Ignite Creation Date:
2025-12-24 @ 4:15 PM
Ignite Modification Date:
2026-02-01 @ 11:57 PM
Study NCT ID:
NCT02818166
Status:
UNKNOWN
Last Update Posted:
2016-08-04
First Post:
2016-01-05
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Magnetic Resonance Imaging for Cerebral Embolization During Minimal Invasive Mitral Valve Surgery
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008944', 'term': 'Mitral Valve Insufficiency'}], 'ancestors': [{'id': 'D006349', 'term': 'Heart Valve Diseases'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['CARE_PROVIDER']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 80}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2014-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-08', 'completionDateStruct': {'date': '2017-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2016-08-02', 'studyFirstSubmitDate': '2016-01-05', 'studyFirstSubmitQcDate': '2016-06-24', 'lastUpdatePostDateStruct': {'date': '2016-08-04', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2016-06-29', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'MR microembolization', 'timeFrame': 'untill 3 days after surgical procedure', 'description': 'To determine the incidence of new lesions on pre-discharge MR in patients undergoing right mini-thoracotomy mitral valve surgery according to different aortic clamping techniques.'}, {'measure': 'Clinical events and MR outcome correlation', 'timeFrame': 'untill 3 days after surgical procedure', 'description': 'To assess the correlation between clinical neurological peri-procedural events (TIA, Stroke), cognitive / neuropsychological status and the occurrence of new lesions on pre-discharge MR.'}], 'secondaryOutcomes': [{'measure': 'Evolution of MR lesions', 'timeFrame': '3 month follow up', 'description': 'To assess the evolution of new cerebral ischemic lesions between pre-discharge MR and follow-up MR (3 months later)'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['magnetic resonance', 'right mini-thoracotomy'], 'conditions': ['Neurological Complications', 'Mitral Valve Insufficiency']}, 'referencesModule': {'references': [{'pmid': '28222779', 'type': 'DERIVED', 'citation': 'Barbero C, Ricci D, Cura Stura E, Pellegrini A, Marchetto G, ElQarra S, Boffini M, Passera R, Valentini MC, Rinaldi M. Magnetic resonance imaging for cerebral lesions during minimal invasive mitral valve surgery: study protocol for a randomized controlled trial. Trials. 2017 Feb 21;18(1):76. doi: 10.1186/s13063-017-1821-y.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to prospectively evaluate major and minor neurologic events in patients undergoing right mini-thoracotomy mitral valve surgery and to compare different aortic clamping techniques; specifically, the endoaortic balloon with retrograde perfusion (Endoreturn) and the transthoracic clamp with retrograde perfusion. Major neurologic events will be evaluate through standard neurologic evaluation; minor neurologic events will be evaluate through magnetic resonance (MR) assessment.\n\nThe first aim of the study is to determine the number and impact of microembolic events during right mini-thoracotomy mitral valve surgery on clinical neurological status and on MR evaluation. The investigators also aim to determine if different techniques of aortic clamping may impact on early outcome.\n\nStudy hypothesis: despite recent concerns arising about endoaortic balloon with retrograde perfusion, the investigators expect to show equivalence in term of safety and effectiveness of this technique compared with the transthoracic clamp in a selected population.', 'detailedDescription': 'The incidence of neurologic events in right mini-thoracotomy mitral valve surgery compared with that of conventional surgery is a controversial issue and has been extensively studied. In the meta-analysis published by Modi et al, equal occurrence of neurologic events between patients who underwent MIMVS and those who underwent a median sternotomy was found. Conversely, the Thoracic Surgeons Adult Cardiac database and the Cleveland Clinic group concluded that the risk of stroke is significantly higher in the less invasive group.\n\nMoreover, recent data have suggested that retrograde arterial perfusion, particularly in patients with severe arch/ascending aortic atherosclerosis, could be the source of the significant increase in the incidence of cerebral complications. The meta-analysis of Cheng, documents a 1.79 fold increase in the risk of stroke in the right thoracotomy group, but on subgroup analysis this appeared driven by a higher stroke risk in those studies reporting endoaortic balloon occlusion and not transthoracic clamping. Murzi et al. report a 4.28 fold increase in stroke risk with RAP in 1280 primary MIMVS patients. Grossi and colleagues show that the only significant risk factor for neurologic event was the use of retrograde perfusion in high-risk patients with aortic disease.\n\nThe purpose of this randomized blinded study is to prospectively evaluate major and minor neurologic events in patients undergoing right thoracotomy mitral valve surgery with retrograde perfusion and endoaortic balloon clamp (Endoreturn) or transthoracic clamp. Major neurologic events will be evaluate through standard neurologic evaluation; minor neurologic events will be evaluate through magnetic resonance assessment.\n\nMR evaluation will be performed by blinded radiologists. MR will be performed with a 3T system (Philips INGENIA 3T). The protocol includes conventional sequences for the morphological and quantitative assessment (3D-FLAIR, 3D-T1-TSE, DWI, T2-FFE) and non conventional sequences for the white matter microstructural evaluation (Diffusion Tensor Imaging - DTI with fractional anisotropy and mean diffusivity). No contrast enhanced will be used.\n\nPatients who have no contraindications will undergo cerebral MR before surgery as baseline assessment. Then, they will be randomized in one of the 2 groups.\n\nIf no contraindications arise in the postoperative period (eg definitive pacemaker implantation), patients will undergo cerebral MR before the discharge, to highlight the presence of new ischemic lesions, even clinically silent.\n\nAfter 6 months, patients who developed new ischemic lesions revealed by the post-operative cerebral MR will repeat a new MR to assess evolution of cerebral damage Neurologic assessment will be performed by blinded specialists of the Neurology Department.\n\nType of the study:\n\nSingle center randomized blinded study that will be performed at the University of Turin, Città della Salute e della Scienza Hospital and will include:\n\nCardiac Surgery department. Neuroradiology department.\n\nAims of the study:\n\nTo determine the incidence of new lesions on pre-discharge MR in patients undergoing right mini-thoracotomy mitral valve surgery according to different aortic clamping techniques.\n\nTo assess the correlation between clinical neurological peri-procedural events (TIA, Stroke), and the occurrence of new lesions on pre-discharge MR.\n\nTo assess the evolution of new cerebral ischemic lesions between pre-discharge MR and follow-up MR (more than 6 months later).\n\nTo the investigators knowledge this is the first randomized blinded study that will compare two right mini-thoracotomy techniques for mitral valve surgery on a selected population (without risk factors for neurological events) with MR.\n\nThe result of this study will be able to allow surgeons to choose the best and less dangerous method in case of mini-invasive operations. This could rapresent a fundamental step in confirming the efficacy and safety of mini-invasive approaches for mitral valve surgery and resulting, in addition, in the reduction of the costs of these procedures.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age between 18 and 80 years.\n* Indication for elective mitral valve surgery +/- tricuspid valve surgery through right mini-thoracotomy.\n* No contraindication for MR\n\nExclusion Criteria:\n\n* Neuro-cognitive diseases;\n* Peripheral vascular disease;\n* Atrial fibrillation;\n* PFO o interatrial defect;\n* Previous Stroke;\n* Autoimmune diseases;\n* Neoplastic diseases;\n* Migraine;\n* Celiac disease;\n* Alchool or drug abuse;\n* Contraindication for MR.'}, 'identificationModule': {'nctId': 'NCT02818166', 'briefTitle': 'Magnetic Resonance Imaging for Cerebral Embolization During Minimal Invasive Mitral Valve Surgery', 'organization': {'class': 'OTHER', 'fullName': 'University of Turin, Italy'}, 'officialTitle': 'Magnetic Resonance Neurological Evaluation After Right Mini-thoracotomy Mitral Valve Surgery: Trans-thoracic Versus Endoaortic Clamp', 'orgStudyIdInfo': {'id': 'Turin University'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Endoaortic Clamp', 'description': 'Right mini-thoracotomy mitral valve surgery with retrograde perfusion and endoaortic balloon clamp', 'interventionNames': ['Procedure: Mitral valve surgery']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Transthoracic Clamp', 'description': 'Right mini-thoracotomy mitral valve surgery with retrograde perfusion and transthoracic clamp.', 'interventionNames': ['Procedure: Mitral valve surgery']}], 'interventions': [{'name': 'Mitral valve surgery', 'type': 'PROCEDURE', 'description': 'Right mini-thoracotomy mitral valve replacement/repair.', 'armGroupLabels': ['Endoaortic Clamp', 'Transthoracic Clamp']}]}, 'contactsLocationsModule': {'locations': [{'zip': '10126', 'city': 'Turin', 'state': 'Italy', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Mauro Rinaldi, MD', 'role': 'CONTACT', 'email': 'mauro.rinaldi@unito.it', 'phone': '+390116335511'}, {'name': 'Cristina Barbero, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'University of Turin - Cardiothoracic Department', 'geoPoint': {'lat': 45.07049, 'lon': 7.68682}}], 'centralContacts': [{'name': 'Cristina Barbero, MD', 'role': 'CONTACT', 'email': 'cristina.barbero@unito.it', 'phone': '+390116335511'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'YES'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Turin, Italy', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Cardiothoracic Surgeon', 'investigatorFullName': 'Cristina Barbero', 'investigatorAffiliation': 'University of Turin, Italy'}}}}