Ignite Creation Date:
2025-12-24 @ 7:36 PM
Ignite Modification Date:
2026-01-01 @ 4:32 PM
Study NCT ID:
NCT04231903
Status:
COMPLETED
Last Update Posted:
2020-01-18
First Post:
2020-01-05
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Myocardial Protection in Minimally Invasive Mitral Valve Surgery
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008945', 'term': 'Mitral Valve Prolapse'}], 'ancestors': [{'id': 'D016127', 'term': 'Heart Valve Prolapse'}, {'id': 'D006349', 'term': 'Heart Valve Diseases'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 116}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-06-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-01', 'completionDateStruct': {'date': '2018-12-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-01-15', 'studyFirstSubmitDate': '2020-01-05', 'studyFirstSubmitQcDate': '2020-01-15', 'lastUpdatePostDateStruct': {'date': '2020-01-18', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-01-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-06-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'cTn-T levels immediately after surgery', 'timeFrame': 'Immediately after surgery', 'description': 'Myocardial protection was assessed through cardiac Troponin T (cTn-T) blood levels and compared between the 2 groups of aortic clamping'}, {'measure': 'CK-MB levels immediately after surgery', 'timeFrame': 'Immediately after the surgery', 'description': 'Myocardial protection was assessed through creatinine kinase-myocardial band (CK-MB) blood levels after right mini-thoracotomy mitral valve surgery and compared between the 2 groups of aortic clamping'}, {'measure': 'cTn-T levels 6h', 'timeFrame': 'hour 6 after surgery', 'description': 'Myocardial protection was assessed through cardiac Troponin T (cTn-T) blood levels and compared between the 2 groups of aortic clamping'}, {'measure': 'CK-MB levels 6h', 'timeFrame': 'hour 6 after surgery', 'description': 'Myocardial protection was assessed through creatinine kinase-myocardial band (CK-MB) blood levels after right mini-thoracotomy mitral valve surgery and compared between the 2 groups of aortic clamping'}, {'measure': 'cTn-T levels 12h', 'timeFrame': 'hour 12 after surgery', 'description': 'Myocardial protection was assessed through cardiac Troponin T (cTn-T) blood levels and compared between the 2 groups of aortic clamping'}, {'measure': 'CK-MB levels 12h', 'timeFrame': 'hour 12 after surgery', 'description': '(CK-MB) blood levels after right mini-thoracotomy mitral valve surgery and compared between the 2 groups of aortic clamping'}, {'measure': 'cTn-T levels 24h', 'timeFrame': 'hour 24 after surgery', 'description': 'Myocardial protection was assessed through cardiac Troponin T (cTn-T) blood levels and compared between the 2 groups of aortic clamping'}, {'measure': 'CK-MB levels 24h', 'timeFrame': 'hour 24 after surgery', 'description': 'Myocardial protection was assessed through cardiac Troponin T (cTn-T) blood levels and compared between the 2 groups of aortic clamping'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Myocardial Protection', 'Minimally Invasive Surgery', 'Mitral Valve Prolapse']}, 'descriptionModule': {'briefSummary': 'Perfusion strategies and aortic clamping techniques for right mini-thoracotomy mitral valve (MV) surgery have evolved over time and remarkable short- and long-term results have been re-ported. However, some concerns have emerged about the adequacy of myocardial protection dur-ing the minimally invasive approach and about the role of aortic clamping strategies in this contest.\n\nAim of this study was to compare the efficacy, in terms of myocardial protection, of the en-do-aortic clamp (EAC) versus the trans-thoracic aortic clamp (TTC) in patients undergoing right mini-thoracotomy MV repair.\n\nA single center, prospective observational study was performed between June 2014 to June 2018 on patients undergoing right mini-thoracotomy MV repair with retrograde arterial perfusion and EAC or TTC. The selection of one setting in respect to the other was patient orientated. Myocardial protection was assessed through creatinine kinase-myocardial band (CK-MB) and cardiac Troponin T (cTn-T) blood levels immediately after the surgical procedure and at 6, 12, and 24 hours and compared between the two groups.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'All comers at our Deparment with diagnosis of mitral valve disease with surgical indication for mitral valve repair through the right mini-thoracotomy approach and retrograde arterial perfusion.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Surgical indication for mitral valve repair.\n* Right mini-thoracotomy approach.\n* Retrograde arterial perfusion.\n\nExclusion Criteria:\n\n* Age more than 75 years.\n* Cardiac ejection fraction lower than 40%.\n* Previous cardiac surgery procedures for coronary artery bypass graft.\n* Any degree of coronary artery disease.\n* Severe peripheral vascular disease.\n* Concomitant procedures for atrial fibrillation ablation.'}, 'identificationModule': {'nctId': 'NCT04231903', 'briefTitle': 'Myocardial Protection in Minimally Invasive Mitral Valve Surgery', 'organization': {'class': 'OTHER', 'fullName': 'University of Turin, Italy'}, 'officialTitle': 'Endo-aortic Versus Trans-thoracic Clamping in Right Mini-thoracotomy Mitral Valve Repair: Outcome on Myocardial Pro-tection', 'orgStudyIdInfo': {'id': '0063123'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'EAC', 'description': 'Patients undergoing surgery endo-aortic clamp.', 'interventionNames': ['Device: Aortic clamp']}, {'label': 'TTC', 'description': 'Patients undergoing surgery through trans-thoracic aortic clamp.', 'interventionNames': ['Device: Aortic clamp']}], 'interventions': [{'name': 'Aortic clamp', 'type': 'DEVICE', 'description': 'In the firs group an endo-aortic clamp is used and in the second group an external clamp is used.', 'armGroupLabels': ['EAC', 'TTC']}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Turin, Italy', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MD, PhD, Cardio-thoracic Surgeon, Principal Investigator', 'investigatorFullName': 'Cristina Barbero', 'investigatorAffiliation': 'University of Turin, Italy'}}}}