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The SALMANTICOR Study (SALMANTICOR)

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ClinicalTrials.gov Identifier: NCT03429452
Recruitment Status : Recruiting
First Posted : February 12, 2018
Last Update Posted : February 12, 2018
Sponsor:
Collaborator:
University of Salamanca
Information provided by (Responsible Party):
Pedro L Sanchez, Salamanca University Hospital

Brief 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. 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.

Condition or disease
Structural Heart Abnormality

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 Type : Observational [Patient Registry]
Estimated Enrollment : 2400 participants
Observational Model: Ecologic or Community
Time Perspective: Prospective
Target Follow-Up Duration: 5 Years
Official Title: Population-based Study to Identify Structural Heart Disease Abnormalities in a Spanish Community: Salamanca. The SALMANTICOR Study
Actual Study Start Date : November 23, 2015
Estimated Primary Completion Date : April 2018
Estimated Study Completion Date : August 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Diseases




Primary Outcome Measures :
  1. 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

  2. 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


Biospecimen Retention:   Samples With DNA
Biomarkers and DNA samples will be stored in a biobank


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
2400 individuals, stratifies by place of residence (rural and urban), by age and by sex, in a Spanish community: Salamanca
Criteria

Inclusion Criteria:

  • Any individual willing to participate

Exclusion Criteria:

  • Death people not identified in the community records
  • Not able to attend the visit

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03429452


Contacts
Contact: Pedro L Sanchez, MD, PhD 34923291100 ext 55356 pedrolsanchez@secardiologia.es

Locations
Spain
Hospital Universitario de Salamanca Recruiting
Salamanca, Spain, 37002
Contact: Pedro L Sanchez, MD, PhD    34-637971999    pedrolsanchez@secardiologia.es   
Contact: Manuel Cascón, MD, PhD         
Sub-Investigator: Jose Ignacio Alegria         
Principal Investigator: Pedro L Sanchez, MD, PhD         
Sponsors and Collaborators
AORTICA Group
University of Salamanca

Responsible Party: Pedro L Sanchez, Head of Cardiology, PhD, MD, Salamanca University Hospital
ClinicalTrials.gov Identifier: NCT03429452     History of Changes
Other Study ID Numbers: PI14/00695
First Posted: February 12, 2018    Key Record Dates
Last Update Posted: February 12, 2018
Last Verified: February 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
URL: http://

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Pedro L Sanchez, Salamanca University Hospital:
structural heart abnormality
spatial method
echocardiography
electrocardiogram
mediterranean diet
exercise
social status
rural

Additional relevant MeSH terms:
Congenital Abnormalities