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Cardiovascular and Renal Risk in Spain (IBERICAN)

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ClinicalTrials.gov Identifier: NCT02261441
Recruitment Status : Unknown
Verified April 2017 by Carlos Escobar, La Sociedad Española de Médicos de Atención Primaria.
Recruitment status was:  Recruiting
First Posted : October 10, 2014
Last Update Posted : May 2, 2017
Sponsor:
Information provided by (Responsible Party):
Carlos Escobar, La Sociedad Española de Médicos de Atención Primaria

Brief Summary:

IBERICAN is a multicenter, longitudinal and observational population-based study of patients daily attended in Primary Care setting in Spain.

This study is aimed to determine the prevalence and incidence of cardiovascular risk factors in adult population in Spain.

Patients will be followed-up for a minimum period of 5 years, every 6 months or a lesser period when clinically required.

It has been estimated that a total of 15,000 individuals will be included.


Condition or disease Intervention/treatment
Cardiovascular Disease Other: Observational and noninterventional study

Detailed Description:

IBERICAN (Identificación de la poBlación Española de RIesgo CArdio Vascular y reNal) is a multicenter, longitudinal and observational population-based study of patients daily attended in Primary Care setting in Spain.

The aims of IBERICAN are to determine the prevalence and incidence of cardiovascular risk factors in adult population in Spain. Moreover, the development of cardiovascular outcomes, and risk factors control rates will be also analyzed.

In IBERICAN, subjects irrespective of the presence of risk factors or cardiovascular disease throughout Spain will be included.

No specific recommendations will be provide to physicians about treatments. As a result, treatments of patients will be prescribed, modified or withdrawn according only to physicians´ judgment. The study has been approved by the ethic committee of Hospital Carlos III, Madrid on February 2013. Before inclusion, every patient will provide a written informed consent.

Patients will be followed-up for a minimum period of 5 years, every 6 months or a lesser period when clinically required. Excepting a blood analysis in the previous 6 months before the inclusion, no other specific diagnostic tool or technique will be required for being included in the study. All blood and urine analysis or other techniques will be performed according to clinical practice during the follow-up.

It has been estimated that a total of 15,000 individuals will be included.

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Study Type : Observational
Estimated Enrollment : 15000 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Identificación de la poBlación Española de RIesgo CArdiovascular y reNal
Study Start Date : February 2014
Estimated Primary Completion Date : February 2019
Estimated Study Completion Date : February 2019

Group/Cohort Intervention/treatment
Group 1
Subjects irrespective of the presence of risk factors or cardiovascular disease throughout Spain will be included. This is an observational and non-interventional study
Other: Observational and noninterventional study
No specific recommendations will be provide to physicians about treatments. As a result, treatments of patients will be prescribed, modified or withdrawn according only to physicians´ judgment.




Primary Outcome Measures :
  1. Cardiovascular event [ Time Frame: 5 years ]
    Development of cardiovascular events.

  2. Cardiovascular risk factors [ Time Frame: 5 years ]
    Development of cardiovascular risk factors.



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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
Subjects irrespective of the presence of risk factors or cardiovascular disease throughout Spain
Criteria

Inclusion Criteria:

  • National Health Care System user.
  • Resident at Spain in the last 5 years.
  • Attended by investigator in Primary Care setting.

Exclusion Criteria:

  • Change of regular residence to other city or country in the following 6 months.
  • Life expectancy less than 5 years.
  • Difficult to follow-up.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02261441


Locations
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Spain
Goya, 25 Recruiting
Madrid, Spain, 28001
Contact: Carlos Escobar, MD, PhD       escobar_cervantes_carlos@hotmail.com   
Sponsors and Collaborators
La Sociedad Española de Médicos de Atención Primaria
Publications of Results:
Perk J, De Backer G, Gohlke H, Graham I, Reiner Z, Verschuren M, Albus C, Benlian P, Boysen G, Cifkova R, Deaton C, Ebrahim S, Fisher M, Germano G, Hobbs R, Hoes A, Karadeniz S, Mezzani A, Prescott E, Ryden L, Scherer M, Syvänne M, Scholte op Reimer WJ, Vrints C, Wood D, Zamorano JL, Zannad F; European Association for Cardiovascular Prevention & Rehabilitation (EACPR); ESC Committee for Practice Guidelines (CPG). European Guidelines on cardiovascular disease prevention in clinical practice (version 2012). The Fifth Joint Task Force of the European Society of Cardiology and Other Societies on Cardiovascular Disease Prevention in Clinical Practice (constituted by representatives of nine societies and by invited experts). Eur Heart J. 2012 Jul;33(13):1635-701. doi: 10.1093/eurheartj/ehs092. Epub 2012 May 3. Erratum in: Eur Heart J. 2012 Sep;33(17):2126.

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Responsible Party: Carlos Escobar, MD, PhD, La Sociedad Española de Médicos de Atención Primaria
ClinicalTrials.gov Identifier: NCT02261441    
Other Study ID Numbers: IBERICAN
First Posted: October 10, 2014    Key Record Dates
Last Update Posted: May 2, 2017
Last Verified: April 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Carlos Escobar, La Sociedad Española de Médicos de Atención Primaria:
Cardiovascular disease
Hypertension
Diabetes
Smoking
Hypercholesterolemia
Cardiovascular risk factor
Additional relevant MeSH terms:
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Cardiovascular Diseases