The SALMANTICOR Study

• Sponsor: AORTICA Group (Other)
• Overall Status: Completed
• CT.gov ID: NCT03429452
• Collaborator: University of Salamanca (Other)
• Enrollment: 2,057
• Location: 1
• Actual Duration (Months): 42.5
• Patients Per Site Per Month: 48.4

Study Details

Study Description

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	Intervention/Treatment	Phase
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 Design

• Study Type: Observational [Patient Registry]
• Actual Enrollment: 2057 participants
• Observational Model: Ecologic or Community
• Time Perspective: Prospective
• Official Title: Population-based Study to Identify Structural Heart Disease Abnormalities in a Spanish Community: Salamanca. The SALMANTICOR Study
• Actual Study Start Date: Oct 15, 2015
• Actual Primary Completion Date: May 25, 2018
• Actual Study Completion Date: May 1, 2019

Outcome Measures

Primary Outcome Measures

1. prevalence of structural heart disease in a population setting [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 [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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Any individual willing to participate

Exclusion Criteria:

• Death people not identified in the community records

• Not able to attend the visit

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Hospital Universitario de Salamanca	Salamanca		Spain	37002

Sponsors and Collaborators

• AORTICA Group
• University of Salamanca

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Pedro L Sanchez, Head of Cardiology, PhD, MD, Salamanca University Hospital
• ClinicalTrials.gov Identifier: NCT03429452
• Other Study ID Numbers: PI14/00695
• First Posted: Feb 12, 2018
• Last Update Posted: Jun 10, 2019
• Last Verified: Jun 1, 2019

• Individual Participant Data (IPD) Sharing Statement: Yes
• Plan to Share IPD: Yes
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Pedro L Sanchez, Head of Cardiology, PhD, MD, Salamanca University Hospital: structural heart abnormality; spatial method; echocardiography; electrocardiogram; mediterranean diet; exercise; social status; rural
• Additional relevant MeSH terms: Congenital Abnormalities

Study Results

No Results Posted as of Jun 10, 2019