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Cardiovascular DiseaseENRICANCT01133093

Study on Nutrition and Cardiovascular Risk in Spain.

An observational study of Cardiovascular Disease, run by Universidad Autonoma de Madrid at 1 site in Spain.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The purpose of this study is to assess the distribution, awareness and control of main cardiovascular risk factors in the Spanish population. The main study variables are: Lifestyles (tobacco, alcohol, nutrition, physical activity) Biological risk factors either well-established (blood lipids, glucose, insulin and… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Cardiovascular Disease
How many people
11,991 participants
Where
1 siteSpain
Study dates
Mar 2008to Oct 2010
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 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: Community sample representative of the non-institutionalized Spanish population

Who may be able to join

  • Non-institutionalized Spanish resident
  • 18 years and over

Who cannot join

  • None

Trial locations and contacts

1 site in 1 country.

Spain1 site

  • Department of Preventive Medicine and Public Health. Universidad Autonoma de Madrid

    Madrid, Madrid, 28029

Other trials in Spain

About this study

The purpose of this study is to assess the distribution, awareness and control of main cardiovascular risk factors in the Spanish population. The main study variables are:

  • Lifestyles (tobacco, alcohol, nutrition, physical activity)
  • Biological risk factors either well-established (blood lipids, glucose, insulin and blood pressure) or emergent (leptin, C-reactive protein and other markers of inflammation)
Read the detailed description

Data collection comprised 3 sequential stages:

  1. computer-assisted telephone interview to obtain information on lifestyle, knowledge and attitudes about cardiovascular disease risk factors, and the signs and symptoms of heart attack and stroke, subjective health, and morbidity;
  2. first homevisit, to collect blood and urine samples for analysis by a central laboratory;
  3. second home visit, to measure anthropometric variables and blood pressure and to administer a computer-assisted dietary history; data on functional limitations are also collected from participants aged 65 years and older.
Keywords
Cardiovascular risk factors, Nutritional assessment, Epidemiology
Medical subject headings
Cardiovascular Diseases

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Cardiovascular Risk Factors Control

    Measured: 2 years

  2. Health-related quality of life

    Measured: 2 years

  3. Use of health care services

    Measured: 2 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted28 May 2010 (estimated)
  2. Study startMar 2008
  3. Primary completionJun 2008
  4. Study completionOct 2010

Resources

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
Cross-sectional
Enrolment
11,991 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01133093
Sponsor's protocol ID
ENRICA
Acronym
ENRICA
Status last verified
May 2016
First submitted
27 May 2010
Last updated
6 May 2016
Results posted
No
Data monitoring committee
Yes
Individual data sharing
Undecided

Publications

  • Gutierrez-Fisac JL, Guallar-Castillon P, Leon-Munoz LM, Graciani A, Banegas JR, Rodriguez-Artalejo F. Prevalence of general and abdominal obesity in the adult population of Spain, 2008-2010: the ENRICA study. Obes Rev. 2012 Apr;13(4):388-92. doi: 10.1111/j.1467-789X.2011.00964.x. Epub 2011 Dec 12.

    PubMed 22151906

  • Guallar-Castillon P, Gil-Montero M, Leon-Munoz LM, Graciani A, Bayan-Bravo A, Taboada JM, Banegas JR, Rodriguez-Artalejo F. Magnitude and management of hypercholesterolemia in the adult population of Spain, 2008-2010: The ENRICA Study. Rev Esp Cardiol (Engl Ed). 2012 Jun;65(6):551-8. doi: 10.1016/j.recesp.2012.02.005. Epub 2012 Apr 5.

    PubMed 22483404

  • Leon-Munoz LM, Guallar-Castillon P, Graciani A, Lopez-Garcia E, Mesas AE, Aguilera MT, Banegas JR, Rodriguez-Artalejo F. Adherence to the Mediterranean diet pattern has declined in Spanish adults. J Nutr. 2012 Oct;142(10):1843-50. doi: 10.3945/jn.112.164616. Epub 2012 Aug 8.

    PubMed 22875552

  • Banegas JR, Graciani A, de la Cruz-Troca JJ, Leon-Munoz LM, Guallar-Castillon P, Coca A, Ruilope LM, Rodriguez-Artalejo F. Achievement of cardiometabolic goals in aware hypertensive patients in Spain: a nationwide population-based study. Hypertension. 2012 Oct;60(4):898-905. doi: 10.1161/HYPERTENSIONAHA.112.193078. Epub 2012 Sep 4.

    PubMed 22949530

  • Mesas AE, Leon-Munoz LM, Guallar-Castillon P, Graciani A, Gutierrez-Fisac JL, Lopez-Garcia E, Aguilera MT, Banegas JR, Rodriguez-Artalejo F. Obesity-related eating behaviours in the adult population of Spain, 2008-2010. Obes Rev. 2012 Oct;13(10):858-67. doi: 10.1111/j.1467-789X.2012.01005.x. Epub 2012 May 11.

    PubMed 22577840

  • Lundelin K, Graciani A, Garcia-Puig J, Guallar-Castillon P, Taboada JM, Rodriguez-Artalejo F, Banegas JR. Knowledge of stroke warning symptoms and intended action in response to stroke in Spain: a nationwide population-based study. Cerebrovasc Dis. 2012;34(2):161-8. doi: 10.1159/000341408. Epub 2012 Aug 17.

    PubMed 22907330

  • Navarro-Vidal B, Banegas JR, Leon-Munoz LM, Rodriguez-Artalejo F, Graciani A. Achievement of cardiometabolic goals among diabetic patients in Spain. A nationwide population-based study. PLoS One. 2013 Apr 18;8(4):e61549. doi: 10.1371/journal.pone.0061549. Print 2013.

    PubMed 23637851

  • Graciani A, Leon-Munoz LM, Guallar-Castillon P, Rodriguez-Artalejo F, Banegas JR. Cardiovascular health in a southern Mediterranean European country: a nationwide population-based study. Circ Cardiovasc Qual Outcomes. 2013 Jan 1;6(1):90-8. doi: 10.1161/CIRCOUTCOMES.112.967893. Epub 2013 Jan 8.

    PubMed 23300271

  • Lopez-Garcia E, Guallar-Castillon P, Leon-Munoz L, Rodriguez-Artalejo F. Prevalence and determinants of metabolically healthy obesity in Spain. Atherosclerosis. 2013 Nov;231(1):152-7. doi: 10.1016/j.atherosclerosis.2013.09.003. Epub 2013 Sep 18.

    PubMed 24125427

  • Soler-Vila H, Galan I, Valencia-Martin JL, Leon-Munoz LM, Guallar-Castillon P, Rodriguez-Artalejo F. Binge drinking in Spain, 2008-2010. Alcohol Clin Exp Res. 2014 Mar;38(3):810-9. doi: 10.1111/acer.12275. Epub 2013 Oct 24.

    PubMed 24164355

  • Graciani A, Rodriguez-Artalejo F, Navarro-Vidal B, Banegas JR. Glycemic control using individualized targets among diabetic patients in Spain: a population-based study. Rev Esp Cardiol (Engl Ed). 2014 Feb;67(2):151-3. doi: 10.1016/j.rec.2013.07.018. Epub 2013 Dec 4. No abstract available.

    PubMed 24795130

  • Guallar-Castillon P, Perez RF, Lopez Garcia E, Leon-Munoz LM, Aguilera MT, Graciani A, Gutierrez-Fisac JL, Banegas JR, Rodriguez-Artalejo F. Magnitude and management of metabolic syndrome in Spain in 2008-2010: the ENRICA study. Rev Esp Cardiol (Engl Ed). 2014 May;67(5):367-73. doi: 10.1016/j.rec.2013.08.014. Epub 2014 Jan 14.

    PubMed 24774729

  • Leon-Munoz LM, Galan I, Donado-Campos J, Sanchez-Alonso F, Lopez-Garcia E, Valencia-Martin JL, Guallar-Castillon P, Rodriguez-Artalejo F. Patterns of alcohol consumption in the older population of Spain, 2008-2010. J Acad Nutr Diet. 2015 Feb;115(2):213-224. doi: 10.1016/j.jand.2014.08.017. Epub 2014 Oct 5.

    PubMed 25288520

  • Blanco-Rojo R, Sandoval-Insausti H, Lopez-Garcia E, Graciani A, Ordovas JM, Banegas JR, Rodriguez-Artalejo F, Guallar-Castillon P. Consumption of Ultra-Processed Foods and Mortality: A National Prospective Cohort in Spain. Mayo Clin Proc. 2019 Nov;94(11):2178-2188. doi: 10.1016/j.mayocp.2019.03.035. Epub 2019 Oct 14.

    PubMed 31623843

  • Laclaustra M, Rodriguez-Artalejo F, Guallar-Castillon P, Banegas JR, Graciani A, Garcia-Esquinas E, Lopez-Garcia E. The inflammatory potential of diet is related to incident frailty and slow walking in older adults. Clin Nutr. 2020 Jan;39(1):185-191. doi: 10.1016/j.clnu.2019.01.013. Epub 2019 Jan 24.

    PubMed 30737049

Questions about this trial

What is this clinical trial studying?

An observational study of Cardiovascular Disease, run by Universidad Autonoma de Madrid at 1 site 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 2 inclusion and 1 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 6 May 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site 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?

Cardiovascular Risk Factors Control (time frame: 2 years). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01133093, which also lists 16 linked publications.

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 6 May 2016.

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