Evolutionary Aspects of Polydistrict Atherosclerosis

NCT06497478 | Completed

• 1 other identifier: 6415
• Study Type: observational
• Target: 320
• Locations: 1 country
• Sites: 1

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.

Conditions

Atherosclerosis

Outcome Measures

Primary Outcomes (1)

• Assessment evolutionary aspects of atherosclerosis

  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)

  6 months

Secondary Outcomes (1)

• Morphological progression of atherosclerosis and factors involved

  6 months

Interventions

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• Acute diseases;
• Age \< 18 years;
• Impossibility of follow-up (homeless, residence abroad)

Sponsors & Collaborators

• Fondazione Policlinico Universitario Agostino Gemelli IRCCS: lead

Study Sites (1)

Fondazione Policlinico Universitario A. Gemelli IRCCS, UOC Medicina Interna

Roma, 00168, Italy

Location

MeSH Terms

Conditions

Atherosclerosis

Condition Hierarchy (Ancestors)

Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Cardiovascular Diseases

Study Officials

• luca Santoro

  Fondazione Policlinico Universitario A. Gemelli, IRCCS

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 5, 2024
• First Posted: July 11, 2024
• Study Start: September 1, 2014
• Primary Completion: December 30, 2024
• Study Completion: February 28, 2025
• Last Updated: September 8, 2025

Record last verified: 2014-09

Locations

IT (1)