The Progression and Early detection of Subclinical Atherosclerosis (PESA) study: Rationale and design - 22/11/13

Doi : 10.1016/j.ahj.2013.08.024

Antonio Fernández-Ortiz, MD, PhD ^a,^b, L. Jesús Jiménez-Borreguero, MD ^a,^c, José L. Peñalvo, PhD ^a, José M. Ordovás, PhD ^a,^d, Agustín Mocoroa, MD ^e, Leticia Fernández-Friera, MD, PhD ^a,^f, Martín Laclaustra, MD, PhD ^a, Laura García, BSc ^a, Jesús Molina, BSc ^a, José M. Mendiguren, MD ^e, Beatriz López-Melgar, MD ^a, Vicente Martínez de Vega, MD ^g, Juan C. Alonso-Farto, MD, PhD ^h, Eliseo Guallar, MD, PhD ^a,ⁱ, Henrik Sillesen, MD, DMSc ^j, James H.F. Rudd, MD, PhD ^k, Zahi A. Fayad, PhD ^l, Borja Ibañez, MD, PhD ^a,^b, Ginés Sanz, MD, PhD ^a, Valentín Fuster, MD, PhD ^a,^l,^{^⁎}
^a Centro Nacional de Investigaciones Cardiovasculares Carlos III (CNIC), Madrid, Spain
^b Hospital Clínico San Carlos, Madrid, Spain
^c Hospital Universitario La Princesa, Madrid, Spain
^d US Department of Agriculture Human Nutrition Research Center on Aging, Tufts University, Boston, MA
^e Banco de Santander, Madrid, Spain
^f Hospital Universitario Montepríncipe, Madrid, Spain
^g Hospital Universitario Quirón, Madrid, Spain
^h Hospital General Universitario Gregorio Marañón, Madrid, Spain
ⁱ Johns Hopkins University Bloomberg School of Public Health, Baltimore, MD
^j Rigshospitalet, University of Copenhagen, Copenhagen, Denmark
^k Division of Cardiovascular Medicine, Cambridge University, Cambridge, United Kingdom
^l Mount Sinai School of Medicine, New York, NY

^⁎Reprint requests: Valentin Fuster, MD, PhD, “Epidemiology, Atherothrombosis and Imaging” Department, Centro Nacional de Investigaciones Cardiovasculares Carlos III (CNIC). c/Melchor Fernández Almagro, 3. 28029, Madrid, Spain.

Résumé

Background

The presence of subclinical atherosclerosis is a likely predictor of cardiovascular events; however, factors associated with the early stages and progression of atherosclerosis are poorly defined.

Objective

The PESA study examines the presence of subclinical atherosclerosis by means of noninvasive imaging and prospectively analyzes the determinants associated with its development and progression in a middle-aged population.

Methods

The PESA study is an observational, longitudinal and prospective cohort study in a target population of 4000 healthy subjects (40-54 years old, 35% women) based in Madrid (Spain). Recruitment began in June 2010 and will be completed by the end of 2013. Baseline examination consists of (1) assessment for cardiovascular risk factors (including lifestyle and psychosocial factors); (2) screening for subclinical atherosclerosis using 2D/3D ultrasound in carotid, abdominal aorta and iliofemoral arteries, and coronary artery calcium score (CACS) by computed tomography; and (3) blood sampling for determination of traditional risk factors, advanced “omics” and biobanking. In addition, a subgroup of 1300 participants with evidence of atherosclerosis on 2D/3D ultrasound or CACS will undergo a combined ¹⁸F-fluorodeoxyglucose–positron emission tomography/magnetic resonance imaging (¹⁸FDG PET/MRI) study of carotid and iliofemoral arteries. Follow-up at 3 and 6 years will include a repetition of baseline measurements, except for the ¹⁸FDG PET/MRI study, which will be repeated at 6 years.

Conclusions

The PESA study is expected to identify new imaging and biological factors associated with the presence and progression of atherosclerosis in asymptomatic people and will help to establish a more personalized management of medical care.

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Plan

Study objectives

Study design and population

Data collection

Diet, behavior, and lifestyle habits

Basic imaging studies

Advanced imaging studies

Laboratory analysis and biobanking

Clinical events

Statistical analysis plan

Discussion

Disclosures

Clinical trial registration: Clinicaltrials.gov NCT01410318.

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Vol 166 - N° 6

P. 990-998 - décembre 2013 Retour au numéro

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The Progression and Early detection of Subclinical Atherosclerosis (PESA) study: Rationale and design - 22/11/13

Résumé

Background

Objective

Methods

Conclusions

Plan

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