DyslipaemiaDARIOSNCT00998062
Dyslipaemia, Atherosclerosis Risk and Increased hsCRP and Inflammatory and Oxidative Status in the Spanish Population. Database Analysis of Previous Studies Performed in Spain
An observational study of Dyslipaemia and Atherosclerosis Risk, run by AstraZeneca at 11 sites in Spain.
Trial 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. Read more about this study
- Who is it for?
- Ages 35 to 74 years
- Conditions the study is for
- Dyslipaemia, Atherosclerosis Risk, Increased hsCRP
- How many people
- 30,181 participants
- Where
- 11 sitesSpain
- Study dates
- Nov 2009to Oct 2011
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 35 to 74 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Data from epidemiological studies performed after the year 2000 with patients between 35 and 74 years old
Who may be able to join
- 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
Who cannot join
- Spanish population outside the age range
- Data from Epidemiological studies performed before the year 2000
Trial locations and contacts
11 sites in 1 country.
11 sites in 1 country
Spain11 sites
Research Site
Andalucia, Andalusia
Research Site
Badajoz, Extremadura
Research Site
Canarias, Canary Islands
Research Site
Castilla Y Leon, Castille and León
Research Site
Girona, Catalonia
Research Site
Hospitalet, Catalonia
Research Site
Madrid, Madrid
Research Site
Mallorca, Mallorca
Research Site
Murcia, Murcia
Research Site
Navarra, Navarre
Research Site
Talavero, Castille-La Mancha
About this study
Official title: 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.
- 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
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Data from epidemiological studies performed after the year 2000 with patients between 35 and 74 years old |
What is being measured
The primary outcome is the main question the study is designed to answer.
Lipid fractions: high-density lipoprotein, low-density lipoprotein, and total cholesterol, and triglycerides, and dislipidemia treatments
Measured: retrospectively
Secondary outcomes (3)
High sensitivity C reactive protein & CHR risk by Framingham adapted functions
Measured: retrospectively
Lipid profile among the Spanish regions, as in the primary outcome variable
Measured: 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
Measured: prospectively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Oct 2009 (estimated)
- Study startNov 2009
- Primary completionOct 2011
- Study completionOct 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DyslipaemiaStudies of the same condition, open and under way.
- More trials run by AstraZenecaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Time perspective
- Retrospective
- Enrolment
- 30,181 participants (estimated)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00998062
- Sponsor's protocol ID
- NIS-CES-DUM-2009/1
- Acronym
- DARIOS
- Status last verified
- Oct 2011
- First submitted
- 19 Oct 2009
- Last updated
- 20 Oct 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Oct 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dyslipaemia, Atherosclerosis Risk and Increased hsCRP and Inflammatory and Oxidative Status in the Spanish Population
- ClinicalTrials.gov ID
- NCT00998062
- Acronym / sponsor ID
- DARIOS / NIS-CES-DUM-2009/1
- 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
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 30,181 participants (estimated)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- Nov 2009
- Primary completion
- Oct 2011 (actual)
- Study completion
- Oct 2011 (actual)
- First posted
- 20 Oct 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | – | –Data from epidemiological studies performed after the year 2000 with patients between 35 and 74 years old |
Who may qualify
- Ages
- 35 to 74 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Data from epidemiological studies performed after the year 2000 with patients between 35 and 74 years old
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (2 listed)
- Spanish population outside the age range
- Data from Epidemiological studies performed before the year 2000
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Lipid fractions: high-density lipoprotein, low-density lipoprotein, and total cholesterol, and triglycerides, and dislipidemia treatments
Time frame: retrospectively
3 secondary outcomes
High sensitivity C reactive protein & CHR risk by Framingham adapted functions
Time frame: retrospectively
Lipid profile among the Spanish regions, as in the primary outcome variable
Time frame: 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
Time frame: prospectively
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Oct 2011.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
11 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Dyslipaemia and Atherosclerosis Risk, run by AstraZeneca at 11 sites in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Oct 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 11 sites in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Lipid fractions: high-density lipoprotein, low-density lipoprotein, and total cholesterol, and triglycerides, and dislipidemia treatments (time frame: retrospectively). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Oct 2011.