Cardiovascular and Renal Risk in Spain

NCT ID: NCT02261441

Last Updated: 2017-05-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Total Enrollment

15000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2014-02-28

Study Completion Date

2019-02-28

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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 As a result, treatments of patients will be prescribed, modified or withdrawn according only to physicians´ judgment.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

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Cardiovascular Disease

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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

Observational and noninterventional study

Intervention Type OTHER

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.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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.

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

La Sociedad Española de Médicos de Atención Primaria

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Carlos Escobar

MD, PhD

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Goya, 25

Madrid, , Spain

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

Spain

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Carlos Escobar, MD, PhD

Role: primary

References

Explore related publications, articles, or registry entries linked to this study.

Cavelaars AE, Kunst AE, Geurts JJ, Crialesi R, Grotvedt 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 comparison of 11 western European countries. J Epidemiol Community Health. 1998 Apr;52(4):219-27. doi: 10.1136/jech.52.4.219.

Reference Type RESULT
PMID: 9616407 (View on PubMed)

Marrugat J, Elosua R, Marti 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. doi: 10.1016/s0300-8932(02)76611-6. Spanish.

Reference Type RESULT
PMID: 11975899 (View on PubMed)

Fiol M, Cabades A, Sala J, Marrugat J, Elosua R, Vega G, Jose Tormo Diaz M, Segura A, Aldasoro E, Moreno-Iribas C, Muniz J, Hurtado de Saracho I, Garcia J. [Variability in the in-hospital management of acute myocardial infarction in Spain. IBERICA Study (Investigacion, Busqueda Especifica y Registro de Isquemia Coronaria Aguda)]. Rev Esp Cardiol. 2001 Apr;54(4):443-52. doi: 10.1016/s0300-8932(01)76332-4. Spanish.

Reference Type RESULT
PMID: 11282049 (View on PubMed)

Marrugat J, Sanz G, Masia R, Valle V, Molina L, Cardona M, Sala J, Seres L, Szescielinski L, Albert X, Lupon J, Alonso J. Six-month outcome in patients with myocardial infarction initially admitted to tertiary and nontertiary hospitals. RESCATE Investigators. Recursos Empleados en el Sindrome Coronario Agudo y Tiempos de Espera. J Am Coll Cardiol. 1997 Nov 1;30(5):1187-92. doi: 10.1016/s0735-1097(97)00312-4.

Reference Type RESULT
PMID: 9350913 (View on PubMed)

Gispert Magarolas R, Bares Marcano MA, Freitas Ramirez A, Torne Farre M, Puigdefabregas Serra A, Alberquilla A, Albert X, Luis Alfonso J, Caminal J, Fernandez-Cuenca R, Garcia F, Gervas J, Librero J, Martos C, Medrano MJ, Ruiz M. [Health system interventions assessment in Spain: an approach through the analysis of the time trends and the geographical variability of avoidable mortality between 1986 -2001]. Rev Esp Salud Publica. 2006 Mar-Apr;80(2):139-55. doi: 10.1590/s1135-57272006000200004. Spanish.

Reference Type RESULT
PMID: 16719023 (View on PubMed)

Felix-Redondo FJ, Fernandez-Berges 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. doi: 10.1016/j.recesp.2012.03.008. Epub 2012 Jun 22. English, Spanish.

Reference Type RESULT
PMID: 22727799 (View on PubMed)

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. No abstract available.

Reference Type RESULT
PMID: 24814499 (View on PubMed)

Persic V. Obesity in the cardiovascular continuum. Curr Clin Pharmacol. 2013 May;8(2):159-63. doi: 10.2174/1574884711308020008.

Reference Type RESULT
PMID: 22950957 (View on PubMed)

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.

Reference Type RESULT
PMID: 22804451 (View on PubMed)

Gonzalez-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.

Reference Type RESULT
PMID: 23469905 (View on PubMed)

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, Syvanne 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. No abstract available.

Reference Type RESULT
PMID: 22555213 (View on PubMed)

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 hypertensive patients. J Hypertens. 2002 Oct;20(10):1973-80. doi: 10.1097/00004872-200210000-00016.

Reference Type RESULT
PMID: 12359975 (View on PubMed)

Marrugat J, Subirana I, Comin E, Cabezas C, Vila J, Elosua R, Nam BH, Ramos R, Sala J, Solanas P, Cordon F, Gene-Badia J, D'Agostino RB; VERIFICA Investigators. Validity of an adaptation of the Framingham cardiovascular risk function: the VERIFICA Study. J Epidemiol Community Health. 2007 Jan;61(1):40-7. doi: 10.1136/jech.2005.038505.

Reference Type RESULT
PMID: 17183014 (View on PubMed)

Mazon-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. doi: 10.1016/j.recesp.2012.07.004. Spanish.

Reference Type RESULT
PMID: 22921168 (View on PubMed)

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: 10.4061/2011/248626.

Reference Type RESULT
PMID: 20981278 (View on PubMed)

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. doi: 10.1016/j.numecd.2005.08.006. Epub 2006 Feb 9.

Reference Type RESULT
PMID: 17126772 (View on PubMed)

Cinza-Sanjurjo S, Prieto-Diaz MA, Pallares-Carratala V, Mico-Perez RM, Velilla-Zancada S, Barquilla-Garcia A, Ginel-Mendoza L, Segura-Fragoso A, Martin-Sanchez V, Polo-Garcia J. Characteristics of the phenotypes in prevalent and incident cases of heart failure in primary care: IBERICAN study. BMC Prim Care. 2024 Jul 25;25(1):271. doi: 10.1186/s12875-024-02506-1.

Reference Type DERIVED
PMID: 39054420 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

IBERICAN

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.