Structural Heart AbnormalitySALMANTICORNCT03429452
The SALMANTICOR Study
An observational study of Structural Heart Abnormality, run by AORTICA Group at 1 site in Spain.
Trial summary
The SALMANTICOR study will obtain data on the prevalence and incidence of structural heart disease in a population setting. A cross-section survey of randomly selected residents of Salamanca (Spain) will be performed. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Structural Heart Abnormality
- How many people
- 2,057 participants
- Where
- 1 siteSpain
- Study dates
- 15 Oct 2015to May 2019
- How long will I take part?
- 5 Years
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: 2400 individuals, stratifies by place of residence (rural and urban), by age and by sex, in a Spanish community: Salamanca
Who may be able to join
- Any individual willing to participate
Who cannot join
- Death people not identified in the community records
- Not able to attend the visit
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Population-based Study to Identify Structural Heart Disease Abnormalities in a Spanish Community: Salamanca. The SALMANTICOR Study
The SALMANTICOR study will obtain data on the prevalence and incidence of structural heart disease in a population setting. A cross-section survey of randomly selected residents of Salamanca (Spain) will be performed. A total of approximately 2400 individuals, stratifies by place of residence (rural and urban) and by age and sex will be studied. The variables to analyzed will be obtained from the clinical history, different surveys including social status, Mediterranean diet, functional capacity, electrocardiogram, echocardiogram and biochemical and genetic analysis. Surviving participants are expected to return for a 5 and 10-year follow-up visit.
Read the detailed description
The objectives of this study are: to obtain data on the prevalence and incidence of structural heart disease in a population setting; to show the spatial distribution different patterns of structural heart disease through the spectrum of age and sex and between urban and rural; and to generate new hypotheses which might serve to healthcare research and to political commitment to obtain resources and support effective public health program implementation.
The SALMANTICOR study is a cross-sectional descriptive population-based study of the prevalence of structural heart disease and their risk factors that will enroll a total of 2400 individuals, stratifies by place of residence (rural and urban), by age and by sex, in a Spanish community: Salamanca. Cohort participants will undergo a basal examination visit between 2015 and 2018. Surviving participants are expected to return for a 5 and 10-year follow-up visit. Institutional review committee approval was obtained and all participants will provide informed consent. The SALMANTICOR study is designed to provide echocardiographic parameters characterizing cardiac structure and function in all individuals. Medical history, surveys completion, and examinations will be obtained at the subject´s primary care referral center and will be analyzed and interpreted centrally at University Hospital of Salamanca. A complete medical history, physical examination and the surveys completion checkout will be performed by a cardiologist in a separate office to where examinations and blood sample extraction will be performed. Echocardiographic measures will be initially performed. Participant blood pressure and VASERA measures will be taken within 30 minutes of starting the echocardiographic exam and after the subject will be resting for 10 minutes. ECG will be performed after VASERA to finalize with the blood sample extraction. A magnetic resonance substudy and and a details analyses in diabetic individuals will also performed. SALMANTICOR participants will undergo surveillance for cardiovascular events, including heart failure, incident coronary heart disease, and all-cause mortality.
- Conditions
- Structural Heart Abnormality
- Keywords
- structural heart abnormality, spatial method, echocardiography, electrocardiogram, mediterranean diet, exercise, social status, rural
- Medical subject headings
- Motor Activity
What is being measured
The primary outcome is the main question the study is designed to answer.
prevalence of structural heart disease in a population setting
Structural heart disease refers to any of the following heat abnormalities including congenital heart disease, cardiomyoptathies, valvular heart disease, pericardial diseases and rhythm or conduction disorders
Measured: through study completion, an average of 3 years
incidence of structural heart disease in a population setting
Structural heart disease refers to any of the following heat abnormalities including congenital heart disease, cardiomyoptathies, valvular heart disease, pericardial diseases and rhythm or conduction disorders
Measured: 5 years follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Feb 2018
- Study start15 Oct 2015
- Primary completion25 May 2018
- Study completionMay 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Structural Heart AbnormalityStudies 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
- Ecologic or community
- Time perspective
- Prospective
- Enrolment
- 2,057 participants (actual)
- Target duration
- 5 Years
Sponsor and investigators
- Lead sponsor
- AORTICA Group
- Sponsor type
- University, hospital or other
- Collaborators
- University of Salamanca
- Responsible party
- Principal investigator, Pedro L Sanchez, Salamanca University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03429452
- Sponsor's protocol ID
- PI14/00695
- Acronym
- SALMANTICOR
- Status last verified
- Jun 2019
- First submitted
- 10 Jan 2018
- Last updated
- 10 Jun 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Publications
Melero-Alegria JI, Cascon M, Romero A, Vara PP, Barreiro-Perez M, Vicente-Palacios V, Perez-Escanilla F, Hernandez-Hernandez J, Garde B, Cascon S, Martin-Garcia A, Diaz-Pelaez E, de Dios JM, Uribarri A, Jimenez-Candil J, Cruz-Gonzalez I, Blazquez B, Hernandez JM, Sanchez-Pablo C, Santolino I, Ledesma MC, Muriel P, Dorado-Diaz PI, Sanchez PL. SALMANTICOR study. Rationale and design of a population-based study to identify structural heart disease abnormalities: a spatial and machine learning analysis. BMJ Open. 2019 Feb 13;9(2):e024605. doi: 10.1136/bmjopen-2018-024605.
PubMed 30765403
Study at a glance
From the registry record, last updated by the sponsor on 10 Jun 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Population-based Study to Identify Structural Heart Disease Abnormalities in a Spanish Community: Salamanca. The SALMANTICOR Study
- ClinicalTrials.gov ID
- NCT03429452
- Acronym / sponsor ID
- SALMANTICOR / PI14/00695
- Conditions
- Structural Heart Abnormality
- Keywords
- structural heart abnormality, spatial method, echocardiography, electrocardiogram, mediterranean diet, exercise, social status, rural
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 2,057 participants (actual)
- Lead sponsor
- AORTICA GroupUniversity, hospital or other
- Collaborators
- University of Salamanca
- Study start
- 15 Oct 2015 (actual)
- Primary completion
- 25 May 2018 (actual)
- Study completion
- May 2019 (actual)
- First posted
- 12 Feb 2018 (actual)
- 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.
The SALMANTICOR study will obtain data on the prevalence and incidence of structural heart disease in a population setting. A cross-section survey of randomly selected residents of Salamanca (Spain) will be performed. A total of approximately 2400 individuals, stratifies by place of residence (rural and urban) and by age and sex will be studied. The variables to analyzed will be obtained from the clinical history, different surveys including social status, Mediterranean diet, functional capacity, electrocardiogram, echocardiogram and biochemical and genetic analysis. Surviving participants are expected to return for a 5 and 10-year follow-up visit.
Detailed description
The objectives of this study are: to obtain data on the prevalence and incidence of structural heart disease in a population setting; to show the spatial distribution different patterns of structural heart disease through the spectrum of age and sex and between urban and rural; and to generate new hypotheses which might serve to healthcare research and to political commitment to obtain resources and support effective public health program implementation.
The SALMANTICOR study is a cross-sectional descriptive population-based study of the prevalence of structural heart disease and their risk factors that will enroll a total of 2400 individuals, stratifies by place of residence (rural and urban), by age and by sex, in a Spanish community: Salamanca. Cohort participants will undergo a basal examination visit between 2015 and 2018. Surviving participants are expected to return for a 5 and 10-year follow-up visit. Institutional review committee approval was obtained and all participants will provide informed consent. The SALMANTICOR study is designed to provide echocardiographic parameters characterizing cardiac structure and function in all individuals. Medical history, surveys completion, and examinations will be obtained at the subject´s primary care referral center and will be analyzed and interpreted centrally at University Hospital of Salamanca. A complete medical history, physical examination and the surveys completion checkout will be performed by a cardiologist in a separate office to where examinations and blood sample extraction will be performed. Echocardiographic measures will be initially performed. Participant blood pressure and VASERA measures will be taken within 30 minutes of starting the echocardiographic exam and after the subject will be resting for 10 minutes. ECG will be performed after VASERA to finalize with the blood sample extraction. A magnetic resonance substudy and and a details analyses in diabetic individuals will also performed. SALMANTICOR participants will undergo surveillance for cardiovascular events, including heart failure, incident coronary heart disease, and all-cause mortality.
Study design
- Observational model
- Ecologic or community
- Time perspective
- Prospective
- Target follow-up
- 5 Years
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 2400 individuals, stratifies by place of residence (rural and urban), by age and by sex, in a Spanish community: Salamanca
Key inclusion criteria (1 listed)
- Any individual willing to participate
Key exclusion criteria (2 listed)
- Death people not identified in the community records
- Not able to attend the visit
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
prevalence of structural heart disease in a population setting
Time frame: through study completion, an average of 3 years
Structural heart disease refers to any of the following heat abnormalities including congenital heart disease, cardiomyoptathies, valvular heart disease, pericardial diseases and rhythm or conduction disorders
incidence of structural heart disease in a population setting
Time frame: 5 years follow-up
Structural heart disease refers to any of the following heat abnormalities including congenital heart disease, cardiomyoptathies, valvular heart disease, pericardial diseases and rhythm or conduction disorders
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jun 2019.
- Results publication: PubMed 30765403Melero-Alegria JI, Cascon M, Romero A, Vara PP, Barreiro-Perez M, Vicente-Palacios V, Perez-Escanilla F, Hernandez-Hernandez J, Garde B, Cascon S, Martin-Garcia A, Diaz-Pelaez E, de Dios JM, Uribarri A, Jimenez-Candil J, Cruz-Gonzalez I, Blazquez B, Hernandez JM, Sanchez-Pablo C, Santolino I, Ledesma MC, Muriel P, Dorado-Diaz PI, Sanchez PL. SALMANTICOR study. Rationale and design of a population-based study to identify structural heart disease abnormalities: a spatial and machine learning analysis. BMJ Open. 2019 Feb 13;9(2):e024605. doi: 10.1136/bmjopen-2018-024605.
- Individual participant dataSharing planned: Yes
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Structural Heart Abnormality, run by AORTICA Group 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 1 inclusion and 2 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: finished, as of the sponsor's last update on 10 Jun 2019. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
prevalence of structural heart disease in a population setting (time frame: through study completion, an average of 3 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 NCT03429452, which also lists 1 linked publication.
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 10 Jun 2019.