Cardiovascular DiseaseIBERICANNCT02261441
Cardiovascular and Renal Risk in Spain
An observational study of Cardiovascular Disease, run by La Sociedad Española de Médicos de Atención Primaria at 1 site in Spain.
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. Read more about this study
- Who is it for?
- Ages 18 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- Cardiovascular Disease
- What is being tested?
- Observational and noninterventional study
- How many people
- 15,000 participants
- Where
- 1 siteSpain
- Study dates
- Feb 2014to Feb 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Subjects irrespective of the presence of risk factors or cardiovascular disease throughout Spain
Who may be able to join
- National Health Care System user.
- Resident at Spain in the last 5 years.
- Attended by investigator in Primary Care setting.
Who cannot join
- Change of regular residence to other city or country in the following 6 months.
- Life expectancy less than 5 years.
- Difficult to follow-up.
Trial locations and contacts
1 site in 1 country.
Spain1 site, 1 recruiting
- Recruiting
Goya, 25
Madrid, 28001
Carlos Escobar, MD, PhD, escobar_cervantes_carlos@hotmail.com
About this study
Official title: Identificación de la poBlación Española de RIesgo CArdiovascular y reNal
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.
Read the 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.
- Conditions
- Cardiovascular Disease
- Being tested
- Observational and noninterventional study
- Keywords
- Cardiovascular disease, Hypertension, Diabetes, Smoking, Hypercholesterolemia, Cardiovascular risk factor
- Medical subject headings
- Cardiovascular Diseases, Hypertension, Diabetes Mellitus, Smoking, Hypercholesterolemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Observational and noninterventional studyOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Other: Observational and noninterventional study |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cardiovascular event
Development of cardiovascular events.
Measured: 5 years
Cardiovascular risk factors
Development of cardiovascular risk factors.
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Oct 2014 (estimated)
- Study startFeb 2014
- Primary completionFeb 2019 (estimated)
- Study completionFeb 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (18)Papers the sponsor has linked to this study.
- Other trials for Cardiovascular DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 15,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- La Sociedad Española de Médicos de Atención Primaria
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Carlos Escobar, La Sociedad Española de Médicos de Atención Primaria
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02261441
- Sponsor's protocol ID
- IBERICAN
- Acronym
- IBERICAN
- Status last verified
- Apr 2017
- First submitted
- 27 Sep 2014
- Last updated
- 2 May 2017
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 9616407Marrugat 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.
PubMed 11975899Fiol 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.
PubMed 11282049Marrugat 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.
PubMed 9350913Gispert 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.
PubMed 16719023Felix-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.
PubMed 22727799Daniels 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.
PubMed 24814499Persic V. Obesity in the cardiovascular continuum. Curr Clin Pharmacol. 2013 May;8(2):159-63. doi: 10.2174/1574884711308020008.
PubMed 22950957Burgmaier 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.
PubMed 22804451Gonzalez-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.
PubMed 23469905Perk 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.
PubMed 22555213Bastuji-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.
PubMed 12359975Marrugat 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.
PubMed 17183014Mazon-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.
PubMed 22921168Kavouras 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.
PubMed 20981278
Study at a glance
From the registry record, last updated by the sponsor on 2 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Identificación de la poBlación Española de RIesgo CArdiovascular y reNal
- ClinicalTrials.gov ID
- NCT02261441
- Acronym / sponsor ID
- IBERICAN / IBERICAN
- Conditions
- Cardiovascular Disease
- Keywords
- Cardiovascular disease, Hypertension, Diabetes, Smoking, Hypercholesterolemia, Cardiovascular risk factor
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 15,000 participants (estimated)
- Lead sponsor
- La Sociedad Española de Médicos de Atención PrimariaUniversity, hospital or other
- Study start
- Feb 2014
- Primary completion
- Feb 2019 (estimated)
- Study completion
- Feb 2019 (estimated)
- First posted
- 10 Oct 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Group 1 | – | Other: Observational and noninterventional studySubjects irrespective of the presence of risk factors or cardiovascular disease throughout Spain will be included. This is an observational and non-interventional study |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Subjects irrespective of the presence of risk factors or cardiovascular disease throughout Spain
Key inclusion criteria (3 listed)
- National Health Care System user.
- Resident at Spain in the last 5 years.
- Attended by investigator in Primary Care setting.
Key exclusion criteria (3 listed)
- Change of regular residence to other city or country in the following 6 months.
- Life expectancy less than 5 years.
- Difficult to follow-up.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Observational and noninterventional studyNo 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. | Other | Group 1 |
Primary outcome
Cardiovascular event
Time frame: 5 years
Development of cardiovascular events.
Cardiovascular risk factors
Time frame: 5 years
Development of cardiovascular risk factors.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 May 2017.
- Results publication: PubMed 9616407Cavelaars 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.
- Results publication: PubMed 11975899Marrugat 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.
- Results publication: PubMed 11282049Fiol 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.
- Results publication: PubMed 9350913Marrugat 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.
- Results publication: PubMed 16719023Gispert 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.
- Results publication: PubMed 22727799Felix-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.
- Results publication: PubMed 24814499Daniels 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.
- Results publication: PubMed 22950957Persic V. Obesity in the cardiovascular continuum. Curr Clin Pharmacol. 2013 May;8(2):159-63. doi: 10.2174/1574884711308020008.
- Results publication: PubMed 22804451Burgmaier 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.
- Results publication: PubMed 23469905Gonzalez-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.
- Results publication: PubMed 22555213Perk 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.
- Results publication: PubMed 12359975Bastuji-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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cardiovascular Disease, run by La Sociedad Española de Médicos de Atención Primaria at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 2 May 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cardiovascular event (time frame: 5 years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02261441, which also lists 18 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 May 2017; AzTrials last refreshed its copy on 6 Nov 2026.