Early Detection of Arteriosclerosis

Stroke Clinical Trial

Official title:

Prospective Observational Cohort Study for Early Detection of Arteriosclerosis

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT00863967
• Other study ID #: KSBH: 216/03
• Status: Active, not recruiting
• Phase: N/A
• First received: March 17, 2009
• Last updated: March 17, 2009
• Start date: October 2003
• Est. completion date: October 2015

Study information

• Verified date: March 2009
• Source: Kantonsspital Baselland Bruderholz
• Contact: n/a
• Is FDA regulated: No
• Health authority: Switzerland: Ethikkommission
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 269
• Est. completion date: October 2015
• Est. primary completion date: October 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 18 years and older

• informed consent

Exclusion Criteria:

• life-threatening disease

• life expectancy < 1 month

• uncapable to provide informed consent

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Arterial Occlusive Diseases
• Arteriosclerosis
• Atherosclerosis
• Diabetes Mellitus
• Myocardial Infarction
• Peripheral Arterial Disease
• Peripheral Arterial Occlusive Disease
• Stroke

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Kantonsspital Baselland Bruderholz

References & 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. — View Citation

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. — View 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. — View Citation

Nabel EG. Cardiovascular disease. N Engl J Med. 2003 Jul 3;349(1):60-72. Review. Erratum in: N Engl J Med. 2003 Aug 7;349(6):620. — View Citation

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. — View Citation

Ross R. Atherosclerosis--an inflammatory disease. N Engl J Med. 1999 Jan 14;340(2):115-26. Review. — View 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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cardiovascular events		10 years at least	No
Secondary	Disease activity score		2 / 5 / 10 years	No