Clinical trial NCT02261441: Cardiovascular and Renal Risk in Spain
Official title: Identificación de la poBlación Española de RIesgo CArdiovascular y reNal
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Cardiovascular Disease
Keywords: Cardiovascular disease
Hypertension
Diabetes
Smoking
Hypercholesterolemia
Cardiovascular risk factor
Lead sponsor: La Sociedad Española de Médicos de Atención Primaria
Sponsor class: OTHER
First posted: 2014-10-10
Enrollment: 15000
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Subjects irrespective of the presence of risk factors or cardiovascular disease throughout Spain

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.

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 As a result, treatments of patients will be prescribed, modified or withdrawn according only to physicians´ judgment.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.

Eligibility 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.

Primary outcomes:
measure: Cardiovascular event
timeFrame: 5 years
measure: Cardiovascular risk factors
timeFrame: 5 years
Secondary outcomes:
Other outcomes:
Locations:
city: Madrid
country: Spain
facility: Goya, 25
Study officials:
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