NCT03429452

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
2,057

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Oct 2015

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 15, 2015

Completed
2.2 years until next milestone

First Submitted

Initial submission to the registry

January 10, 2018

Completed
1 month until next milestone

First Posted

Study publicly available on registry

February 12, 2018

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 25, 2018

Completed
11 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2019

Completed
Last Updated

June 10, 2019

Status Verified

June 1, 2019

Enrollment Period

2.6 years

First QC Date

January 10, 2018

Last Update Submit

June 6, 2019

Conditions

Keywords

structural heart abnormalityspatial methodechocardiographyelectrocardiogrammediterranean dietexercisesocial statusrural

Outcome Measures

Primary Outcomes (2)

  • 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

  • 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

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

2400 individuals, stratifies by place of residence (rural and urban), by age and by sex, in a Spanish community: Salamanca

You may qualify if:

  • Any individual willing to participate

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital Universitario de Salamanca

Salamanca, 37002, Spain

Location

Related 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, 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.

Biospecimen

Retention: SAMPLES WITH DNA

Biomarkers and DNA samples will be stored in a biobank

MeSH Terms

Conditions

Motor Activity

Condition Hierarchy (Ancestors)

Behavior

Study Design

Study Type
observational
Observational Model
ECOLOGIC OR COMMUNITY
Time Perspective
PROSPECTIVE
Target Duration
5 Years
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Head of Cardiology, PhD, MD

Study Record Dates

First Submitted

January 10, 2018

First Posted

February 12, 2018

Study Start

October 15, 2015

Primary Completion

May 25, 2018

Study Completion

May 1, 2019

Last Updated

June 10, 2019

Record last verified: 2019-06

Data Sharing

IPD Sharing
Will share

Locations