Evolutionary Aspects of Polydistrict Atherosclerosis (EAP)

Institute of Hospitalization and Scientific Care (IRCCS)

Status: Completed

Conditions: Atherosclerosis

Treatments: Diagnostic Test: Ultrasonographic examination

Study type: Observational

Funder types: Other

Identifiers

NCT06497478

6415

Details and patient eligibility

About

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.

Enrollment: 320 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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)