Atherosclerosis
Conditions
Brief summary
Atherosclerosis is a systemic, multifocal disease that represents the leading cause of death in Western countries. The risk factors contributing to its distribution, extent and progression in different organs (i.e., the heart, brain or limbs) and different segments (large and small vessels) are not identical. The present study analyses data the evolutionary aspects of polydistrict atherosclerosis by analysing the possible role of morphological factors, biomolecular and genetic in the progression of atherosclerotic lesions and the development of major and/or minor acute cardiovascular events. For this purpose, will be recalled to follow-up all 320 patients already enrolled in the previous protocol of Research in the period between 1 March 2014 and 28 February 2015 at the Department of Internal Medicine, Catholic University of Rome. The subjects will undergo a new clinical evaluation, with particular interest to the onset of major cardiovascular events (myocardial infarction, stroke, death for all causes) and major adverse events to the lower limbs (critical ischemia of the lower limbs requiring revascularization or amputation) in the follow-up period, and a ultrasonographic examination of carotid arteries and arteries of lower limb districts at the Service of Angiology, Catholic University of Rome. The study employed a new semiquantitative ultrasonographic score (ultrasonographic lower limb atherosclerosis (ULLA) score), that enables a complete evaluation of the entire lower limb atherosclerotic burden and has already been shown to be associated with major cardiovascular risk factors. Therefore, the aims of this study are: * to assess the association between functional, morphological, biomolecular and genetic factors of atherosclerotic disease and the risk of major cardiovascular events (MACE) and major adverse events to the lower limbs (MALE); * to analyse the morphological progression of atherosclerotic disease in its different localizations and the possible determining factors in such progression with a 10-year follow-up ultrasound study.
Interventions
DIAGNOSTIC_TESTUltrasonographic examination
Ultrasonographic examination will be performed using a high-resolution (Epiq Elite Philips Medical Systems, Monza, Italia) and a linear 12-9 MHz transducer. The patients will be placed in a supine position. Starting with the probe at the base of the neck, the common carotid artery will be explored on the transverse plane and then on the sagittal one, continuing in a cranial sense up to the carotid bifurcation. The medium-intimal thickness will be measured, defined as distance from the first hyperechoic line to the second hyperechoic line. The femoropopliteal and run-off segments will be continuously scanned from the subinguinal region to the paramalleolar region with axial and sagittal scans. All segments will be examined for the presence of vessel wall calcifications and/or atherosclerotic plaques. In addition, flow velocity measurements will be obtained using spectral Doppler imaging and color Doppler imaging.
Sponsors
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Follow-up of n.320 subjects previously enrolled in the period between 1 March 2014 and 28 February 2015 in the previous Research Protocol at the Department of Internal Medicine, Catholic University of Rome.
Exclusion criteria
* Acute diseases; * Age \< 18 years; * Inclusion in another clinical trial; * Impossibility of follow-up (homeless, residence abroad)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Assessment evolutionary aspects of atherosclerosis | 6 months | The association between functional, morphological, biomolecular and genetic factors of atherosclerotic disease and the risk of major cardiovascular events (MACE) and major adverse events to the lower limbs (MALE) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Morphological progression of atherosclerosis and factors involved | 6 months | The morphological progression of atherosclerotic disease in its different localizations and the possible determining factors related to such progression assesed by a 10-year follow-up ultrasound study |
Countries
Italy
Outcome results
None listed