AtherosclerosisGEMMANCT06230406
T-Mem GEne in Atherosclerosis
An observational study of Atherosclerosis, run by IRCCS Policlinico S. Donato at 1 site in Italy.
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". Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Atherosclerosis
- What is being tested?
- surgery for artherial and/or venous diseases
- Type of treatment
- Surgery or procedure
- How many people
- 12 participants
- Where
- 1 siteItaly
- Study dates
- 28 Sep 2023to Dec 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Child, Adult, Older adult
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
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Italy1 site, 1 recruiting
- Recruiting
I.R.C.C.S. Policlinico San Donato
San Donato Milanese, Milan, 20097
Daniela Mazzaccaro, MD, PhD, + 39 025277 ext. 4341, daniela.mazzaccaro@grupposandonato.it
Giovanni Nano, MD, PhD, + 39 025277 ext. 4341, giovanni.nano@grupposandonato.it
About this study
Official title: Role of T-Mem GEne in the Molecular Pathogenesis of 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.
Read the 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), 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.
- Conditions
- Atherosclerosis
- Being tested
- surgery for artherial and/or venous diseases
- Medical subject headings
- Atherosclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
surgery for artherial and/or venous diseasesProcedure or surgery
collection of vascular samples from surgery and blood samples
What is being measured
The primary outcome is the main question the study is designed to answer.
T-Mem expression
Analysis of the gene expression profile in different vascular and blood samples.
Measured: through study completion, an average of 2 years
Secondary outcomes (1)
3D organoids
Generation of pathological 3D organoids from patient vascular samples, to study the modulation of gene expression, also using sequencing techniques.
Measured: through study completion, an average of 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jan 2024
- Study start28 Sep 2023
- Primary completionDec 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for AtherosclerosisStudies of the same condition, open and under way.
- More trials run by IRCCS Policlinico S. DonatoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 12 participants (estimated)
Sponsor and investigators
- Lead sponsor
- IRCCS Policlinico S. Donato
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Daniela Mazzaccaro, IRCCS Policlinico S. Donato
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06230406
- Sponsor's protocol ID
- GEMMA V1 - 35/int/2023
- Acronym
- GEMMA
- Status last verified
- Apr 2026
- First submitted
- 27 Dec 2023
- Last updated
- 7 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 31992061Tian 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.
PubMed 32772254Cocola 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.
PubMed 34867197
Study at a glance
From the registry record, last updated by the sponsor on 7 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Role of T-Mem GEne in the Molecular Pathogenesis of Atherosclerosis
- ClinicalTrials.gov ID
- NCT06230406
- Acronym / sponsor ID
- GEMMA / GEMMA V1 - 35/int/2023
- Conditions
- Atherosclerosis
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 12 participants (estimated)
- Lead sponsor
- IRCCS Policlinico S. DonatoUniversity, hospital or other
- Study start
- 28 Sep 2023 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 30 Jan 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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), 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.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
Who may qualify
- Sex
- All
- Age groups
- Child, Adult, Older adult
- 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
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| surgery for artherial and/or venous diseasescollection of vascular samples from surgery and blood samples | Procedure or surgery | – |
Primary outcome
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.
1 secondary outcome
3D organoids
Time frame: through study completion, an average of 2 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Apr 2026.
- Results publication: PubMed 31992061Virani 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.
- Results publication: PubMed 32772254Tian 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.
- Results publication: PubMed 34867197Cocola 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Atherosclerosis, run by IRCCS Policlinico S. Donato at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 7 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Mattia Ricotti (+390252774236, mattia.ricotti@grupposandonato.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
T-Mem expression (time frame: through study completion, an average of 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06230406, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Apr 2026.