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

ConditionAtherosclerosis and Calcific Aortic Stenosis with and Without Diabetes

Trial statusRecruiting

Trial phaseNot listed

Trial typeObservational

Biological sexAll

Age18+

SponsorIRCCS SYNLAB SDN

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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

Disqualifiers

Patients for whom biological material cannot be recovered for study purposes;

Patients who refuse to participate in the study

Trial 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

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

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

Treatment groups

3 Participants

are divided into 3 treatment groups

Group A: atherosclerosis and calcific aortic stenosis with diabetes patients1 intervention

Group B: atherosclerosis and calcific aortic stenosis without diabetes patients1 intervention

Group C: Patients without atherosclerosis undergoing surgical procedure for endocarditis1 intervention

Trial outcomes

Primary outcomes

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

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

Time frame

36 months

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

IRCCS SYNLAB SDN

Lead sponsor

Federico II University

Collaborator

Source ClinicalTrials.gov

Apply now