NCT02261441

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
15,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Feb 2014

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2014

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

September 27, 2014

Completed
13 days until next milestone

First Posted

Study publicly available on registry

October 10, 2014

Completed
4.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2019

Completed
Last Updated

May 2, 2017

Status Verified

April 1, 2017

Enrollment Period

5 years

First QC Date

September 27, 2014

Last Update Submit

April 30, 2017

Conditions

Keywords

Cardiovascular diseaseHypertensionDiabetesSmokingHypercholesterolemiaCardiovascular risk factor

Outcome Measures

Primary Outcomes (2)

  • Cardiovascular event

    Development of cardiovascular events.

    5 years

  • Cardiovascular risk factors

    Development of cardiovascular risk factors.

    5 years

Study Arms (1)

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

Interventions

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.

Group 1

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Subjects irrespective of the presence of risk factors or cardiovascular disease throughout Spain

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Goya, 25

Madrid, 28001, Spain

RECRUITING

Related Publications (17)

  • 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.

  • 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.

  • 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.

  • 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.

  • 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.

  • 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.

  • 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.

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

  • 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.

  • 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.

  • 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.

  • 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.

  • 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.

  • 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.

  • 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.

  • 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.

  • 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.

MeSH Terms

Conditions

Cardiovascular DiseasesHypertensionDiabetes MellitusSmokingHypercholesterolemia

Condition Hierarchy (Ancestors)

Vascular DiseasesGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesBehaviorHyperlipidemiasDyslipidemiasLipid Metabolism Disorders

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD, PhD

Study Record Dates

First Submitted

September 27, 2014

First Posted

October 10, 2014

Study Start

February 1, 2014

Primary Completion

February 1, 2019

Study Completion

February 1, 2019

Last Updated

May 2, 2017

Record last verified: 2017-04

Data Sharing

IPD Sharing
Will not share

Locations