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NCT Number: NCT06230406

T-Mem GEne in Atherosclerosis

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.

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Key information

Conditions

Atherosclerosis Arterial Occlusive Diseases Arteriosclerosis Cardiovascular Diseases Vascular Diseases

Sex eligibility

All sexes

Study type

Observational

Primary location

About this study

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.

Who can participate

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

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

surgery for artherial and/or venous diseases

Procedure

collection of vascular samples from surgery and blood samples

Primary outcomes

  1. T-Mem expression

    Time frame: through study completion, an average of 2 years

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

Secondary outcomes

  1. 3D organoids

    Time frame: through study completion, an average of 2 years

    Generation of pathological 3D organoids from patient vascular samples, to study the modulation of gene expression, also using sequencing techniques.

Study contacts

Contact information is provided by the study sponsor or research team.

Mattia Ricotti

CONTACT

[email protected]

+390252774236

Sponsors and collaborators

Lead sponsor

IRCCS Policlinico S. Donato

Other

Registry information

Official study title

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

Acronym: GEMMA

Important dates

Study start
2023
Primary completion
2026
Study completion
2026
First posted
Jan 30, 2024
Registry last updated
Apr 7, 2026

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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