The SALMANTICOR Study

Structural Heart Abnormality Clinical Trial

— SALMANTICOR  

Official title:

Population-based Study to Identify Structural Heart Disease Abnormalities in a Spanish Community: Salamanca. The SALMANTICOR Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03429452
• Other study ID #: PI14/00695
• Status: Completed
• Start date: October 15, 2015
• Est. completion date: May 2019

Study information

• Verified date: June 2019
• Source: AORTICA Group
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 2057
• Est. completion date: May 2019
• Est. primary completion date: May 25, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Any individual willing to participate

Exclusion Criteria:

• Death people not identified in the community records

• Not able to attend the visit

Related Conditions & MeSH terms

• Congenital Abnormalities
• Structural Heart Abnormality

Locations

Country	Name	City	State
Spain	Hospital Universitario de Salamanca	Salamanca

Sponsors (2)

Lead Sponsor	Collaborator
AORTICA Group	University of Salamanca

Country where clinical trial is conducted

Spain, 

References & Publications (1)

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, Herna — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	through study completion, an average of 3 years
Primary	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	5 years follow-up