European Study of Cardiovascular Risk - Full Text View

Sponsored by:	AstraZeneca
Information provided by:	AstraZeneca
ClinicalTrials.gov Identifier:	NCT00882336

Purpose

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.

Condition
Cardiovascular Risk Factors Hyperlipidemia Hypertension Diabetes Obesity Smoking

MedlinePlus related topics: Cholesterol Diabetes High Blood Pressure Obesity Smoking

U.S. FDA Resources

Study Type:	Observational
Study Design:	Cross-Sectional
Official Title:	Epidemiological Study of European Cardiovascular Risk Patients: Disease Prevention and Management in Usual Daily Practice

Further study details as provided by AstraZeneca:

Primary Outcome Measures:

LDL-cholesterol, systolic and diastolic blood pressure, Tot. cholesterol, Non-HDL cholesterol, HDL-cholesterol, waist and hip circumference, HbA1c [ Time Frame: Cross-sectional ] [ Designated as safety issue: No ]
Gender, age, patients with diabetes and/or hypertension (%), smoker status, family medical history. [ Time Frame: Cross-sectional ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

BMI, Score based 10 year CHD mortality > 5%, High Risk patients (no. and %) [ Time Frame: Cross-sectional ] [ Designated as safety issue: No ]
Use of concomitant medication: anticoagulant, anti hypertensive, antidiabetic, lipid-lowering drugs [ Time Frame: Cross-sectional ] [ Designated as safety issue: No ]
Biomarkers: Apo-A1, Apo-B, Hs-CRP, Creatinine, albuminuria, uric acid, glomerular filtration rate. [ Time Frame: Cross-sectional ] [ Designated as safety issue: No ]

Biospecimen Retention: Samples Without DNA

Biospecimen Description:

Whole blood Serum

Estimated Enrollment:	7200
Study Start Date:	May 2009
Estimated Study Completion Date:	September 2009

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)

Eligibility

Ages Eligible for Study:	50 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No
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.

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00882336

Contacts

Contact: AstraZeneca Spain Clinical Study Information

+34913019078

Pilar.Solana@astrazeneca.com

Sponsors and Collaborators

AstraZeneca

Investigators

Study Director:

Elvira Massó

AstraZeneca Spain

More Information

No publications provided

Responsible Party:	AstraZeneca ( MSD )
Study ID Numbers:	NIS-CEU-DUM-2008/1
Study First Received:	April 15, 2009
Last Updated:	April 15, 2009
ClinicalTrials.gov Identifier:	NCT00882336 History of Changes
Health Authority:	Austria: Ethikkommission; Switzerland: Ethikkommission; Germany: Ethics Commission; Turkey: Ethics Committee; United Kingdom: Research Ethics Committee; United Kingdom: National Health Service; Belgium: Institutional Review Board; Sweden: Regional Ethical Review Board; Norway: The National Committees for Research Ethics in Norway; France: Institutional Ethical Committee; France: French Data Protection Authority; Greece: Ethics Committee; Greece: Ministry of Health and Welfare; Spain: Ethics Committee; Russia: Ethics Committee

Keywords provided by AstraZeneca:

Cardiovascular risk management
Hyperlipidemia
Hypertension
Diabetes
Obesity

Study placed in the following topic categories:

Obesity
Hyperlipidemias
Metabolic Diseases
Diabetes Mellitus
Vascular Diseases
Overweight
Body Weight
Signs and Symptoms

Smoking
Nutrition Disorders
Overnutrition
Metabolic Disorder
Dyslipidemias
Hypertension
Lipid Metabolism Disorders

Additional relevant MeSH terms:

Obesity
Hyperlipidemias
Metabolic Diseases
Vascular Diseases
Overweight
Body Weight
Signs and Symptoms

Nutrition Disorders
Cardiovascular Diseases
Overnutrition
Dyslipidemias
Hypertension
Lipid Metabolism Disorders

ClinicalTrials.gov processed this record on May 06, 2009