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Early Detection of Arteriosclerosis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00863967
Recruitment Status : Unknown
Verified March 2009 by Kantonsspital Baselland Bruderholz.
Recruitment status was:  Active, not recruiting
First Posted : March 18, 2009
Last Update Posted : March 18, 2009
Sponsor:
Information provided by:
Kantonsspital Baselland Bruderholz

Tracking Information
First Submitted Date March 17, 2009
First Posted Date March 18, 2009
Last Update Posted Date March 18, 2009
Study Start Date October 2003
Estimated Primary Completion Date October 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: March 17, 2009)
Cardiovascular events [ Time Frame: 10 years at least ]
Original Primary Outcome Measures Same as current
Change History No Changes Posted
Current Secondary Outcome Measures
 (submitted: March 17, 2009)
Disease activity score [ Time Frame: 2 / 5 / 10 years ]
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Early Detection of Arteriosclerosis
Official Title Prospective Observational Cohort Study for Early Detection of Arteriosclerosis
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.

Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Retention:   Samples With DNA
Description:
Whole blood / serum / white cells / plasma
Sampling Method Probability Sample
Study Population teaching hospital primary care clinic
Condition
  • Arteriosclerosis
  • Atherosclerosis
  • Myocardial Infarction
  • Stroke
  • Diabetes Mellitus
  • Peripheral Arterial Occlusive Disease
Intervention Not Provided
Study Groups/Cohorts
  • 1
    no cardiovascular events
  • 2
    proven cardiovascular events
  • 3
    possible cardiovascular events
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Unknown status
Actual Enrollment
 (submitted: March 17, 2009)
269
Original Actual Enrollment Same as current
Estimated Study Completion Date October 2015
Estimated Primary Completion Date October 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • 18 years and older
  • informed consent

Exclusion Criteria:

  • life-threatening disease
  • life expectancy < 1 month
  • uncapable to provide informed consent
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number NCT00863967
Other Study ID Numbers KSBH: 216/03
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Barbara Biedermann MD, Department of medicine, Kantonsspital Bruderholz, CH-4101 Bruderholz
Study Sponsor Kantonsspital Baselland Bruderholz
Collaborators Not Provided
Investigators
Principal Investigator: Barbara Biedermann, MD Medical Department Kantonsspital Bruderholz CH-4101 Bruderholz
PRS Account Kantonsspital Baselland Bruderholz
Verification Date March 2009