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Completed

NCT Number: NCT00998062

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

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.

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Key information

Conditions

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

Age range

35 year–74 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Research Site, Andalucia, Andalusia, Spain

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Lipid fractions: high-density lipoprotein, low-density lipoprotein, and total cholesterol, and triglycerides, and dislipidemia treatments

    Time frame: retrospectively

Secondary outcomes

  1. High sensitivity C reactive protein & CHR risk by Framingham adapted functions

    Time frame: retrospectively

  2. Lipid profile among the Spanish regions, as in the primary outcome variable

    Time frame: retrospectively

  3. 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

Sponsors and collaborators

Lead sponsor

AstraZeneca

Industry

Registry information

Official study title

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

Acronym: DARIOS

Important dates

Study start
2009
Primary completion
2011
Study completion
2011
First posted
Oct 20, 2009
Registry last updated
Oct 20, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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