Ignite Creation Date:
2025-12-25 @ 1:26 AM
Ignite Modification Date:
2026-01-07 @ 1:21 AM
Study NCT ID:
NCT05523193
Status:
UNKNOWN
Last Update Posted:
2022-08-31
First Post:
2022-08-25
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Valvular Heart Disease in Jiangxi Province
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006349', 'term': 'Heart Valve Diseases'}, {'id': 'D000074822', 'term': 'Treatment Adherence and Compliance'}], 'ancestors': [{'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D015438', 'term': 'Health Behavior'}, {'id': 'D001519', 'term': 'Behavior'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2021-12-01', 'size': 491099, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2022-08-23T23:03', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITHOUT_DNA', 'description': 'Collect blood samples, tissues and body fluids according to the requirements of the sample bank'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 1052}, 'targetDuration': '2 Years', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2022-08-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-08', 'completionDateStruct': {'date': '2024-08-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-08-29', 'studyFirstSubmitDate': '2022-08-25', 'studyFirstSubmitQcDate': '2022-08-29', 'lastUpdatePostDateStruct': {'date': '2022-08-31', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-08-31', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-08-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Primary endpoints', 'timeFrame': '1 year after surgery or treatment', 'description': 'all-cause mortality, disabling stroke, and incidence of cardiogenic stroke, permanent pacemaker implantation rate, and moderate or greater valve regurgitation at 1 year after surgery or discharge from treatment'}], 'secondaryOutcomes': [{'measure': 'All-cause mortality', 'timeFrame': 'surgery or 30 days after treatment', 'description': 'Including cardiac death and non-cardiac death'}, {'measure': 'incidence of stroke', 'timeFrame': '30 days after discharge from hospital after surgery or treatment', 'description': 'The incidence of stroke 30 days after discharge from hospital after surgery or treatment'}, {'measure': 'rate of permanent pacemaker implantation', 'timeFrame': 'surgery or 30 days after treatment', 'description': 'The rate of permanent pacemaker implantation after surgery or 30 days after treatment'}, {'measure': 'Moderate or higher valvular regurgitation', 'timeFrame': 'immediately after the surgery or 30 days after discharge', 'description': 'Moderate or higher valvular regurgitation after surgery or 30 days after discharge'}, {'measure': 'Readmission rates for aortic stenosis and/or valve implantation-related complications', 'timeFrame': '30 days and 1 year after surgery or treatment', 'description': 'Readmission rates for aortic stenosis and/or valve implantation-related complications at 30 days and 1 year after surgery or treatment'}, {'measure': 'The incidence of intraoperative temporary valve size replacement', 'timeFrame': 'intraoperative', 'description': 'including increasing or decreasing valve size'}, {'measure': 'The incidence of abnormal valve position', 'timeFrame': 'during operation', 'description': 'including valve displacement, valve embolism, and valve ectopic release'}, {'measure': 'The incidence of implantation of two or more valves', 'timeFrame': 'during aortic valve replacement', 'description': 'The incidence of implantation of two or more valves during aortic valve replacement'}, {'measure': 'The Barthel index', 'timeFrame': '30 days and 1 year after surgery or treatment', 'description': 'The Barthel index was used to evaluate the health status of the subjects'}, {'measure': 'NYHA classification', 'timeFrame': '30 days and 1 year after discharge after surgery or treatment', 'description': 'NYHA classification at 30 days and 1 year after discharge after surgery or treatment'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Valvular Heart Disease', 'Valvular regurgitation', 'Valvular stenosis', 'TAVI'], 'conditions': ['Valvular Heart Disease', 'Treatment Adherence and Compliance']}, 'referencesModule': {'references': [{'pmid': '23547127', 'type': 'RESULT', 'citation': 'Cary T, Pearce J. Aortic stenosis: pathophysiology, diagnosis, and medical management of nonsurgical patients. Crit Care Nurse. 2013 Apr;33(2):58-72. doi: 10.4037/ccn2013820.'}, {'pmid': '27582763', 'type': 'RESULT', 'citation': 'Carita P, Coppola G, Novo G, Caccamo G, Guglielmo M, Balasus F, Novo S, Castrovinci S, Moscarelli M, Fattouch K, Corrado E. Aortic stenosis: insights on pathogenesis and clinical implications. J Geriatr Cardiol. 2016 Sep;13(6):489-98. doi: 10.11909/j.issn.1671-5411.2016.06.001.'}, {'pmid': '23062541', 'type': 'RESULT', 'citation': 'Dweck MR, Boon NA, Newby DE. Calcific aortic stenosis: a disease of the valve and the myocardium. J Am Coll Cardiol. 2012 Nov 6;60(19):1854-63. doi: 10.1016/j.jacc.2012.02.093. Epub 2012 Oct 10.'}, {'pmid': '26432749', 'type': 'RESULT', 'citation': 'Sathyamurthy I, Alex S. Calcific aortic valve disease: is it another face of atherosclerosis? Indian Heart J. 2015 Sep-Oct;67(5):503-6. doi: 10.1016/j.ihj.2015.07.033. Epub 2015 Aug 21.'}, {'pmid': '10814642', 'type': 'RESULT', 'citation': 'Soler-Soler J, Galve E. Worldwide perspective of valve disease. Heart. 2000 Jun;83(6):721-5. doi: 10.1136/heart.83.6.721. No abstract available.'}]}, 'descriptionModule': {'briefSummary': 'Study Title: A real-world study of valvular heart disease in Jiangxi Province\n\nResearch Objectives:\n\n① Main objectives: To examine the current incidence of valvular heart disease in Jiangxi Province, to establish a "Formal treatment model" for patients with valvular heart disease, and to manage the collection of diagnostic, therapeutic and prognostic data on patients.\n\n② Secondary objective: To investigate the composite of all-cause mortality, disabling stroke, permanent pacemaker implantation, and moderate or greater valve regurgitation in the "Formal treatment model" group and the "Conventional treatment model" group. The Conventional group was matched to patients who were not in the " Formal treatment model " during the same period.\n\nDesign type: a prospective, observational, real-world study (at least 1.5 years). No pre-established fixed treatment protocols, only a Formal treatment model,with all treatment choices made entirely by clinicians following relevant textbooks, expert consensus on clinical guidelines, and based on the patient\'s condition.\n\nSubjects: All patients with moderate to severe heart valve disease were collected from the Second Affiliated Hospital of Nanchang University and hospitals at all levels in Jiangxi Province from September 2022 to September 2023.', 'detailedDescription': 'Summary of Research Protocol:\n\nStudy Title: A Real World Study of Valvular Heart Disease in Jiangxi Province\n\nResearch Objectives:\n\n① Main objectives: To examine the current incidence of valvular heart disease in Jiangxi Province, to establish a "Formal treatment model" for patients with valvular heart disease, and to manage the collection of diagnostic, therapeutic and prognostic data on patients.\n\n② Secondary objective: To investigate the composite of all-cause mortality, disabling stroke, permanent pacemaker implantation, and moderate or greater valve regurgitation in the "Formal treatment model" group and the "Conventional treatment model" group. The Conventional group was matched to patients who were not in the " Formal treatment model " during the same period.\n\nDesign type: a prospective, observational, real-world study (at least 1.5 years). No pre-established fixed treatment protocols, only a Formal treatment model,with all treatment choices made entirely by clinicians following relevant textbooks, expert consensus on clinical guidelines, and based on the patient\'s condition.\n\nSubjects: All patients with moderate to severe heart valve disease were collected from the Second Affiliated Hospital of Nanchang University and hospitals at all levels in Jiangxi Province from September 2022 to September 2023.\n\nFormal treatment model group: Patients who agree and accept the surgical treatment recommendation (including medical and surgical treatment) enter the formal treatment model group.\n\nThose who have received any of the following treatments (including but not limited to) as recommended by the standardized treatment process are considered to have received the standardized treatment, otherwise, they have not.\n\n1. Surgical procedures: valve repair or replacement, left auricular ligation, left auricular clip.\n2. Internal surgery: transcatheter valve replacement, radiofrequency ablation of atrial fibrillation, and left heart ear occlusion.\n\nConventional treatment model group: Patients who do not agree to enter the Formal treatment model group will automatically enter the Conventional treatment model group.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'All patients with moderate to severe heart valve disease were collected from the Second Affiliated Hospital of Nanchang University and hospitals at all levels in Jiangxi Province from September 2022 to September 2023.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* All moderate-to-severe heart valve disease, including aortic, mitral, and tricuspid valves;\n* Comply with the ESC/EACTS Guidelines for the Management of Valvular Heart Disease (2021) indications for surgery for valvular heart disease;\n* Understand and voluntarily sign the informed consent form\n\nExclusion Criteria:\n\n* those with severe mental disorders and unable to express their will;\n* those with obvious other abnormal signs, laboratory tests and clinical diseases that, in the judgment of the investigator, make them unsuitable for participation in the study;\n* those who, in the judgment of the investigator, are unable to complete long-term follow-up.'}, 'identificationModule': {'nctId': 'NCT05523193', 'acronym': 'JXVD', 'briefTitle': 'Valvular Heart Disease in Jiangxi Province', 'organization': {'class': 'OTHER', 'fullName': 'Second Affiliated Hospital of Nanchang University'}, 'officialTitle': 'A Real World Study of Valvular Heart Disease in Jiangxi Province', 'orgStudyIdInfo': {'id': '2022-07'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Treatment group', 'description': 'Treatment group (Formal treatment model group): Patients who agree and accept the surgical treatment recommendation (including medical and surgical treatment) enter the formal treatment model group.\n\nThose who have received any of the following treatments (including but not limited to) as recommended by the standardized treatment process are considered to have received the standardized treatment, otherwise, they have not.\n\n1. Surgical procedures: valve repair or replacement, left auricular ligation, left auricular clip.\n2. Internal surgery: transcatheter valve replacement, radiofrequency ablation of atrial fibrillation, and left heart ear occlusion.', 'interventionNames': ['Other: Formal treatment model']}, {'label': 'Control group', 'description': 'Control group（Conventional treatment model group）:Patients who do not agree to enter the Formal treatment model group will automatically enter the Conventional treatment model group.'}], 'interventions': [{'name': 'Formal treatment model', 'type': 'OTHER', 'description': 'Formal treatment model , no further surgery or minimally invasive treatment was performed', 'armGroupLabels': ['Treatment group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '330000', 'city': 'Nanchang', 'state': 'Jiangxi', 'country': 'China', 'facility': 'The Second Affiliated Hospital of Nanchang University', 'geoPoint': {'lat': 28.68396, 'lon': 115.85306}}], 'overallOfficials': [{'name': 'Yanqing Wu, President', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Second Affiliated Hospital of Nanchang University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Xiao Huang', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Xiao Huang', 'investigatorAffiliation': 'Second Affiliated Hospital of Nanchang University'}}}}