T-Mem GEne in Atherosclerosis — GEMMA  

Atherosclerosis Clinical Trial

Official title: Role of T-Mem GEne in the Molecular Pathogenesis of Atherosclerosis

Status Recruiting

Clinical Trial Summary

Atherosclerosis is the main cause of cardiovascular diseases and is characterized by the progressive accumulation of lipids and inflammatory cells such as macrophages and lymphocytes within the vessel wall of large and medium-sized arteries, forming the so-called "atherosclerotic plaques". The formation process of these lesions is different depending on the age, genetics and physiological state of the individual affected. Furthermore, behavioral factors and the lifestyle of each individual play a key role, which can lead to the presence of a series of pro-atherosclerotic pathologies and risk factors, such as in particular systemic arterial hypertension, dyslipidemia, hyperglycemia and cigarette smoking. However, the precise molecular mechanisms underlying this pathogenetic process are still under investigation.

The results of a study conducted in the past in collaboration between the U.O. have recently been published. of Vascular Surgery and the laboratory of Dr. I. Zucchi of the Institute of Biomedical Technologies of the CNR of Milan Segrate (Protocol GEMMA NUOVA, 16/int/2016), which describes that the overexpression of a newly identified gene (TMEM230) it may have a role in the formation of atherosclerotic vascular disorders, but it is still unclear how the expression of this gene is modulated in vivo.

Knowledge of these factors would increase the knowledge of the molecular mechanisms underlying atherosclerosis and could represent a possible target for prevention and targeted pharmacological treatment, with consequent potential reduction in disability or mortality from cardiovascular diseases.

Clinical Trial Description

The proposed study aims to analyze, in patients suffering from vascular pathologies, the modulation of the expression of the TMEM230 gene, identified in the laboratory of Dr. I. Zucchi of the Institute of Biomedical Technologies (CNR of Milan Segrate), and its role in the molecular mechanisms of atherosclerosis.

This collaboration aims to collect a series of patients with different vascular pathologies.

This is a transversal genetic study, which involves the analysis of approximately 12 samples of vascular tissue of various types coming from the intraoperative removal of material that is normally disposed of in appropriate containers for biological waste. In particular, the vascular samples will be represented by: varicose veins (for varicectomies), carotid/femoral plaque (for thromboendarterectomy), artery wall (for aneurysmectomy/limb amputations). Alongside the collection of these samples, 5 ml of venous blood will also be collected from a peripheral venous access already positioned on the patient for the surgical procedure, regardless of the study in question.

The study requires that the samples taken be temporarily stored in order to guarantee correct analysis, according to the methods described below, and destroyed at the end of the study. ;

Related Conditions & MeSH terms

• Atherosclerosis

• NCT number: NCT06230406
• Study type: Observational
• Source: IRCCS Policlinico S. Donato
• Contact: Mattia Ricotti
• Phone: +390252774236
• Email: mattia.ricotti@grupposandonato.it
• Status: Recruiting
• Start date: September 28, 2023
• Completion date: March 2024