Ignite Creation Date:
2024-05-06 @ 8:04 PM
Last Modification Date:
2024-10-26 @ 3:19 PM
Study NCT ID:
NCT06230406
Status:
RECRUITING
Last Update Posted:
2024-01-30
First Post:
2023-12-27
Brief Title:
T-Mem GEne in Atherosclerosis
Sponsor:
IRCCS Policlinico S Donato
Organization:
IRCCS Policlinico S Donato
Study Overview
Official Title:
Role of T-Mem GEne in the Molecular Pathogenesis of Atherosclerosis
Status:
RECRUITING
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
GEMMA
Brief 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 UO 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 16int2016 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
The results of a study conducted in the past in collaboration between the UO 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 16int2016 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
Detailed 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 carotidfemoral plaque for thromboendarterectomy artery wall for aneurysmectomylimb 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
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 carotidfemoral plaque for thromboendarterectomy artery wall for aneurysmectomylimb 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None