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

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

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.

Study Overview

• Status: Completed
• Conditions: Dyslipaemia; Atherosclerosis Risk; Increased hsCRP; Inflammatory and Oxidative Status in the Spanish Population

• Study Type: Observational
• Enrollment (Anticipated): 30181

Contacts and Locations

Study Locations

• Spain
  • Andalucia, Spain
    • Research Site
  • Canarias, Spain
    • Research Site
  • Madrid, Spain
    • Research Site
  • Mallorca, Spain
    • Research Site
  • Murcia, Spain
    • Research Site
  • Navarra, Spain
    • Research Site
  • Castilla Leon
    • Castilla y Leon, Castilla Leon, Spain
      • Research Site
  • Castilla la Mancha
    • Talavero, Castilla la Mancha, Spain
      • Research Site
  • Cataluna
    • Girona, Cataluna, Spain
      • Research Site
    • Hospitalet, Cataluna, Spain
      • Research Site
  • Extremadura
    • Badajoz, Extremadura, Spain
      • Research Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 35 years to 74 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Data from epidemiological studies performed after the year 2000 with patients between 35 and 74 years old

Description

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 Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
1; Data from epidemiological studies performed after the year 2000 with patients between 35 and 74 years old

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Lipid fractions: high-density lipoprotein, low-density lipoprotein, and total cholesterol, and triglycerides, and dislipidemia treatments	retrospectively

Secondary Outcome Measures

Outcome Measure	Time Frame
High sensitivity C reactive protein & CHR risk by Framingham adapted functions	retrospectively
Lipid profile among the Spanish regions, as in the primary outcome variable	retrospectively
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

Collaborators and Investigators

• Sponsor: AstraZeneca

Study record dates

Study Major Dates

• Study Start: November 1, 2009
• Primary Completion (Actual): October 1, 2011
• Study Completion (Actual): October 1, 2011

Study Registration Dates

• First Submitted: October 19, 2009
• First Submitted That Met QC Criteria: October 19, 2009
• First Posted (Estimate): October 20, 2009

Study Record Updates

• Last Update Posted (Estimate): October 20, 2011
• Last Update Submitted That Met QC Criteria: October 19, 2011
• Last Verified: October 1, 2011

More Information

Terms related to this study

• Keywords: atherosclerosis risk; Dyslipaemia; increased hsCRP; inflammatory and oxidative status in the Spanish population
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Atherosclerosis
• Other Study ID Numbers: NIS-CES-DUM-2009/1