Atherosclerosis and Calcific Aortic Stenosis with and Without DiabetesNCT06337227
Potential Role of Sirtuins As Epigenetic Biomarkers of the Patient with Atherosclerosis or Calcific Aortic Stenosis
An observational study of Atherosclerosis and Calcific Aortic Stenosis with and Without Diabetes, run by IRCCS SYNLAB SDN at 1 site in Italy.
Trial summary
The project aims to shed light on the role of Sirtuins, enzymes belonging to the third class of histone deacetylases (class III) involved in epigenetic modifications (deacetylation), focusing mainly on Sirtuin 6 (SIRT6), as a regulator of atherosclerosis and severe aortic valve stenosis through molecular-based and… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Atherosclerosis and Calcific Aortic Stenosis with and Without Diabetes
- What is being tested?
- lncRNA signature analyses
- How many people
- 3 participants
- Where
- 1 siteItaly
- Study dates
- 19 Oct 2023to Oct 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: The study plans to recruit 100 patients admitted to AOU Federico II Cardiac Surgery in Naples subject to surgical procedure with atherosclerosis and calcific aortic stenosis with and without diabetes over a 36-month period. Patients without atherosclerosis or aortic valve stenosis will be considered as a control population and where possible included in a statistical design paired for age and sex with the study population
Who may be able to join
- Patients with atherosclerosis or calcific aortic stenosis with and without diabetes older than 18 years of either sex;
- Patients without atherosclerosis undergoing surgical procedure for endocarditis;
- Patients who will have signed informed consent
Who cannot join
- Patients for whom biological material cannot be recovered for study purposes;
- Patients who refuse to participate in the study
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
Irccs Synlab Sdn
Naples, 80143
Monica Franzese, PhD, +393334041413, direzionescientifica.irccssdn@synlab.it
About this study
Official title: Potential Role of Sirtuins As Epigenetic Biomarkers for the Clinical Management of the Patient with Atherosclerosis or Calcific Aortic Stenosis
The project aims to shed light on the role of Sirtuins, enzymes belonging to the third class of histone deacetylases (class III) involved in epigenetic modifications (deacetylation), focusing mainly on Sirtuin 6 (SIRT6), as a regulator of atherosclerosis and severe aortic valve stenosis through molecular-based and epigenetic studies in human VSMC cells.
- Being tested
- lncRNA signature analyses
- Medical subject headings
- Atherosclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
lncRNA signature analysesDiagnostic test
Specific validation experiments will be performed by Real-Time PCR (C-reactive protein), Western Blot, flow cytometry and microscopy
| Study group | Role | What they receive |
|---|---|---|
| atherosclerosis and calcific aortic stenosis with diabetes patients | Not described Receives: Diagnostic Test: lncRNA signature analyses | |
| atherosclerosis and calcific aortic stenosis without diabetes patients | Not described Receives: Diagnostic Test: lncRNA signature analyses | |
| Patients without atherosclerosis undergoing surgical procedure for endocarditis | Not described Receives: Diagnostic Test: lncRNA signature analyses |
What is being measured
The primary outcome is the main question the study is designed to answer.
To evaluate by analysis of data obtained from NGS techniques whether and which proteins belonging to the Sirtuin family may be deregulated in patients with atherosclerosis or calcific aortic stenosis
Measured: 36 months
Secondary outcomes (1)
To evaluate the experimental results achieved in the clinical-diagnostic context
Measured: 36 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Mar 2024
- Study start19 Oct 2023
- Primary completionOct 2025 (estimated)
- Study completionOct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Atherosclerosis and Calcific Aortic Stenosis with and Without DiabetesStudies of the same condition, open and under way.
- 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 3 participants (estimated)
Sponsor and investigators
- Lead sponsor
- IRCCS SYNLAB SDN
- Sponsor type
- University, hospital or other
- Collaborators
- Federico II University
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06337227
- Sponsor's protocol ID
- 2/22
- Status last verified
- Mar 2025
- First submitted
- 22 Mar 2024
- Last updated
- 11 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Potential Role of Sirtuins As Epigenetic Biomarkers for the Clinical Management of the Patient with Atherosclerosis or Calcific Aortic Stenosis
- ClinicalTrials.gov ID
- NCT06337227
- Acronym / sponsor ID
- 2/22
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 3 participants (estimated)
- Lead sponsor
- IRCCS SYNLAB SDNUniversity, hospital or other
- Collaborators
- Federico II University
- Study start
- 19 Oct 2023 (actual)
- Primary completion
- Oct 2025 (estimated)
- Study completion
- Oct 2026 (estimated)
- First posted
- 29 Mar 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.
The project aims to shed light on the role of Sirtuins, enzymes belonging to the third class of histone deacetylases (class III) involved in epigenetic modifications (deacetylation), focusing mainly on Sirtuin 6 (SIRT6), as a regulator of atherosclerosis and severe aortic valve stenosis through molecular-based and epigenetic studies in human VSMC cells.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| atherosclerosis and calcific aortic stenosis with diabetes patients | – | Diagnostic Test: lncRNA signature analyses |
| atherosclerosis and calcific aortic stenosis without diabetes patients | – | Diagnostic Test: lncRNA signature analyses |
| Patients without atherosclerosis undergoing surgical procedure for endocarditis | – | Diagnostic Test: lncRNA signature analyses |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- The study plans to recruit 100 patients admitted to AOU Federico II Cardiac Surgery in Naples subject to surgical procedure with atherosclerosis and calcific aortic stenosis with and without diabetes over a 36-month period. Patients without atherosclerosis or aortic valve stenosis will be considered as a control population and where possible included in a statistical design paired for age and sex with the study population
Key inclusion criteria (3 listed)
- Patients with atherosclerosis or calcific aortic stenosis with and without diabetes older than 18 years of either sex;
- Patients without atherosclerosis undergoing surgical procedure for endocarditis;
- Patients who will have signed informed consent
Key exclusion criteria (2 listed)
- Patients for whom biological material cannot be recovered for study purposes;
- Patients who refuse to participate in the study
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 |
|---|---|---|
| lncRNA signature analysesSpecific validation experiments will be performed by Real-Time PCR (C-reactive protein), Western Blot, flow cytometry and microscopy | Diagnostic test | Patients without atherosclerosis undergoing surgical procedure for endocarditis, atherosclerosis and calcific aortic stenosis with diabetes patients, atherosclerosis and calcific aortic stenosis without diabetes patients |
Primary outcome
To evaluate by analysis of data obtained from NGS techniques whether and which proteins belonging to the Sirtuin family may be deregulated in patients with atherosclerosis or calcific aortic stenosis
Time frame: 36 months
1 secondary outcome
To evaluate the experimental results achieved in the clinical-diagnostic context
Time frame: 36 months
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 11 Mar 2025.
- Individual participant dataSharing planned: No
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 and Calcific Aortic Stenosis with and Without Diabetes, run by IRCCS SYNLAB SDN 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 2 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 11 Mar 2025. 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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To evaluate by analysis of data obtained from NGS techniques whether and which proteins belonging to the Sirtuin family may be deregulated in patients with atherosclerosis or calcific aortic stenosis (time frame: 36 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 11 Mar 2025.