Ignite Creation Date:
2025-12-24 @ 10:33 PM
Ignite Modification Date:
2025-12-30 @ 7:10 AM
Study NCT ID:
NCT04916535
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-07-15
First Post:
2021-06-03
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Prospective Multicenter Study on Mitral Annular Disjunction
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'Observational cohort prospective multicenter study on patients with MAD'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 249}}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2021-06-03', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-07', 'completionDateStruct': {'date': '2030-07-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-07-10', 'studyFirstSubmitDate': '2021-06-03', 'studyFirstSubmitQcDate': '2021-06-03', 'lastUpdatePostDateStruct': {'date': '2025-07-15', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-06-07', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-07-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Pathological findings associated with MAD', 'timeFrame': '3 months', 'description': 'Percentage of subjects with MAD whom deeper analysis with cardiological visit, electrocardiogram (ECG), 24-hour ECG Holter monitoring and cardiac magnetic resonance (CMR) identifies pathological findings. Pathological findings are defined as follows: -T wave inversion in inferolateral leads at ECG\n\n* frequent premature ventricular complexes (\\>1000/24h)\n* non-sustained ventricular arrythmias\n* sustained ventricular arrythmias\n* severe mitral regurgitation\n* myocardial fibrosis with a non-ischemic pattern, especially of papillary muscles and inferolateral wall. The primary endpoint will be considered achieved if at least one of the above mentioned paramentrs will be found in the patient'}], 'secondaryOutcomes': [{'measure': 'surgery for mitral valve', 'timeFrame': '5 years', 'description': 'occurrence of mitral surgery'}, {'measure': 'sudden cardiac death', 'timeFrame': '5 years', 'description': 'occurrence of sudden cardiac death'}, {'measure': 'aborted cardiac arrest', 'timeFrame': '5 years', 'description': 'occurrence of aborted cardiac arrest'}, {'measure': 'ventricular arrhythmia', 'timeFrame': '5 years', 'description': 'occurrence of non-sustained and/or sustained ventricular tachycardia'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['mitral annular disjunction'], 'conditions': ['Mitral Valve Disease']}, 'descriptionModule': {'briefSummary': 'Observational cohort prospective multicenter study on patients with mitral annular disjunction (MAD). MAD is defined as a separation (≥1 mm) between the atrial wall-mitral valvular junction and the left ventricular free wall during end-systole', 'detailedDescription': 'Mitral annular disjunction (MAD) is a structural abnormality of the mitral annulus, defined as a separation (≥1 mm) between the atrial wall-mitral valvular junction and the left ventricular free wall during end-systole. This abnormality is significantly associated with the presence of mitral valve prolapse (MVP), but it can also be observed in normal hearts. MAD-related hypermobility of the mitral apparatus and the consequent posterior systolic curling determine a mechanical stress of the infero-basal wall and papillary muscle. This phenomenon leads to myocardial hypertrophy and fibrosis, creating an arrhythmogenic substrate and a source of electrical instability. For this reason, the analysis of left ventricle by cardiac magnetic resonance plays a pivotal role in the identification of predictors of fatal arrhythmic events, such as sudden cardiac death (SCD). Taking into account that MAD could be present without MVP, some studies analyzed the association between MAD and arrhythmic events. They showed that MAD itself is a risk marker of electrical instability supporting the existence of an emerging clinical entity: the MAD arrhythmic syndrome. An in deep analysis of MAD patients and their characteristics in terms of EKG, types of arrhythmia, echocardiographic parameters and cardiac magnetic resonance (CMR) data and long-term events is lacking.\n\nThe present study is ideated and conducted to fill this gap and collect information regarding management and outcome of patients with MAD'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion criteria:\n\n* Subject aged ≥18 years and \\<65 years\n* Evidence of MAD during routine echocardiography clinically indicated by treating physician for any reason\n* Written informed consent\n\nExclusion criteria:\n\n• Patient's refusal"}, 'identificationModule': {'nctId': 'NCT04916535', 'acronym': 'MAD-NesS', 'briefTitle': 'Prospective Multicenter Study on Mitral Annular Disjunction', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital of Ferrara'}, 'officialTitle': 'Observational Cohort Prospective Multicenter Study on Mitral Annular Disjunction (MAD) - MAD multiceNter Study (MAD-NesS)', 'orgStudyIdInfo': {'id': '367/2021/Oss/AOUFe'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'diagnostic flow', 'description': 'all patients with MAD as assessed during routine transthoracic echocardiography will undergo to the following further exams: i) 12-lead electrocardiogram (ECG), ii) 24-hour ECG monitoring, iii) cardiac magnetic resonance imaging (CMR), iv) cardiological visit', 'interventionNames': ['Other: diagnostic flow']}], 'interventions': [{'name': 'diagnostic flow', 'type': 'OTHER', 'description': 'exams to estimate the risk of adverse events in patients with MAD', 'armGroupLabels': ['diagnostic flow']}]}, 'contactsLocationsModule': {'locations': [{'zip': '44124', 'city': 'Ferrara', 'state': 'Ferrara', 'country': 'Italy', 'facility': 'University Hospital of Ferrara', 'geoPoint': {'lat': 44.83804, 'lon': 11.62057}}, {'city': 'Bologna', 'country': 'Italy', 'facility': 'Cardiology Unit', 'geoPoint': {'lat': 44.49381, 'lon': 11.33875}}, {'city': 'Forlì', 'country': 'Italy', 'facility': 'Morgagni Hospital', 'geoPoint': {'lat': 44.22177, 'lon': 12.04144}}, {'city': 'Palermo', 'country': 'Italy', 'facility': 'Cardiology Unit', 'geoPoint': {'lat': 38.1166, 'lon': 13.3636}}, {'city': 'Ravenna', 'country': 'Italy', 'facility': 'Santa Maria delle Croci Hospital', 'geoPoint': {'lat': 44.41344, 'lon': 12.20121}}, {'city': 'Rimini', 'country': 'Italy', 'facility': 'Cardiology Unit', 'geoPoint': {'lat': 44.05755, 'lon': 12.56528}}, {'city': 'Trieste', 'country': 'Italy', 'facility': 'University Hospital fo Trieste', 'geoPoint': {'lat': 45.64953, 'lon': 13.77678}}], 'overallOfficials': [{'name': 'Elisabetta Tonet, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University Hospital of Ferrara'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital of Ferrara', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Full Professor Cardiologist', 'investigatorFullName': 'Gianluca Campo', 'investigatorAffiliation': 'University Hospital of Ferrara'}}}}