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Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Register: ClinicalTrials.gov
Last refreshed on: 25 February 2013
Main ID:  NCT01410318
Date of registration: 02/08/2011
Primary sponsor: Fundación Centro Nacional de Investigaciones Cardiovasculares Carlos III
Public title: Progression of Early Subclinical Atherosclerosis PESA
Scientific title: Early Detection and Progression of Subclinical Atherosclerosis and Its Relationship to Coronary Risk Factors
Date of first enrolment: June 2010
Target sample size: 4000
Recruitment status: Recruiting
URL:  http://clinicaltrials.gov/show/NCT01410318
Study type:  Observational
Study design:  Observational Model: Cohort, Time Perspective: Prospective  
Countries of recruitment
Spain
Contacts
Name:   Agustín Mocoroa, PhD
Address: 
Telephone: 0034 91 289 61 32
Email: amocoroa@gruposantander.com
Affiliation: 
Name:   Borja Ibáñez, PhD
Address: 
Telephone: 0034 91 453 12 00
Email: bibanez@cnic.es
Affiliation: 
Name:   Ana Dopazo, PhD
Address: 
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Affiliation:  Centro Nacional de Investigaciones Cardiovasculares Carlos III
Name:   Borja Ibañez, PhD
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Affiliation:  Centro Nacional de Investigaciones Cardiovasculares Carlos III
Name:   Eliseo Guallar, PhD
Address: 
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Affiliation:  Centro Nacional de Investigaciones Cardiovasculares Carlos III
Name:   Gabriela Guzman, PhD
Address: 
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Affiliation:  Centro Nacional de Investigaciones Cardiovasculares Carlos III
Name:   Ginés Sanz, PhD
Address: 
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Affiliation:  Centro Nacional de Investigaciones Cardiovasculares Carlos III
Name:   Jose Luis Peñalvo, PhD
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Affiliation:  Centro Nacional de Investigaciones Cardiovasculares Carlos III
Name:   Jose María Ordovás, PhD
Address: 
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Affiliation:  Centro Nacional de Investigaciones Cardiovasculares Carlos III
Name:   Luis Jesús Jiménez Borreguero, MD
Address: 
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Affiliation:  Centro Nacional de Investigaciones Cardiovasculares Carlos III
Name:   Manuel Franco, PhD
Address: 
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Affiliation:  Centro Nacional de Investigaciones Cardiovasculares Carlos III
Name:   María Téllez, PhD
Address: 
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Affiliation:  Centro Nacional de Investigaciones Cardiovasculares Carlos III
Name:   Marta Tomás, MD
Address: 
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Affiliation:  Centro Nacional de Investigaciones Cardiovasculares Carlos III
Name:   Martín Laclaustra, PhD
Address: 
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Affiliation:  Centro Nacional de Investigaciones Cardiovasculares Carlos III
Name:   Valentín Fuster, PhD
Address: 
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Affiliation:  Centro Nacional de Investigaciones Cardiovasculares Carlos III
Key inclusion & exclusion criteria

Inclusion Criteria:

- Employees of the Banco de Santader Group

- Age between 40-54 years.

Exclusion Criteria:

- Myocardial Infarction

- Angina pectoris

- Stroke, either transient or with sequelae

- Peripheral vascular disease

- Prior angioplasty or heart surgery

- Atrial fibrillation

- Other heart diseases

Subjects with the following conditions will also be excluded:

- Pregnancy

- Active treatment for any cancer

- Morbid obesity (BMI =40)

- Renal failure with creatinine clearance <60 mL/min, as estimated by the Cockcroft and
Gault formula

- Any disease that decreases life expectation to =6 years

- Pacemaker, implantable automatic defibrillator, or any implanted device that
contraindicates MRI

- A chest CT in the previous year



Age minimum: 40 Years
Age maximum: 54 Years
Gender: Both
Health Condition(s) or Problem(s) studied
Atherosclerosis
Intervention(s)
Primary Outcome(s)
Presence of subclinical atherosclerotic disease in any imaging test; Basic imaging tests (ankle/brachial blood pressure, carotid ultrasound, abdominal aorta ultrasound and CT for calcium scoring) and advanced imaging tests (MRI and PET) [Time Frame: 6 years]
Secondary Outcome(s)
Prevalence of unrecognized myocardial infarction and its relationship to risk factors. [Time Frame: 6 years]
Secondary ID(s)
PESA CNIC-SANTANDER
Source(s) of Monetary Support
Please refer to primary and secondary sponsors
Secondary Sponsor(s)
Banco Santander
Fundación Botín
Fundaciónprocnic
Instituto de Salud Carlos III
Ministerio de Ciencia e Innovación, Spain
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