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

Atherosclerosis Risk Clinical Trial

— DARIOS  

Official title:

Dyslipaemia, Atherosclerosis Risk and Increased hsCRP and Inflammatory and Oxidative Status in the Spanish Population

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00998062
• Other study ID #: NIS-CES-DUM-2009/1
• Status: Completed
• Phase: N/A
• First received: October 19, 2009
• Last updated: October 19, 2011
• Start date: November 2009
• Est. completion date: October 2011

Study information

• Verified date: October 2011
• Source: AstraZeneca
• Contact: n/a
• Is FDA regulated: No
• Health authority: Spain: Ethics Committee
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30181
• Est. completion date: October 2011
• Est. primary completion date: October 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 35 Years to 74 Years

Eligibility

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

Study Design

Time Perspective: Retrospective

Related Conditions & MeSH terms

• Atherosclerosis
• Atherosclerosis Risk
• Dyslipaemia
• Increased hsCRP
• Inflammatory and Oxidative Status in the Spanish Population

Locations

Country	Name	City	State
Spain	Research Site	Andalucia
Spain	Research Site	Badajoz	Extremadura
Spain	Research Site	Canarias
Spain	Research Site	Castilla y Leon	Castilla Leon
Spain	Research Site	Girona	Cataluna
Spain	Research Site	Hospitalet	Cataluna
Spain	Research Site	Madrid
Spain	Research Site	Mallorca
Spain	Research Site	Murcia
Spain	Research Site	Navarra
Spain	Research Site	Talavero	Castilla la Mancha

Sponsors (1)

Lead Sponsor	Collaborator
AstraZeneca

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Lipid fractions: high-density lipoprotein, low-density lipoprotein, and total cholesterol, and triglycerides, and dislipidemia treatments		retrospectively	No
Secondary	High sensitivity C reactive protein & CHR risk by Framingham adapted functions		retrospectively	No
Secondary	Lipid profile among the Spanish regions, as in the primary outcome variable		retrospectively	No
Secondary	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		prospectively	No