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

NCT06337227 | Recruiting

• 1 other identifier: 2/22
• Study Type: observational
• Target: 3
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Atherosclerosis and Calcific Aortic Stenosis with and Without Diabetes

Outcome Measures

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

  36 months

Secondary Outcomes (1)

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

  36 months

Study Arms (3)

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

lncRNA signature analyses DIAGNOSTIC_TEST

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

Patients without atherosclerosis undergoing surgical procedure for endocarditis; atherosclerosis and calcific aortic stenosis with diabetes patients; atherosclerosis and calcific aortic stenosis without diabetes patients

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• IRCCS SYNLAB SDN: lead
• Federico II University: collaborator

Study Sites (1)

Irccs Synlab Sdn

Naples, 80143, Italy

RECRUITING

MeSH Terms

Conditions

Atherosclerosis

Condition Hierarchy (Ancestors)

Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Cardiovascular Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 22, 2024
• First Posted: March 29, 2024
• Study Start: October 19, 2023
• Primary Completion: October 1, 2025
• Study Completion (Estimated): October 1, 2026
• Last Updated: March 11, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)