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
  Purpose

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.


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

Study Type: Observational
Study Design: Time Perspective: Retrospective
Official Title: Dyslipaemia, Atherosclerosis Risk and Increased hsCRP and Inflammatory and Oxidative Status in the Spanish Population

Resource links provided by NLM:


Further study details as provided by AstraZeneca:

Primary Outcome Measures:
  • Lipid fractions: high-density lipoprotein, low-density lipoprotein, and total cholesterol, and triglycerides, and dislipidemia treatments [ Time Frame: retrospectively ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ]

Biospecimen Retention:   None Retained

No samples will be obtained, but biomarkers will be analysed from frozen serum samples retained by the pervious studies performed.


Estimated Enrollment: 30181
Study Start Date: November 2009
Study Completion Date: October 2011
Primary Completion Date: October 2011 (Final data collection date for primary outcome measure)
Groups/Cohorts
1
Data from epidemiological studies performed after the year 2000 with patients between 35 and 74 years old

  Eligibility

Ages Eligible for Study:   35 Years to 74 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

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

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00998062

Locations
Spain
Research Site
Talavero, Castilla la Mancha, Spain
Research Site
Castilla y Leon, Castilla Leon, Spain
Research Site
Girona, Cataluna, Spain
Research Site
Hospitalet, Cataluna, Spain
Research Site
Badajoz, Extremadura, Spain
Research Site
Andalucia, Spain
Research Site
Canarias, Spain
Research Site
Madrid, Spain
Research Site
Mallorca, Spain
Research Site
Murcia, Spain
Research Site
Navarra, Spain
Sponsors and Collaborators
AstraZeneca
  More Information

No publications provided

Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT00998062     History of Changes
Other Study ID Numbers: NIS-CES-DUM-2009/1
Study First Received: October 19, 2009
Last Updated: October 19, 2011
Health Authority: Spain: Ethics Committee

Keywords provided by AstraZeneca:
Dyslipaemia
atherosclerosis risk
increased hsCRP
inflammatory and oxidative status in the Spanish population

Additional relevant MeSH terms:
Atherosclerosis
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on August 21, 2014