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Progression of Early Subclinical Atherosclerosis (PESA)

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ClinicalTrials.gov Identifier: NCT01410318
Recruitment Status : Unknown
Verified February 2017 by Fundación Centro Nacional de Investigaciones Cardiovasculares Carlos III.
Recruitment status was:  Active, not recruiting
First Posted : August 5, 2011
Last Update Posted : February 6, 2017
Sponsor:
Collaborator:
Grupo Santander
Information provided by (Responsible Party):
Fundación Centro Nacional de Investigaciones Cardiovasculares Carlos III

Tracking Information
First Submitted Date August 2, 2011
First Posted Date August 5, 2011
Last Update Posted Date February 6, 2017
Study Start Date June 2010
Estimated Primary Completion Date April 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: July 9, 2014)
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.
Original Primary Outcome Measures
 (submitted: August 4, 2011)
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 ]
Change History
Current Secondary Outcome Measures
 (submitted: July 9, 2014)
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.
Original Secondary Outcome Measures
 (submitted: August 4, 2011)
Prevalence of unrecognized myocardial infarction and its relationship to risk factors. [ Time Frame: 6 years ]
Current Other Pre-specified Outcome Measures
 (submitted: July 9, 2014)
  • 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 ]
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Progression of Early Subclinical Atherosclerosis
Official Title Early Detection and Progression of Subclinical Atherosclerosis and Its Relationship to Coronary Risk Factors
Brief Summary The overall objective of this study is to characterize the prevalence and progression rate of subclinical atherosclerotic lesions and to study their association to the imaging characteristics of atheroma plaques and to the presence of genetic, epigenetic, metabolomic, and environmental factors, including dietary habits, physical activity, biorhythms, psychosocial characteristics, and exposure to environmental pollutants
Detailed Description

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:

  1. 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.
  2. The ability for early prediction of cardiovascular risk from current equations is even more limited in individuals under 55 years of age.
  3. 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:

  1. 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.
  2. 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
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Retention:   Samples With DNA
Description:
  • 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)
Sampling Method Non-Probability Sample
Study Population The target population of the study consists of employees (N= 4000) of the Banco de Santander Group in the Madrid region (65% males and 35% females, aged 40-54 years).
Condition Atherosclerosis
Intervention Not Provided
Study Groups/Cohorts Not Provided
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Unknown status
Actual Enrollment
 (submitted: July 9, 2014)
4184
Original Estimated Enrollment
 (submitted: August 4, 2011)
4000
Estimated Study Completion Date April 2019
Estimated Primary Completion Date April 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria

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
Sex/Gender
Sexes Eligible for Study: All
Ages 40 Years to 54 Years   (Adult)
Accepts Healthy Volunteers Yes
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Spain
Removed Location Countries  
 
Administrative Information
NCT Number NCT01410318
Other Study ID Numbers PESA CNIC-SANTANDER
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement
Plan to Share IPD: Undecided
Responsible Party Fundación Centro Nacional de Investigaciones Cardiovasculares Carlos III
Study Sponsor Fundación Centro Nacional de Investigaciones Cardiovasculares Carlos III
Collaborators Grupo Santander
Investigators
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
PRS Account Fundación Centro Nacional de Investigaciones Cardiovasculares Carlos III
Verification Date February 2017