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Completed

NCT Number: NCT06497478

Evolutionary Aspects of Polydistrict Atherosclerosis

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Fondazione Policlinico Universitario A. Gemelli IRCCS, UOC Medicina Interna

Roma, 00168, Italy

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Ultrasonographic examination

Diagnostic Test

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.

Primary outcomes

  1. Assessment evolutionary aspects of atherosclerosis

    Time frame: 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 outcomes

  1. Morphological progression of atherosclerosis and factors involved

    Time frame: 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

Sponsors and collaborators

Lead sponsor

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Other

Registry information

Official study title

Evolutionary Aspects of Polydistrict Atherosclerosis (EAP). Analysis and Correlation of Functional, Biomolecular and Genetic Factors.

Acronym: EAP

Important dates

Study start
2014
Primary completion
2024
Study completion
2025
First posted
Jul 11, 2024
Registry last updated
Sep 8, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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