Progression of Early Subclinical Atherosclerosis (PESA)
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| ClinicalTrials.gov Identifier: NCT01410318 |
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Recruitment Status
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Active, not recruiting
First Posted
: August 5, 2011
Last Update Posted
: February 6, 2017
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| Condition or disease |
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| Atherosclerosis |
Atherosclerosis is the most common cardiovascular disease and accounts for the greatest number of deaths. Atherosclerotic disease starts at an early age and follows a subclinical course for decades, becoming apparent in the fifth or sixth decades of life in men and approximately 10 years later in women. Its main clinical signs include myocardial infarction, angina pectoris, sudden death, or stroke. Disease occurrence and progression are conditioned by the presence of the so-called risk factors: smoking, dyslipidemia, hypertension, and diabetes, among others. From these factors, a number of equations have been developed for predicting the risk of an individual to suffer the disease, in order to apply adequate prevention measures such as lifestyle changes or drug treatment. However, despite the proven efficacy of such interventions, cardiovascular prevention has many limitations due to three significant problems:
- The ability to predict risk from current equations is very limited because other genetic or environmental factors that may influence the course of disease are still unknown.
- The ability for early prediction of cardiovascular risk from current equations is even more limited in individuals under 55 years of age.
- Atherosclerotic disease is diagnosed too late, usually when the condition is very advanced and lesions are already irreversible, or when it has caused clinical signs or events in organs or territories vascularized by the diseased arteries. Clinical procedures currently used for detection of myocardial ischemia are however poorly sensitive and specific in the asymptomatic general population.
Technological advances made in the past decade in both laboratory tests and medical imaging have opened up new expectations for detection and treatment of atherosclerotic disease. Current research is focused on two aspects:
- To improve the ability to predict the disease by incorporating risk factors obtained from the laboratory such as C-reactive protein, homocysteine, fibrinogen, myeloperoxidase, or lipoprotein-associated phospholipase A2. At the same time, development of genetics and the new so-called "omics" techniques allows for exploring the genetic variability of individuals and its contribution to development of the disease and its complications. Such technologies include genomics, epigenetics, transcriptomics, proteomics, and metabolomics.
- To detect the disease at an early stage using the advanced imaging techniques, which may be used with no or minimal risks in large population groups. Use of magnetic resonance imaging (MRI) with and without contrast, computed tomography (CT), and positron emission tomography (PET) allows not only for identifying subclinical lesions, but also for studying the mechanisms of disease and for monitoring its course.
Very few population studies making combined use of some of these procedures are available. The actual potential of this approach and the impact it may have on early diagnosis of subclinical atherosclerosis, its progression, and its relationship to risk factors have not been assessed to date.
| Study Type : | Observational |
| Actual Enrollment : | 4184 participants |
| Observational Model: | Cohort |
| Time Perspective: | Prospective |
| Official Title: | Early Detection and Progression of Subclinical Atherosclerosis and Its Relationship to Coronary Risk Factors |
| Study Start Date : | June 2010 |
| Estimated Primary Completion Date : | April 2019 |
| Estimated Study Completion Date : | April 2019 |
- To assess the prevalence and 6-year progression rate of subclinical atherosclerotic disease in a population aged 40-54 years using basic and advanced cardiovascular imaging techniques. [ Time Frame: 6 years ]
The basic imaging tests consist of vascular 2D and 3D ultrasound in carotid, aorta and ilio-femoral arteries and computed tomography (CT) for coronary artery calcification. The advanced imaging test consist of magnetic resonance imaging (MRI) and 18F-fluorodeoxyglucose-positron emission tomography (18FDG PET) in carotid and ilio-femoral territories.
These imaging techniques enable early detection of subclinical atherosclerosis, characterization of the atherosclerotic burden, and monitoring of disease progression.
- To assess the association of both emerging and traditional cardiovascular risk factors with progression of subclinical atherosclerotic disease. [ Time Frame: 6 years ]The main emerging risk factors to be investigated will be genetic markers (using genome-wide association scans), epigenetic markers (by genome-wide analysis of DNA methylation), and metabolomic markers (metabolomic profile in serum). Conventional factors are defined as those included in the prediction equations (European SCORE equation for Mediterranean countries and REGICOR), dietary habits, physical activity, and psychosocial characteristics.
- To characterize the composition and evolution of atherosclerotic lesions using MRI and 18FDG PET to determine their relationship to risk factors and genetic, epigenetic, metabolomic, and environmental factors. [ Time Frame: 6 years ]
- To assess the prevalence and progression of subclinical atherosclerosis in perimenopausal women and its relationship to cardiovascular risk factors and hormonal changes. [ Time Frame: 6 years ]
Biospecimen Retention: Samples With DNA
- Orine (4 x 5 mL)
- Blood (8 x 0.6 mL)
- Serum (8 x 0.6 mL)
- EDTA plasma (8 x 0.6 mL)
- Buffy Coat (2 x 0.6 mL)
- Non insultated RNA (2 x 5 mL PAXgene)
- Insulated DNA (2 x 0.3 mL, 150 ng/microL + 1 x 0.3 mL, 75 ng/microL)
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| Ages Eligible for Study: | 40 Years to 54 Years (Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | Yes |
| Sampling Method: | Non-Probability Sample |
Inclusion Criteria:
- Employees of the Banco de Santander 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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01410318
| Spain | |
| Ciudad Financiera del Grupo Santander | |
| Boadilla del Monte, Madrid, Spain, 28660 | |
| Principal Investigator: | Valentín Fuster, PhD | Centro Nacional de Investigaciones Cardiovasculares Carlos III | |
| Study Director: | Antonio I Fernández Ortiz, PhD | Centro Nacional de Investigaciones Cardiovasculares Carlos III | |
| Study Chair: | Borja Ibañez, PhD | Centro Nacional de Investigaciones Cardiovasculares Carlos III | |
| Study Chair: | Ginés Sanz, PhD | Centro Nacional de Investigaciones Cardiovasculares Carlos III | |
| Study Chair: | Jose María Ordovás, PhD | Centro Nacional de Investigaciones Cardiovasculares Carlos III | |
| Study Chair: | Luis Jesús Jiménez Borreguero, MD | Centro Nacional de Investigaciones Cardiovasculares Carlos III | |
| Study Chair: | Jose Luis Peñalvo, PhD | Centro Nacional de Investigaciones Cardiovasculares Carlos III | |
| Study Chair: | Martín Laclaustra, PhD | Centro Nacional de Investigaciones Cardiovasculares Carlos III | |
| Study Chair: | Ana Dopazo, PhD | Centro Nacional de Investigaciones Cardiovasculares Carlos III | |
| Study Chair: | Leticia Fernández Friera, PhD | Centro Nacional de Investigaciones Cardiovasculares Carlos III | |
| Study Chair: | Agustin Mocoroa, MD | Banco Santander | |
| Study Chair: | Beatriz Lopez Melgar, MD | Centro Nacional de Investigaciones Cardiovasculares Carlos III |
Additional Information:
Publications of Results:
Other Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Fundación Centro Nacional de Investigaciones Cardiovasculares Carlos III |
| ClinicalTrials.gov Identifier: | NCT01410318 History of Changes |
| Other Study ID Numbers: |
PESA CNIC-SANTANDER |
| First Posted: | August 5, 2011 Key Record Dates |
| Last Update Posted: | February 6, 2017 |
| Last Verified: | February 2017 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | Undecided |
Keywords provided by Fundación Centro Nacional de Investigaciones Cardiovasculares Carlos III:
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Atherosclerosis PESA Subclinical Cardiovascular diseases Coronary disease |
Heart diseases Heart Failure Myocardial Infarction Stroke Arteriosclerosis |
Additional relevant MeSH terms:
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Atherosclerosis Arteriosclerosis Arterial Occlusive Diseases Vascular Diseases Cardiovascular Diseases |