Ignite Creation Date:
2025-12-25 @ 3:44 AM
Ignite Modification Date:
2025-12-26 @ 2:30 AM
Study NCT ID:
NCT06678802
Status:
RECRUITING
Last Update Posted:
2024-11-07
First Post:
2024-11-06
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
SNORD3A IN ISCHEMIC HEART DISEASE AND HEART FAILURE
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D017202', 'term': 'Myocardial Ischemia'}, {'id': 'D006333', 'term': 'Heart Failure'}], 'ancestors': [{'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D001800', 'term': 'Blood Specimen Collection'}], 'ancestors': [{'id': 'D013048', 'term': 'Specimen Handling'}, {'id': 'D019411', 'term': 'Clinical Laboratory Techniques'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D011677', 'term': 'Punctures'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}, {'id': 'D008919', 'term': 'Investigative Techniques'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 450}, 'targetDuration': '6 Months', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-03-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-03', 'completionDateStruct': {'date': '2026-02-28', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-11-06', 'studyFirstSubmitDate': '2024-11-06', 'studyFirstSubmitQcDate': '2024-11-06', 'lastUpdatePostDateStruct': {'date': '2024-11-07', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-11-07', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-08-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Left ventricular ejection fraction', 'timeFrame': '0, 1 month, 6 months'}, {'measure': 'NT-pro-BNP levels', 'timeFrame': '0, 1 month, 6 months'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Ischemic Heart Disease', 'Heart Failure']}, 'descriptionModule': {'briefSummary': 'This is a prospective, non-randomized, single center, open label clinical study enrolling patients affected by 1) chronic ischemic heart disease with evidence or suspect significant myocardial ischemia (group 1, CCS) or 2) acute coronary syndromes (group 2, ACS), both undergoing coronary angiography and eventually coronary revascularization at the Department of Scienze Cardiovascolari, Diagnostica per Immagini ed Emergenze Cardiovascolari of Federico II University Hospital, Naples, Italy. Age and sex-matched healthy volunteers without known ischemic heart disease (group 3, Ctr) will also be included as a control group. At enrollment (time 0), and after 48 hours (time 48 h), 1 month (time 1mo) and 6 month-follow-up visits (time 6 mo), clinical evaluation, ECG, trans-thoracic echocardiography and blood sampling will be performed, to isolate peripheral blood mononuclear cells (PBMC) and perform standard blood tests. The enrolment phase will last 24 months, and will likely involve 450 patients distributed as follows, according to the number of patients annually referring to our University\n\nHospital:\n\n1. Group 1, n= 200 patients with chronic ischemic heart disease undergoing coronary angiography and eventually coronary revascularization;\n2. Group 2, n= 200 patients with ACS undergoing coronary angiography and eventually coronary revascularization ;\n3. Group 3, n= 50, healthy volunteers.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'This is a prospective, non-randomized, single center, open label clinical study enrolling patients affected by 1) chronic ischemic heart disease with evidence or suspect significant myocardial ischemia (group 1, CCS) or 2) acute coronary syndromes (group 2, ACS), both undergoing coronary angiography and eventually coronary revascularization at the Department of Scienze Cardiovascolari, Diagnostica per Immagini ed Emergenze Cardiovascolari of Federico II University Hospital, Naples, Italy. Age and sex-matched healthy volunteers without known ischemic heart disease (group 3, Ctr) will also be included as a control group. At enrollment (time 0), and after 48 hours (time 48 h), 1 month (time 1mo) and 6 month-follow-up visits (time 6 mo), clinical evaluation, ECG, trans-thoracic echocardiography and blood sampling will be performed, to isolate peripheral blood mononuclear cells (PBMC) and perform standard blood tests.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\nGroup 1:\n\nHistory (\\> 6 months) of ischemic heart disease (prior myocardial infarction, prior percutaneous coronary intervention, prior surgical revascularization) and clinical or imaging evidence of chronic moderate or severe myocardial ischemia\n\nGroup 2:\n\nPatients with acute coronary syndromes at presentation including ST-elevation myocardial infarction, Non-ST elevation myocardial infarction, and unstable angina.\n\nGroup 3:\n\nHealthy volunteers with no prior history of ischemic heart disease or clinical/imaging evidence of myocardial ischemia.\n\nExclusion Criteria:\n\nPatients unwilling to provide informed consent to participate to the study\n\n* Concomitant primary cardiomyopathies or hemodynamically significant heart valve disease\n* Treatment with cancer or antibiotic therapies affecting ribosomal structure or function.'}, 'identificationModule': {'nctId': 'NCT06678802', 'acronym': 'SENSITISE', 'briefTitle': 'SNORD3A IN ISCHEMIC HEART DISEASE AND HEART FAILURE', 'organization': {'class': 'OTHER', 'fullName': 'Federico II University'}, 'officialTitle': 'ROLE OF CIRCULATING SMALL NUCLEOLAR RNA SNORD3A IN ISCHEMIC HEART DISEASE AND HEART FAILURE', 'orgStudyIdInfo': {'id': '273/2023'}}, 'armsInterventionsModule': {'armGroups': [{'label': '1 - Chronic ischemic heart disease', 'interventionNames': ['Other: Blood sampling']}, {'label': '2 - Acute coronary syndromes', 'interventionNames': ['Other: Blood sampling']}, {'label': '3 - Healthy volunteers', 'interventionNames': ['Other: Blood sampling']}], 'interventions': [{'name': 'Blood sampling', 'type': 'OTHER', 'description': 'blood sampling from peripheral vein', 'armGroupLabels': ['1 - Chronic ischemic heart disease', '2 - Acute coronary syndromes', '3 - Healthy volunteers']}]}, 'contactsLocationsModule': {'locations': [{'zip': '80131', 'city': 'Naples', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Cinzia Perrino', 'role': 'CONTACT'}], 'facility': 'Federico II University Hospital', 'geoPoint': {'lat': 40.85216, 'lon': 14.26811}}], 'centralContacts': [{'name': 'Cinzia Perrino, MD PhD', 'role': 'CONTACT', 'email': 'perrino@unina.it', 'phone': '00390817462223'}, {'name': 'Giovanni Esposito', 'role': 'CONTACT', 'email': 'cardiologiafedericoii@gmail.com', 'phone': '00390817462223'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Federico II University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor, Director', 'investigatorFullName': 'Giovanni Esposito', 'investigatorAffiliation': 'Federico II University'}}}}