Clinical trial NCT06497478: Evolutionary Aspects of Polydistrict Atherosclerosis
Official title: Evolutionary Aspects of Polydistrict Atherosclerosis (EAP). Analysis and Correlation of Functional, Biomolecular and Genetic Factors.
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Atherosclerosis
Lead sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Sponsor class: OTHER
First posted: 2024-07-11
Enrollment: 320
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The population includes males and females, older than 18 years, who go to the the Department of Internal Medicine, Catholic University of Rome for a follow-up visit involving a medical history assessment, an objective examination and the performance of ultrasound examinations. The study previews the recruitment of subjects already gone to the aforementioned department in the period between 1 July 2014 and 30 June 2015. Patients should have symptoms related to peripheral arterial disease of the lower limbs and/or known cardiovascular risk factors, also in the absence of symptoms.

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.


Eligibility criteria: 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)

Primary outcomes:
measure: Assessment evolutionary aspects of atherosclerosis
timeFrame: 6 months
Secondary outcomes:
measure: Morphological progression of atherosclerosis and factors involved
timeFrame: 6 months
Other outcomes:
Locations:
city: Roma
country: Italy
facility: Fondazione Policlinico Universitario A. Gemelli IRCCS, UOC Medicina Interna
Study officials:
affiliation: Fondazione Policlinico Universitario A. Gemelli, IRCCS
name: luca Santoro
role: PRINCIPAL_INVESTIGATOR
References: