T-Mem GEne in Atherosclerosis

NCT06230406 | Recruiting

• 1 other identifier: GEMMA V1 - 35/int/2023
• Study Type: observational
• Target: 12
• Locations: 1 country
• Sites: 1

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 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.

Conditions

Atherosclerosis

Outcome Measures

Primary Outcomes (1)

• T-Mem expression

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

  through study completion, an average of 2 years

Secondary Outcomes (1)

• 3D organoids

  through study completion, an average of 2 years

Interventions

surgery for artherial and/or venous diseases PROCEDURE

collection of vascular samples from surgery and blood samples

Eligibility Criteria

• Sex: all
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

All patients coming to the Operative Unit of Vascular Surgery at IRCCS Policlinico San Donato, needing open surgical intervention for arterial and/or venous pathologies

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• IRCCS Policlinico S. Donato: lead

Study Sites (1)

I.R.C.C.S. Policlinico San Donato

San Donato Milanese, Milan, 20097, Italy

RECRUITING

Related Publications (3)

• Virani SS, Alonso A, Benjamin EJ, Bittencourt MS, Callaway CW, Carson AP, Chamberlain AM, Chang AR, Cheng S, Delling FN, Djousse L, Elkind MSV, Ferguson JF, Fornage M, Khan SS, Kissela BM, Knutson KL, Kwan TW, Lackland DT, Lewis TT, Lichtman JH, Longenecker CT, Loop MS, Lutsey PL, Martin SS, Matsushita K, Moran AE, Mussolino ME, Perak AM, Rosamond WD, Roth GA, Sampson UKA, Satou GM, Schroeder EB, Shah SH, Shay CM, Spartano NL, Stokes A, Tirschwell DL, VanWagner LB, Tsao CW; American Heart Association Council on Epidemiology and Prevention Statistics Committee and Stroke Statistics Subcommittee. Heart Disease and Stroke Statistics-2020 Update: A Report From the American Heart Association. Circulation. 2020 Mar 3;141(9):e139-e596. doi: 10.1161/CIR.0000000000000757. Epub 2020 Jan 29.

  PMID: 31992061 RESULT

• Tian K, Xu Y, Sahebkar A, Xu S. CD36 in Atherosclerosis: Pathophysiological Mechanisms and Therapeutic Implications. Curr Atheroscler Rep. 2020 Aug 9;22(10):59. doi: 10.1007/s11883-020-00870-8.

  PMID: 32772254 RESULT

• Cocola C, Magnaghi V, Abeni E, Pelucchi P, Martino V, Vilardo L, Piscitelli E, Consiglio A, Grillo G, Mosca E, Gualtierotti R, Mazzaccaro D, La Sala G, Di Pietro C, Palizban M, Liuni S, DePedro G, Morara S, Nano G, Kehler J, Greve B, Noghero A, Marazziti D, Bussolino F, Bellipanni G, D'Agnano I, Gotte M, Zucchi I, Reinbold R. Transmembrane Protein TMEM230, a Target of Glioblastoma Therapy. Front Cell Neurosci. 2021 Nov 17;15:703431. doi: 10.3389/fncel.2021.703431. eCollection 2021.

  PMID: 34867197 RESULT

Biospecimen

Retention: SAMPLES WITH DNA

Vascular tissue, blood samples

MeSH Terms

Conditions

Atherosclerosis

Interventions

Surgical Procedures, Operative

Condition Hierarchy (Ancestors)

Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Cardiovascular Diseases

Central Study Contacts

Mattia Ricotti

CONTACT

+390252774236; mattia.ricotti@grupposandonato.it

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Vascular Surgeon, Researcher, PI

Study Record Dates

• First Submitted: December 27, 2023
• First Posted: January 30, 2024
• Study Start: September 28, 2023
• Primary Completion: March 1, 2025
• Study Completion: March 1, 2025
• Last Updated: October 8, 2024

Record last verified: 2024-10

Locations

IT (1)