical trial NCT00863967: Early Detection of Arteriosclerosis
Official title: Prospective Observational Cohort Study for Early Detection of Arteriosclerosis
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Arteriosclerosis
Atherosclerosis
Myocardial Infarction
Stroke
Diabetes Mellitus
Peripheral Arterial Occlusive Disease
Keywords: physical examination
diagnostic techniques and procedures
diagnosis
immunologic tests
diagnostic tests
causality
genetic test
biomarker
Lead sponsor: Kantonsspital Baselland Bruderholz
Sponsor class: OTHER
First posted: 2009-03-18
Enrollment: 269
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: teaching hospital primary care clinic

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.

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 criteria: Inclusion Criteria:

* 18 years and older
* informed consent

Exclusion Criteria:

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

Primary outcomes:
measure: Cardiovascular events
timeFrame: 10 years at least
Secondary outcomes:
measure: Disease activity score
timeFrame: 2 / 5 / 10 years
Other outcomes:
Locations:
Study officials:
affiliation: Medical Department Kantonsspital Bruderholz CH-4101 Bruderholz
name: Barbara Biedermann, MD
role: PRINCIPAL_INVESTIGATOR
References:
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citation: 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.
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citation: Ross R. Atherosclerosis--an inflammatory disease. N Engl J Med. 1999 Jan 14;340(2):115-26. doi: 10.1056/NEJM199901143400207. No abstract available.
citation: 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.
citation: 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.
citation: 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.