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CompletedNCT03429452SALMANTICORUpdated Jun 10, 2019

The SALMANTICOR Study

An observational study in Structural Heart Abnormality, sponsored by AORTICA Group. Completed at 1 site in Spain. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2019-06-10.

Sponsored by AORTICA Group · Observational

Study type
Observational
Model
Ecologic or community
Time perspective
Prospective
Enrollment
2,057
Ages
18 Years and older
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-12

Among 594 studies in Motor Activity with a site in Spain — 147 open to participants now, 183 under way, 1 of them phase 3. Motor Activity · Spain.

Enrollment
6th of 57
2,057 · median 142
Started
2015
with 9 others
Observational
57 of 594
21 open now
Registered
121st of 594
by date

Among the 594 studies in Motor Activity with a site in Spain, this one is the 6th largest by enrollment of the 57 observational ones that give a count, is one of 10 that started in 2015, is one of 57 observational ones, and was the 121st registered.

Motor Activity

9,798 studies on the registry are indexed under Motor Activity; 1,910 are open to participants now.

Browse Motor Activity studies →

Open to participants now

147 of the 594 studies in Motor Activity with a site in Spain are open now. Recruiting first, the newest first:

142 more — sign in →

All 147 open studies →

A study can be open while its sites in Spain have not opened yet or have stopped. Only those recruiting at a site in Spain →

Who these studies take

Of the 1,201 Motor Activity studies recruiting now, 517 (43%) set no upper age limit and 535 (45%) stop at 75 or younger; 180 take children under 18; 420 take healthy volunteers.

This study: 18 Years and older · all sexes · no healthy volunteers.

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02

Study 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.

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.

03

Conditions studied

  • Structural Heart Abnormality

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Keywords

  • structural heart abnormality
  • spatial method
  • echocardiography
  • electrocardiogram
  • mediterranean diet
  • exercise
  • social status
  • rural
04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
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

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Any individual willing to participate

Exclusion criteria

Exclusion Criteria:

  • Death people not identified in the community records
  • Not able to attend the visit
05

Study design

Observational model
Ecologic or community
Time perspective
Prospective
Enrollment
2,057 participants (actual)
Target follow-up
5 Years
Patient registry
Yes
Biospecimen retention
Samples with dna
06

What researchers measure

Primary outcomes

  1. 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

    Time frame: through study completion, an average of 3 years

  2. 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

    Time frame: 5 years follow-up

07

Study locations

1 site
  • Hospital Universitario de Salamanca
    Salamanca, 37002, Spain
08

References and documents

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 ↗

Individual participant data

Plan to share: Yes

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Oct 2015 to primary completion in May 2018, 31 months.

Of 490 non-industry observational studies under Motor Activity, half reached primary completion within 22 months of starting (the median), counting those still running; a quarter within 8 and three quarters within 48. This study's 31 months is above that.

Counting every sponsor, half of 500 studies reached it within 22 months; a quarter within 8 and three quarters within 48.

How these figures are worked out, and which studies are left out of them.

Registered
Jan 10, 2018
First posted
Feb 12, 2018
StartActual
Oct 15, 2015
Primary completionActual
May 25, 2018
CompletionActual
May 2019
Last update
Jun 10, 2019
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jun 10, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03429452
Lead sponsor
AORTICA Group
Responsible party
Pedro L Sanchez (Head of Cardiology, PhD, MD, Salamanca University Hospital) — Principal investigator
First posted
Feb 12, 2018
Start date
Oct 15, 2015
Primary completion
May 25, 2018
Completion
May 2019
Last update
Jun 10, 2019

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jun 2019. You cannot join it, but the record below documents what was studied.

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