Clinical trial NCT00998062: 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: Dyslipaemia, Atherosclerosis Risk and Increased hsCRP and Inflammatory and Oxidative Status in the Spanish Population
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Dyslipaemia
Atherosclerosis Risk
Increased hsCRP
Inflammatory and Oxidative Status in the Spanish Population
Keywords: Dyslipaemia
atherosclerosis risk
increased hsCRP
inflammatory and oxidative status in the Spanish population
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2009-10-20
Enrollment: 30181
Sex: ALL
Minimum age (years): 35
Maximum age (years): 74
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Data from epidemiological studies performed after the year 2000 with patients between 35 and 74 years old

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.


Eligibility criteria: 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

Primary outcomes:
measure: Lipid fractions: high-density lipoprotein, low-density lipoprotein, and total cholesterol, and triglycerides, and dislipidemia treatments
timeFrame: retrospectively
Secondary outcomes:
measure: High sensitivity C reactive protein & CHR risk by Framingham adapted functions
timeFrame: retrospectively
measure: Lipid profile among the Spanish regions, as in the primary outcome variable
timeFrame: retrospectively
measure: 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
timeFrame: prospectively
Other outcomes:
Locations:
city: Talavero
country: Spain
facility: Research Site
state: Castilla la Mancha
city: Castilla y Leon
country: Spain
facility: Research Site
state: Castilla Leon
city: Girona
country: Spain
facility: Research Site
state: Cataluna
city: Hospitalet
country: Spain
facility: Research Site
state: Cataluna
city: Badajoz
country: Spain
facility: Research Site
state: Extremadura
city: Andalucia
country: Spain
facility: Research Site
city: Canarias
country: Spain
facility: Research Site
city: Madrid
country: Spain
facility: Research Site
city: Mallorca
country: Spain
facility: Research Site
city: Murcia
country: Spain
facility: Research Site
city: Navarra
country: Spain
facility: Research Site
Study officials:
References: