NCT00998062

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30,181

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Nov 2009

Geographic Reach
1 country

11 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 19, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 20, 2009

Completed
12 days until next milestone

Study Start

First participant enrolled

November 1, 2009

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2011

Completed
Last Updated

October 20, 2011

Status Verified

October 1, 2011

Enrollment Period

1.9 years

First QC Date

October 19, 2009

Last Update Submit

October 19, 2011

Conditions

Keywords

Dyslipaemiaatherosclerosis riskincreased hsCRPinflammatory and oxidative status in the Spanish population

Outcome Measures

Primary Outcomes (1)

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

    retrospectively

Secondary Outcomes (3)

  • 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

Study Arms (1)

1

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

Eligibility Criteria

Age35 Years - 74 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

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

You may qualify if:

  • 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

You may not qualify if:

  • Spanish population outside the age range
  • Data from Epidemiological studies performed before the year 2000

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (11)

Research Site

Andalucia, Andalusia, Spain

Location

Research Site

Canarias, Canary Islands, Spain

Location

Research Site

Castilla Y Leon, Castille and León, Spain

Location

Research Site

Talavero, Castille-La Mancha, Spain

Location

Research Site

Girona, Catalonia, Spain

Location

Research Site

Hospitalet, Catalonia, Spain

Location

Research Site

Badajoz, Extremadura, Spain

Location

Research Site

Madrid, Madrid, Spain

Location

Research Site

Mallorca, Mallorca, Spain

Location

Research Site

Murcia, Murcia, Spain

Location

Research Site

Navarra, Navarre, Spain

Location

Biospecimen

Retention: NONE RETAINED

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

Study Design

Study Type
observational
Time Perspective
RETROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 19, 2009

First Posted

October 20, 2009

Study Start

November 1, 2009

Primary Completion

October 1, 2011

Study Completion

October 1, 2011

Last Updated

October 20, 2011

Record last verified: 2011-10

Locations