Ignite Creation Date:
2025-12-25 @ 3:04 AM
Ignite Modification Date:
2025-12-26 @ 1:43 AM
Study NCT ID:
NCT05438433
Status:
COMPLETED
Last Update Posted:
2022-06-30
First Post:
2022-06-01
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Outcome of Preserved Mitral Valve Apparatus During Mitral Valve Replacement
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007511', 'term': 'Ischemia'}], 'ancestors': [{'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2016-08-01', 'size': 371846, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2022-06-05T13:25', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE', 'maskingDescription': 'All roles were unmasked'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'both groups of patients received surgical treatment parallel to each other.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 100}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-12-28', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-06', 'completionDateStruct': {'date': '2021-12-28', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-06-23', 'studyFirstSubmitDate': '2022-06-01', 'studyFirstSubmitQcDate': '2022-06-23', 'lastUpdatePostDateStruct': {'date': '2022-06-30', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-06-30', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-01-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Smoking index', 'timeFrame': 'One week before surgery(or during first clinical visit) .', 'description': 'Number of Packs every day X number of years of smoking= Pack.year,'}, {'measure': 'Age and gender for each participant', 'timeFrame': 'One week before surgery .', 'description': 'Males above 40 years and Females above 45 years need pre-operative coronary angio-graph'}, {'measure': 'For each participant: pathological:type of mitral valve lesion', 'timeFrame': 'Seven days before surgery .', 'description': 'severe stenosis with mitral area \\< 1 cm square, severe regurgitation, or mixed lesions'}, {'measure': 'For each participant: etiological :type of mitral valve lesion', 'timeFrame': 'Seven days before surgery .', 'description': 'Rheumatic: distorted thickened leaflets,thickened fibrosed chordae'}, {'measure': 'For each participant: etiological :type of mitral valve lesion', 'timeFrame': 'Seven days before surgery- echo-cardiograph.', 'description': 'Rheumatic: distorted thickened leaflets,thickened fibrosed chordae or ischemic incompetence'}, {'measure': 'For each participant:, assessing sub-valvular apparatus', 'timeFrame': 'One week before surgery. with Echo-cardiograph.', 'description': 'Thickened chordae, ruptured chordae, ischemia of papillary muscles or lateral ventricular wall.'}, {'measure': 'Abascal echo-cardiographic mitral valve score (Wilkins score)', 'timeFrame': 'One week before surgery.with Echo-cardiograph', 'description': ':if score is 8 or less it is good for balloon valvo-plasty, if \\> 8 surgery is recommended ( leaflet mobility, thickness and calcification. Fourthly, sub-valvular thickening., higher scores = more deterioration'}, {'measure': 'left ventricular wall motion abnormality', 'timeFrame': 'one week before surgery - with an echo-cardiograph', 'description': 'hypokinesia, Akinesia, Dyskinesia of certain segment(s)'}, {'measure': 'Number of participants with Signs of left ventricular dysfunction', 'timeFrame': 'seven days before surgery echo-cardiograph examination', 'description': 'low ejection fraction \\<52%, low stroke volume\\< 70 ml, low cardiac output \\<5 litres per minute'}, {'measure': 'Number of participants with pre-operative coronary artery disease', 'timeFrame': 'seven days before surgery, coronary angio-graph', 'description': 'Expected on clinical bases and .proved by Echo-cardiograph-findings'}, {'measure': 'Number of participants with pre-operative ischemic complications', 'timeFrame': 'seven days before surgery echo-cardiograph examination', 'description': 'left ventricular thrombi, septal and left ventricular wall thickness in mm .'}, {'measure': 'Assessment of any evolving new prosthetic valve dysfunction', 'timeFrame': 'intra-operative trans-esophageal echo-cardiograph examination', 'description': 'Left atrioventricular outflow stenosis, prosthetic dysfunction due to preservation of valve apparatus'}, {'measure': 'Change in post-operative left ventricular functions', 'timeFrame': '5 days post-operatively and end of 6th and 12 months after surgery with Echo-Cardiograph', 'description': ': Low Fractional Shortening \\< 28% , Ejection fraction \\< 40%,, increased left ventricular dimensions and volume'}, {'measure': 'Change of Prosthetic mitral valve functions', 'timeFrame': 'Monthly through study completion up to 12 months after surgery..... with Echo-cardiograph', 'description': 'Development of para-valvular leak or central jet of regurgitation or stuck valve by a thrombus'}], 'secondaryOutcomes': [{'measure': 'changes on Clinical examination', 'timeFrame': 'Monthly up to 12 months after surgery)', 'description': 'local and general Examination,: a new murmur, evolving heart failure'}, {'measure': 'Changes in Results of Prothrombin time, concentration and.International normalized ratio', 'timeFrame': '.Monthly through study completion up to 12 months.', 'description': 'Adjust dose of oral anticoagulant.( between double and half to three times the control) Dose usually ranges between 1 and 11 mg warfarin tablet daily.'}, {'measure': 'Mortality and Morbidity', 'timeFrame': 'Monthly through study completion up to 12 months.', 'description': 'cause of mortality, type of morbidity: wound infection, hypertrophied scar, Kiloid Formation'}]}, 'oversightModule': {'isUsExport': True, 'oversightHasDmc': True, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'keywords': [': Preservation of mitral apparatus ,', 'mitral valve replacement', 'Rheumatic valve disease and ischemia'], 'conditions': ['Diseases of Mitral Valves', 'Abnormality of Mitral Valve Annulus (Disorder)', 'Mitral Valve Replacement']}, 'descriptionModule': {'briefSummary': 'Are there differences in outcome of mitral valve replacement with preservation of mitral apparatus among rheumatic and/or ischemic mitral lesions?.\n\nMitral valve replacement with preservation of leaflets, and added coronary artery-bypass surgery, when indicated, is it a feasible and reproducible procedure?.\n\nThe study was designed to compare outcome after prosthetic mitral replacement with preservation of mitral apparatus for rheumatic valve disease with outcome of replacement for ischemic myocardium and mitral valve disease, The outcomes will be guided by clinical assessment. and echo-cardiograph.', 'detailedDescription': 'Objectives: The aim is to compare outcome of modified preservation of mitral valve apparatus during prosthetic mitral replacement for rheumatic versus myocardial ischemia \\&mitral valve disease.\n\nMethods ;This prospective cross-sectional comparative study will include 50 patients with isolated rheumatic mitral valve disease (group A) and 50 patients with mitral disease and myocardial ischemia (group B), surgery is expected to be performed between 2017 and 2020 at one center. All patients will have modified preservation of mitral apparatus during prosthetic mitral replacement. Additionally, group B patients will have bypass grafts to left anterior descending and/or posterior descending / right coronary artery. Data will be collected and analyzed.\n\nThe Institutional Review Board (IRB), Ethics Committee (EC)-approval and consent of each patient were obtained.\n\nCriteria for inclusion of patients and exclusion of others were determined according to the guide lines.\n\nStatistical analysis::\n\nQualitative variables and their association among both groups were studied by applying Chi-square test and Fisher Exact test. Quantitative variables among both groups were compared by applying independent samples t-test. P \\< 0.05 values mean statistically-significant results.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '30 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria::\n\nMitral stenosis (MS)\n\n* symptoms are severely limiting and cannot be managed with diuresis and heart rate control.\n\nMitral regurgitation(MR):\n\n\\* acute severe MR require surgical correction for hemo-dynamics and relief of symptoms .\n\nChronic primary mitral regurgitation:\n\n\\* rheumatic heart disease: replacement before irreversible changes occur can be curative.\n\nMixed Mitral Stenosis and Mitral Regurgitation:\n\n* If beta blockers and diuretics do not relieve symptoms, replacement should be performed only in patients who have severe limiting symptoms.\n* Myocardial ischemia associating or complicated with miral valve disease.\n\nExclusion criteria\n\n* Patients showing good response to medical therapy, and Cases complicated by:\n* ineffective endocarditis,\n* previous myocardial re-vascularization\n* ischemic ventricular septal defect,\n* left ventricular aneurysm,\n* Ruptured papillary muscles of mitral apparatus.'}, 'identificationModule': {'nctId': 'NCT05438433', 'acronym': 'EarlyOutcome', 'briefTitle': 'Outcome of Preserved Mitral Valve Apparatus During Mitral Valve Replacement', 'organization': {'class': 'OTHER', 'fullName': 'Suez Canal University'}, 'officialTitle': 'Outcome of Preservation of Mitral Valve Leaflets During Mitral Replacement', 'orgStudyIdInfo': {'id': '2796#'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'SHAM_COMPARATOR', 'label': 'Group A', 'description': '50 patients with isolated rheumatic mitral valve disease (group A)', 'interventionNames': ['Device: St.Jude bi leaflet prosthetic mitral valve to replace the diseased valve with preservation of both leaflets']}, {'type': 'OTHER', 'label': 'Group B', 'description': '50 patients with mitral disease and myocardial ischemia (group B)', 'interventionNames': ['Device: St.Jude bi leaflet prosthetic mitral valve to replace the diseased valve with preservation of both leaflets']}], 'interventions': [{'name': 'St.Jude bi leaflet prosthetic mitral valve to replace the diseased valve with preservation of both leaflets', 'type': 'DEVICE', 'otherNames': ['St.Jude bi leaflet prosthesis to replace diseased valve with preservation of leaflets with Myocardial re-vascularization', 'St.Jude prosthetic mitral replacement with preservation of valve apparatus and bypass grafts for associated coronary artery disease'], 'description': 'St.Jude prosthetic(FDA approved) mitral valve replacement with or without coronary artery bypass grafts', 'armGroupLabels': ['Group A', 'Group B']}]}, 'contactsLocationsModule': {'locations': [{'zip': '+064', 'city': 'Ismailia', 'country': 'Egypt', 'facility': 'Suez Canal University', 'geoPoint': {'lat': 30.60427, 'lon': 32.27225}}, {'zip': '002-064', 'city': 'Ismailia', 'country': 'Egypt', 'facility': 'Suez Canal University', 'geoPoint': {'lat': 30.60427, 'lon': 32.27225}}], 'overallOfficials': [{'name': 'Mohamed A. allaban, PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Suez Canal University, FOM- Research Ethics Committee'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'SAP', 'ICF', 'CSR'], 'timeFrame': 'Within 360 days', 'ipdSharing': 'YES', 'description': 'All authors contributed to the study conception and design. Material preparation, data collection and analysis were performed by H. D. Elayouty, H. S. Hassan and S.A. Elhafeez. The first draft of the manuscript was written by A. H.Elayouty and all authors commented on previous versions of the manuscript. All authors read and approved the final manuscript.', 'accessCriteria': 'h.dosoky@yahoo.com'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Suez Canal University', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Research Centre, Egypt', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Prof. of Cardio-thoracic Surgery', 'investigatorFullName': 'Hamdy Dosoky Ibraheem Elayouty', 'investigatorAffiliation': 'Suez Canal University'}}}}