Cardiovascular and Renal Risk in Spain

Cardiovascular Disease Clinical Trial

— IBERICAN  

Official title:

Identificación de la poBlación Española de RIesgo CArdiovascular y reNal

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02261441
• Other study ID #: IBERICAN
• Status: Recruiting
• Phase: N/A
• First received: September 27, 2014
• Last updated: April 30, 2017
• Start date: February 2014
• Est. completion date: February 2019

Study information

• Verified date: April 2017
• Source: La Sociedad Española de Médicos de Atención Primaria
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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 As a result, treatments of patients will be prescribed, modified or withdrawn according only to physicians´ judgment.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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 15000
• Est. completion date: February 2019
• Est. primary completion date: February 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

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.

Related Conditions & MeSH terms

• Cardiovascular Disease
• Cardiovascular Diseases

Intervention

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.

Locations

Country	Name	City	State
Spain	Goya, 25	Madrid

Sponsors (1)

Lead Sponsor	Collaborator
La Sociedad Española de Médicos de Atención Primaria

Country where clinical trial is conducted

Spain, 

References & Publications (16)

Bastuji-Garin S, Deverly A, Moyse D, Castaigne A, Mancia G, de Leeuw PW, Ruilope LM, Rosenthal T, Chatellier G; Intervention as a Goal in Hypertension Treatment Study Group.. The Framingham prediction rule is not valid in a European population of treated — View Citation

Burgmaier M, Heinrich C, Marx N. Cardiovascular effects of GLP-1 and GLP-1-based therapies: implications for the cardiovascular continuum in diabetes? Diabet Med. 2013 Mar;30(3):289-99. doi: 10.1111/j.1464-5491.2012.03746.x. Review. — View Citation

Cavelaars AE, Kunst AE, Geurts JJ, Crialesi R, Grötvedt L, Helmert U, Lahelma E, Lundberg O, Matheson J, Mielck A, Mizrahi A, Mizrahi A, Rasmussen NK, Regidor E, Spuhler T, Mackenbach JP. Differences in self reported morbidity by educational level: a comp — View Citation

Daniels SR. Prevention of atherosclerotic cardiovascular disease: what is the best approach and how early should we start? J Am Coll Cardiol. 2014 Jul 1;63(25 Pt A):2786-8. doi: 10.1016/j.jacc.2014.01.082. Epub 2014 May 7. Review. — View Citation

Félix-Redondo FJ, Fernández-Bergés D, Grau M, Baena-Diez JM, Mostaza JM, Vila J. Prevalence and clinical characteristics of peripheral arterial disease in the study population Hermex. Rev Esp Cardiol (Engl Ed). 2012 Aug;65(8):726-33. Epub 2012 Jun 22. Eng — View Citation

Fiol M, Cabadés A, Sala J, Marrugat J, Elosua R, Vega G, José Tormo Díaz M, Segura A, Aldasoro E, Moreno-Iribas C, Muñiz J, Hurtado de Saracho I, García J. [Variability in the in-hospital management of acute myocardial infarction in Spain. IBERICA Study ( — View Citation

Gispert Magarolas R, Barés Marcano MA, Freitas Ramírez A, Torné Farré M, Puigdefàbregas Serra A, Alberquilla A, Albert X, Luis Alfonso J, Caminal J, Fernández-Cuenca R, García F, Gervas J, Librero J, Martos C, Medrano MJ, Ruiz M. [Health system interventi — View Citation

González-Juanatey JR, Cordero A. Benefits of delapril in hypertensive patients along the cardiovascular continuum. Expert Rev Cardiovasc Ther. 2013 Mar;11(3):271-81. doi: 10.1586/erc.12.188. Review. — View Citation

Kavouras SA, Panagiotakos DB, Pitsavos C, Chrysohoou C, Arnaoutis G, Skoumas Y, Stefanadis C. Physical Activity and Adherence to Mediterranean Diet Increase Total Antioxidant Capacity: The ATTICA Study. Cardiol Res Pract. 2010 Oct 20;2011:248626. doi: 10. — View Citation

Marrugat J, Elosua R, Martí H. [Epidemiology of ischaemic heart disease in Spain: estimation of the number of cases and trends from 1997 to 2005]. Rev Esp Cardiol. 2002 Apr;55(4):337-46. Spanish. — View Citation

Marrugat J, Sanz G, Masiá R, Valle V, Molina L, Cardona M, Sala J, Serés L, Szescielinski L, Albert X, Lupón J, Alonso J. Six-month outcome in patients with myocardial infarction initially admitted to tertiary and nontertiary hospitals. RESCATE Investigat — View Citation

Marrugat J, Subirana I, Comín E, Cabezas C, Vila J, Elosua R, Nam BH, Ramos R, Sala J, Solanas P, Cordón F, Gené-Badia J, D'Agostino RB; VERIFICA Investigators.. Validity of an adaptation of the Framingham cardiovascular risk function: the VERIFICA Study. — View Citation

Mazón-Ramos P. [Cardiovascular risk in the 21st century: identifying risk in primary prevention. Controlling risk in secondary prevention]. Rev Esp Cardiol (Engl Ed). 2012 Jul;65 Suppl 2:3-9. Review. Spanish. — View Citation

Panagiotakos DB, Pitsavos C, Stefanadis C. Dietary patterns: a Mediterranean diet score and its relation to clinical and biological markers of cardiovascular disease risk. Nutr Metab Cardiovasc Dis. 2006 Dec;16(8):559-68. Epub 2006 Feb 9. — View Citation

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, V — View Citation

Persic V. Obesity in the cardiovascular continuum. Curr Clin Pharmacol. 2013 May;8(2):159-63. — View Citation

* Note: There are 16 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cardiovascular event	Development of cardiovascular events.	5 years
Primary	Cardiovascular risk factors	Development of cardiovascular risk factors.	5 years