Potential Role of Sirtuins as Epigenetic Biomarkers of the Patient With Atherosclerosis or Calcific Aortic Stenosis

March 29, 2024 updated by: IRCCS SYNLAB SDN

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

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

Description

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:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
atherosclerosis and calcific aortic stenosis with diabetes patients
Diagnostic test: lncRNA signature analyses
Specific validation experiments will be performed by Real-Time PCR (C-reactive protein), Western Blot, flow cytometry and microscopy
atherosclerosis and calcific aortic stenosis without diabetes patients
Diagnostic test: lncRNA signature analyses
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
Diagnostic test: lncRNA signature analyses
Specific validation experiments will be performed by Real-Time PCR (C-reactive protein), Western Blot, flow cytometry and microscopy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
36 months

Secondary Outcome Measures

Outcome Measure
Time Frame
To evaluate the experimental results achieved in the clinical-diagnostic context
Time Frame: 36 months
36 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

IRCCS SYNLAB SDN

Collaborators

Federico II University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 19, 2023

Primary Completion (Estimated)

October 1, 2024

Study Completion (Estimated)

October 1, 2026

Study Registration Dates

First Submitted

March 22, 2024

First Submitted That Met QC Criteria

March 22, 2024

First Posted (Actual)

March 29, 2024

Study Record Updates

Last Update Posted (Actual)

April 2, 2024

Last Update Submitted That Met QC Criteria

March 29, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2/22

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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Locations

3
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