Early Detection of Arteriosclerosis

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by:
Kantonsspital Baselland Bruderholz
ClinicalTrials.gov Identifier:
NCT00863967
First received: March 17, 2009
Last updated: NA
Last verified: March 2009
History: No changes posted
  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:


Further study details as provided by Kantonsspital Baselland 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Sponsors and Collaborators
Kantonsspital Baselland Bruderholz
Investigators
Principal Investigator: Barbara Biedermann, MD Medical Department Kantonsspital Bruderholz CH-4101 Bruderholz
  More Information

Publications:

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 Baselland Bruderholz:
physical examination
diagnostic techniques and procedures
diagnosis
immunologic tests
diagnostic tests
causality
genetic test
biomarker

Additional relevant MeSH terms:
Atherosclerosis
Arteriosclerosis
Diabetes Mellitus
Infarction
Myocardial Infarction
Arterial Occlusive Diseases
Peripheral Arterial Disease
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Ischemia
Pathologic Processes
Necrosis
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases
Peripheral Vascular Diseases

ClinicalTrials.gov processed this record on September 30, 2014