CClinicalTrials.gg
RecruitingNCT06337227Updated Mar 11, 2025

Potential Role of Sirtuins As Epigenetic Biomarkers of the Patient with Atherosclerosis or Calcific Aortic Stenosis

An observational study in Atherosclerosis and Calcific Aortic Stenosis with and Without Diabetes, sponsored by IRCCS SYNLAB SDN. Recruiting at 1 site in Italy. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-03-11.

Sponsored by IRCCS SYNLAB SDN · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
3
Ages
18 Years and older
Sex
All
01

Study 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 epigenetic studies in human VSMC cells.

02

Conditions studied

  • Atherosclerosis and Calcific Aortic Stenosis with and Without Diabetes
03

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Probability sample

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

Inclusion criteria

  • 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

Exclusion criteria

Exclusion Criteria:

  • Patients for whom biological material cannot be recovered for study purposes;
  • Patients who refuse to participate in the study
04

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
3 participants (estimated)
Patient registry
No

Groups and cohorts

  • 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

Interventions

  • Diagnostic testlncRNA signature analyses

    Specific validation experiments will be performed by Real-Time PCR (C-reactive protein), Western Blot, flow cytometry and microscopy

05

What researchers measure

Primary outcomes

  1. 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

Secondary outcomes

  1. To evaluate the experimental results achieved in the clinical-diagnostic context

    Time frame: 36 months

06

Study locations

1 of 1 sites recruiting
07

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT06337227
Lead sponsor
IRCCS SYNLAB SDN
Collaborators
Federico II University
Responsible party
Sponsor
First posted
Mar 29, 2024
Start date
Oct 19, 2023
Primary completion
Oct 2025 (estimated)
Completion
Oct 2026 (estimated)
Last update
Mar 11, 2025

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Interested in this study?

Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.

No contact was published for this record. The registry link below has the sponsor’s details.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion