Ignite Creation Date:
2025-12-25 @ 5:19 AM
Ignite Modification Date:
2025-12-26 @ 4:27 AM
Study NCT ID:
NCT06337227
Status:
RECRUITING
Last Update Posted:
2025-03-11
First Post:
2024-03-22
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Potential Role of Sirtuins As Epigenetic Biomarkers of the Patient with Atherosclerosis or Calcific Aortic Stenosis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D050197', 'term': 'Atherosclerosis'}], 'ancestors': [{'id': 'D001161', 'term': 'Arteriosclerosis'}, {'id': 'D001157', 'term': 'Arterial Occlusive Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 3}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-10-19', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-03', 'completionDateStruct': {'date': '2026-10', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-03-07', 'studyFirstSubmitDate': '2024-03-22', 'studyFirstSubmitQcDate': '2024-03-22', 'lastUpdatePostDateStruct': {'date': '2025-03-11', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-03-29', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-10', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'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', 'timeFrame': '36 months'}], 'secondaryOutcomes': [{'measure': 'To evaluate the experimental results achieved in the clinical-diagnostic context', 'timeFrame': '36 months'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Atherosclerosis and Calcific Aortic Stenosis with and Without Diabetes']}, 'descriptionModule': {'briefSummary': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': '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', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients with atherosclerosis or calcific aortic stenosis with and without diabetes older than 18 years of either sex;\n* Patients without atherosclerosis undergoing surgical procedure for endocarditis;\n* Patients who will have signed informed consent\n\nExclusion Criteria:\n\n* Patients for whom biological material cannot be recovered for study purposes;\n* Patients who refuse to participate in the study'}, 'identificationModule': {'nctId': 'NCT06337227', 'briefTitle': 'Potential Role of Sirtuins As Epigenetic Biomarkers of the Patient with Atherosclerosis or Calcific Aortic Stenosis', 'organization': {'class': 'OTHER', 'fullName': 'IRCCS SYNLAB SDN'}, 'officialTitle': 'Potential Role of Sirtuins As Epigenetic Biomarkers for the Clinical Management of the Patient with Atherosclerosis or Calcific Aortic Stenosis', 'orgStudyIdInfo': {'id': '2/22'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'atherosclerosis and calcific aortic stenosis with diabetes patients', 'interventionNames': ['Diagnostic Test: lncRNA signature analyses']}, {'label': 'atherosclerosis and calcific aortic stenosis without diabetes patients', 'interventionNames': ['Diagnostic Test: lncRNA signature analyses']}, {'label': 'Patients without atherosclerosis undergoing surgical procedure for endocarditis', 'interventionNames': ['Diagnostic Test: lncRNA signature analyses']}], 'interventions': [{'name': 'lncRNA signature analyses', 'type': 'DIAGNOSTIC_TEST', 'description': 'Specific validation experiments will be performed by Real-Time PCR (C-reactive protein), Western Blot, flow cytometry and microscopy', 'armGroupLabels': ['Patients without atherosclerosis undergoing surgical procedure for endocarditis', 'atherosclerosis and calcific aortic stenosis with diabetes patients', 'atherosclerosis and calcific aortic stenosis without diabetes patients']}]}, 'contactsLocationsModule': {'locations': [{'zip': '80143', 'city': 'Naples', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Monica Franzese, PhD', 'role': 'CONTACT', 'email': 'direzionescientifica.irccssdn@synlab.it', 'phone': '+393334041413'}], 'facility': 'Irccs Synlab Sdn', 'geoPoint': {'lat': 40.85216, 'lon': 14.26811}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'IRCCS SYNLAB SDN', 'class': 'OTHER'}, 'collaborators': [{'name': 'Federico II University', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}