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Evolutionary Aspects of Polydistrict Atherosclerosis

NCT06497478 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 320

Last updated 2025-09-08

No results posted yet for this study

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.

Conditions

Interventions

DIAGNOSTIC_TEST

Ultrasonographic 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 & Collaborators

  • Fondazione Policlinico Universitario Agostino Gemelli IRCCS

    lead OTHER

Principal Investigators

  • luca Santoro · Fondazione Policlinico Universitario A. Gemelli, IRCCS

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-09-01
Primary Completion
2024-12-30
Completion
2025-02-28

Countries

  • Italy

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06497478 on ClinicalTrials.gov