Clinical trial NCT00882336: European Study of Cardiovascular Risk
Official title: Epidemiological Study of European Cardiovascular Risk Patients: Disease Prevention and Management in Usual Daily Practice
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cardiovascular Risk Factors
Hyperlipidemia
Hypertension
Diabetes
Obesity
Smoking
Keywords: Cardiovascular risk management
Hyperlipidemia
Hypertension
Diabetes
Obesity
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2009-04-16
Enrollment: 7200
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Time perspective: CROSS_SECTIONAL
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.

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.


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

Primary outcomes:
measure: LDL-cholesterol, systolic and diastolic blood pressure, Tot. cholesterol, Non-HDL cholesterol, HDL-cholesterol, waist and hip circumference, HbA1c
timeFrame: Cross-sectional
measure: Gender, age, patients with diabetes and/or hypertension (%), smoker status, family medical history.
timeFrame: Cross-sectional
Secondary outcomes:
measure: BMI, Score based 10 year CHD mortality > 5%, High Risk patients (no. and %)
timeFrame: Cross-sectional
measure: Use of concomitant medication: anticoagulant, anti hypertensive, antidiabetic, lipid-lowering drugs
timeFrame: Cross-sectional
measure: Biomarkers: Apo-A1, Apo-B, Hs-CRP, Creatinine, albuminuria, uric acid, glomerular filtration rate.
timeFrame: Cross-sectional
Other outcomes:
Locations:
city: Alland
country: Austria
facility: Research Site
city: Bad VOslau
country: Austria
facility: Research Site
city: Baden bei Wien
country: Austria
facility: Research Site
city: Bierbaum am Auersbach
country: Austria
facility: Research Site
city: Bludenz
country: Austria
facility: Research Site
city: Deutsch Jahrndorf
country: Austria
facility: Research Site
city: Feldkirch
country: Austria
facility: Research Site
city: Forstau
country: Austria
facility: Research Site
city: Frankenmarkt
country: Austria
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city: FUrstenfeld
country: Austria
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city: Gerasdorf bei Wien
country: Austria
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city: Gleisdorf
country: Austria
facility: Research Site
city: Graz, Geidorf
country: Austria
facility: Research Site
city: Graz, Gries
country: Austria
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city: Graz, Strassgang
country: Austria
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city: Graz, Waltendorf
country: Austria
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city: Graz
country: Austria
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city: Gross-Enzersdorf
country: Austria
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city: Guntramsdorf
country: Austria
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city: GUssing
country: Austria
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city: Haid bei Ansfelden
country: Austria
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city: Hallein
country: Austria
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city: Handenberg
country: Austria
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city: Hard, Vbg
country: Austria
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country: Austria
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city: Hohenau an der March
country: Austria
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country: Austria
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city: Jenbach
country: Austria
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city: Judendorf-Strassengel
country: Austria
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country: Austria
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country: Austria
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city: Klagenfurt, St. Martin
country: Austria
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country: Austria
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city: KOstendorf / Sbg
country: Austria
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city: Kraig
country: Austria
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city: Krems an der Donau
country: Austria
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city: Laab im Walde
country: Austria
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country: Austria
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city: Linz, Donau
country: Austria
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country: Austria
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country: Austria
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country: Austria
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country: Austria
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country: Austria
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city: Pyhra, Bez. St. POlten
country: Austria
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country: Austria
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country: Austria
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country: Austria
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country: Austria
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city: St. Leonhard am Forst
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city: Wien, Alsergrund
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country: Austria
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city: Wien, Floridsdorf
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city: Wien, Innere Stadt
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city: Wien, Landstrasse
country: Austria
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city: Wien, Leopoldstadt
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city: Wien, Meidling
country: Austria
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city: Wien, Neubau
country: Austria
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city: Wien, Ottakring
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city: Wien, Penzing
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city: Wiener Neustadt
country: Austria
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city: Wien
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city: Ziersdorf
country: Austria
facility: Research Site
city: Aalst
country: Belgium
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city: Aalter
country: Belgium
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city: Anthee
country: Belgium
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city: ATH
country: Belgium
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city: Beauvechain
country: Belgium
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city: Bellaire
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city: Berchem (antwerpen)
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city: Braine-le-comte
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city: Brugge
country: Belgium
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city: Bruxelles
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city: Ceroux-Mousty
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city: Champion
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city: Deurne (antwerpen)
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city: Kruishoutem
country: Belgium
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city: Leignon
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city: Sambreville
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city: St-maria-oudenhove (zot.)
country: Belgium
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country: Belgium
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city: Thieusies
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city: Tongeren
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city: Vaux-sous-chevremont
country: Belgium
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city: Velm
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city: Verviers
country: Belgium
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city: Veurne
country: Belgium
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city: Villers-la-ville
country: Belgium
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city: Vorst (kempen)
country: Belgium
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city: Wilrijk (antwerpen)
country: Belgium
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city: Zemst
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city: Zonhoven
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city: Agen
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city: Aix En Provence
country: France
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country: France
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country: France
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country: France
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city: Auzeville Tolosane
country: France
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city: Besancon
country: France
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country: France
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country: France
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country: France
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city: Clermont Ferrand Cedex 1
country: France
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country: France
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country: France
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country: France
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country: France
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country: France
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country: France
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country: France
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country: France
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country: France
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country: France
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city: Kunheim
country: France
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city: La Baule
country: France
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city: La Ferte St Aubin
country: France
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city: La Riviere St Sauveur
country: France
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city: Labergement Ste Marie
country: France
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country: France
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city: Les Milles
country: France
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city: Lourmarin
country: France
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city: Lyon
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city: Maizieres Les Metz
country: France
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city: Mauriac
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city: Meaux
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city: Mery Sur Seine
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city: Metz -tessy Cedex
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city: Montpellier Cedex 5
country: France
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city: Montreuil
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city: Mornas
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city: Nice Cedex 2
country: France
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city: Orange
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city: Paris Cedex 10
country: France
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city: Paris Cedex 18
country: France
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city: Paris
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country: Germany
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country: Germany
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country: Germany
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country: Germany
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country: Germany
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country: Germany
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country: Germany
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country: Germany
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country: Germany
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country: United Kingdom
facility: Research Site
Study officials:
affiliation: AstraZeneca Spain
name: Elvira Massó
role: STUDY_DIRECTOR
References:
citation: Halcox JP, Banegas JR, Roy C, Dallongeville J, De Backer G, Guallar E, Perk J, Hajage D, Henriksson KM, Borghi C. Prevalence and treatment of atherogenic dyslipidemia in the primary prevention of cardiovascular disease in Europe: EURIKA, a cross-sectional observational study. BMC Cardiovasc Disord. 2017 Jun 17;17(1):160. doi: 10.1186/s12872-017-0591-5.
citation: Borghi C, Rodriguez-Artalejo F, De Backer G, Dallongeville J, Medina J, Guallar E, Perk J, Banegas JR, Tubach F, Roy C, Halcox JP. The association between blood pressure and lipid levels in Europe: European Study on Cardiovascular Risk Prevention and Management in Usual Daily Practice. J Hypertens. 2016 Nov;34(11):2155-63. doi: 10.1097/HJH.0000000000001078.
citation: Borghi C, Tubach F, De Backer G, Dallongeville J, Guallar E, Medina J, Perk J, Roy C, Banegas JR, Rodriguez-Artalejo F, Halcox JP. Lack of control of hypertension in primary cardiovascular disease prevention in Europe: Results from the EURIKA study. Int J Cardiol. 2016 Sep 1;218:83-88. doi: 10.1016/j.ijcard.2016.05.044. Epub 2016 May 13.
citation: Halcox JP, Tubach F, Lopez-Garcia E, De Backer G, Borghi C, Dallongeville J, Guallar E, Medina J, Perk J, Sazova O, Sweet S, Roy C, Banegas JR, Rodriguez-Artalejo F. Low rates of both lipid-lowering therapy use and achievement of low-density lipoprotein cholesterol targets in individuals at high-risk for cardiovascular disease across Europe. PLoS One. 2015 Feb 18;10(2):e0115270. doi: 10.1371/journal.pone.0115270. eCollection 2015.
citation: Halcox JP, Roy C, Tubach F, Banegas JR, Dallongeville J, De Backer G, Guallar E, Sazova O, Medina J, Perk J, Steg PG, Rodriguez-Artalejo F, Borghi C. C-reactive protein levels in patients at cardiovascular risk: EURIKA study. BMC Cardiovasc Disord. 2014 Feb 24;14:25. doi: 10.1186/1471-2261-14-25.
citation: Halcox JP, Tubach F, Sazova O, Sweet S, Medina J; EURIKA steering committee. Reclassification of European patients' cardiovascular risk using the updated Systematic Coronary Risk Evaluation algorithm. Eur J Prev Cardiol. 2015 Feb;22(2):200-2. doi: 10.1177/2047487313507680. Epub 2013 Oct 3.
citation: Schmieder RE, Goebel M, Bramlage P. Barriers to cardiovascular risk prevention and management in Germany--an analysis of the EURIKA study. Vasc Health Risk Manag. 2012;8:177-86. doi: 10.2147/VHRM.S29915. Epub 2012 Mar 15.
citation: Dallongeville J, Banegas JR, Tubach F, Guallar E, Borghi C, De Backer G, Halcox JP, Masso-Gonzalez EL, Perk J, Sazova O, Steg PG, Artalejo FR; EURIKA Investigators. Survey of physicians' practices in the control of cardiovascular risk factors: the EURIKA study. Eur J Prev Cardiol. 2012 Jun;19(3):541-50. doi: 10.1177/1741826711407705. Epub 2011 Apr 18.
citation: Rodriguez-Artalejo F, Guallar E, Borghi C, Dallongeville J, De Backer G, Halcox JP, Hernandez-Vecino R, Jimenez FJ, Masso-Gonzalez EL, Perk J, Steg PG, Banegas JR; EURIKA Investigators. Rationale and methods of the European Study on Cardiovascular Risk Prevention and Management in Daily Practice (EURIKA). BMC Public Health. 2010 Jun 30;10:382. doi: 10.1186/1471-2458-10-382.