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临床试验/NCT06230406
NCT06230406招募中不适用

Role of T-Mem GEne in the Molecular Pathogenesis of Atherosclerosis

IRCCS Policlinico S. Donato1 个研究点 分布在 1 个国家目标入组 12 人开始时间: 2023年9月28日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
12
试验地点
1
主要终点
T-Mem expression

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Observational
观察模型
Other
时间视角
Cross Sectional

入排标准

性别
All
接受健康志愿者
否

入选标准

  • •adult patients (age > 18 years)
  • •consent to participate in the study,
  • •patients coming to the Vascular Surgery Unit I of the IRCCS Policlinico San Donato for a vascular pathology of the arterial or venous district worthy of surgical treatment.

排除标准

  • •minor patients,
  • •patients who have not given their consent to participate in the study,
  • •patients who have vascular pathologies of the arterial or venous district not susceptible to surgical intervention.

结局指标

主要结局

T-Mem expression

时间窗: through study completion, an average of 2 years

Analysis of the gene expression profile in different vascular and blood samples.

次要结局

  • 3D organoids(through study completion, an average of 2 years)

研究者

发起方
IRCCS Policlinico S. Donato
申办方类型
Other
责任方
Principal Investigator
主要研究者

Daniela Mazzaccaro

Vascular Surgeon, Researcher, PI

IRCCS Policlinico S. Donato

研究点 (1)

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