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European Study of Cardiovascular Risk (EURIKA)

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: NCT00882336
Recruitment Status : Completed
First Posted : April 16, 2009
Last Update Posted : October 29, 2009
Sponsor:
Information provided by:
AstraZeneca

Tracking Information
First Submitted Date April 15, 2009
First Posted Date April 16, 2009
Last Update Posted Date October 29, 2009
Study Start Date May 2009
Primary Completion Date Not Provided
Current Primary Outcome Measures
 (submitted: April 15, 2009)
  • LDL-cholesterol, systolic and diastolic blood pressure, Tot. cholesterol, Non-HDL cholesterol, HDL-cholesterol, waist and hip circumference, HbA1c [ Time Frame: Cross-sectional ]
  • Gender, age, patients with diabetes and/or hypertension (%), smoker status, family medical history. [ Time Frame: Cross-sectional ]
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures
 (submitted: April 15, 2009)
  • BMI, Score based 10 year CHD mortality > 5%, High Risk patients (no. and %) [ Time Frame: Cross-sectional ]
  • Use of concomitant medication: anticoagulant, anti hypertensive, antidiabetic, lipid-lowering drugs [ Time Frame: Cross-sectional ]
  • Biomarkers: Apo-A1, Apo-B, Hs-CRP, Creatinine, albuminuria, uric acid, glomerular filtration rate. [ Time Frame: Cross-sectional ]
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 European Study of Cardiovascular Risk
Official Title Epidemiological Study of European Cardiovascular Risk Patients: Disease Prevention and Management in Usual Daily Practice
Brief Summary

The main objective of this study is to describe the management of patients with cardiovascular risk factors in primary prevention among different European countries.

The patient's participation consists of a single study visit during a routine visit of the patient to the clinic/office.

Study variables will be measured:

  • By an interview between physician and patient during the visit and/or available medical records' information: social and demographic patient characteristics, relevant family medical history, current medication.
  • By questions asked to the physician: physician perception of patients' CV risk factor, guidelines adherence and cost-containment.
  • By measurement performed to the patient during the visit: weight, height, BMI, waist and hip circumference will be measured.
  • CV risk factors (blood parameters) will be measured by collecting available data documented within the last year in the medical records and by the collection and analyses of a blood sample during the visit.
Detailed Description Not Provided
Study Type Observational
Study Design Time Perspective: Cross-Sectional
Target Follow-Up Duration Not Provided
Biospecimen Retention:   Samples Without DNA
Description:
Whole blood Serum
Sampling Method Probability Sample
Study Population Patients 50+ years old, with at least one additional CV risk factor (with no previous CV event or hospitalisation for a CV event) from Primary Care or hospital outpatient clinic.Participating investigators will belong either to PC centres or hospitals, in the proportion representing the reality on where this kind of patient is managed in each country.
Condition
  • Cardiovascular Risk Factors
  • Hyperlipidemia
  • Hypertension
  • Diabetes
  • Obesity
  • Smoking
Intervention Not Provided
Study Groups/Cohorts 1
Patients 50+ years old, with at least one additional CV risk factor (with no previous CV event or hospitalization for a CV event)
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 Completed
Estimated Enrollment
 (submitted: April 15, 2009)		 7200
Original Estimated Enrollment Same as current
Actual Study Completion Date October 2009
Primary Completion Date Not Provided
Eligibility Criteria

Inclusion Criteria:

  • Provision of informed consent.
  • Patients 50+ years old, with at least one additional CV risk factor (with no previous CV event or hospitalisation for a CV event) from Primary Care or hospital outpatient clinic.

Exclusion Criteria:

  • Subjects who are unwilling or unable to provide informed consent
  • Previous CV disease event or hospitalisation for a CV event
  • Current participation in a clinical trial
Sex/Gender
Sexes Eligible for Study: All
Ages 50 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 Austria,   Belgium,   France,   Germany,   Greece,   Norway,   Russian Federation,   Spain,   Sweden,   Switzerland,   Turkey,   United Kingdom
Removed Location Countries  
 
Administrative Information
NCT Number NCT00882336
Other Study ID Numbers NIS-CEU-DUM-2008/1
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Current Responsible Party MSD, AstraZeneca
Original Responsible Party Same as current
Current Study Sponsor AstraZeneca
Original Study Sponsor Same as current
Collaborators Not Provided
Investigators
Study Director: Elvira Massó AstraZeneca Spain
PRS Account AstraZeneca
Verification Date October 2009