Dyslipaemia, Atherosclerosis Risk and Increased hsCRP and Inflammatory and Oxidative Status in the Spanish Population. Database Analysis of Previous Studies Performed in Spain (DARIOS)

This study has been completed.

Sponsor:

Information provided by (Responsible Party):

AstraZeneca

ClinicalTrials.gov Identifier:

NCT00998062

First received: October 19, 2009

Last updated: October 19, 2011

Last verified: October 2011

History of Changes

Tracking Information
First Received Date ^ICMJE	October 19, 2009
Last Updated Date	October 19, 2011
Start Date ^ICMJE	November 2009
Primary Completion Date	October 2011 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: October 19, 2009)	Lipid fractions: high-density lipoprotein, low-density lipoprotein, and total cholesterol, and triglycerides, and dislipidemia treatments [ Time Frame: retrospectively ] [ Designated as safety issue: No ]
Original Primary Outcome Measures ^ICMJE	Same as current
Change History	Complete list of historical versions of study NCT00998062 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE (submitted: October 19, 2009)	High sensitivity C reactive protein & CHR risk by Framingham adapted functions [ Time Frame: retrospectively ] [ Designated as safety issue: No ] Lipid profile among the Spanish regions, as in the primary outcome variable [ Time Frame: retrospectively ] [ Designated as safety issue: No ] Biomarkers: Interleukines 6 and 10, oxidized LDL, VCAM, ICAM, TNF alpha, neopterin, fibrinogen, lp(a), MMP 9 Apo A, Apo B, adiponectin, leptin, resistin, and yet other [ Time Frame: prospectively ] [ Designated as safety issue: No ]
Original Secondary Outcome Measures ^ICMJE	Same as current
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	Dyslipaemia, Atherosclerosis Risk and Increased hsCRP and Inflammatory and Oxidative Status in the Spanish Population. Database Analysis of Previous Studies Performed in Spain
Official Title ^ICMJE	Dyslipaemia, Atherosclerosis Risk and Increased hsCRP and Inflammatory and Oxidative Status in the Spanish Population
Brief Summary	The present project is aimed at determining the prevalence of LDL-C <130 mg/dl with hsCRP ≥2mg/l, and of HDL-C < 40 mg/dl in Spain together with the estimation of cardiovascular risk, to analyze the contribution of measuring hsCRP for primary prevention purposes. In a subgroup of that population a number of inflammatory and oxidative status biomarkers would be also measured to better understand the meaning of elevated hsCRP.The study aim to analyze data already collected in studies (11 studies will participate) carried out in Spain, in 10 Spanish regions, after the year 2000.
Detailed Description	Not Provided
Study Type ^ICMJE	Observational
Study Design ^ICMJE	Time Perspective: Retrospective
Target Follow-Up Duration	Not Provided
Biospecimen	Retention: None Retained Description: No samples will be obtained, but biomarkers will be analysed from frozen serum samples retained by the pervious studies performed.
Sampling Method	Probability Sample
Study Population	Data from epidemiological studies performed after the year 2000 with patients between 35 and 74 years old
Condition ^ICMJE	Dyslipaemia Atherosclerosis Risk Increased hsCRP Inflammatory and Oxidative Status in the Spanish Population
Intervention ^ICMJE	Not Provided
Study Group/Cohort (s)	1 Data from epidemiological studies performed after the year 2000 with patients between 35 and 74 years old
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Completed
Estimated Enrollment ^ICMJE	30181
Completion Date	October 2011
Primary Completion Date	October 2011 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	Inclusion Criteria: Have an Informed consent form signed when the patient accepted to participate in the study already performed. Spanish population between Data from Epidemiological studies performed after the year 2000 Exclusion Criteria: Spanish population outside the age range Data from Epidemiological studies performed before the year 2000
Gender	Both
Ages	35 Years to 74 Years
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	Spain

Administrative Information
NCT Number ^ICMJE	NCT00998062
Other Study ID Numbers ^ICMJE	NIS-CES-DUM-2009/1
Has Data Monitoring Committee	No
Responsible Party	AstraZeneca
Study Sponsor ^ICMJE	AstraZeneca
Collaborators ^ICMJE	Not Provided
Investigators ^ICMJE	Not Provided
Information Provided By	AstraZeneca
Verification Date	October 2011
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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