Ignite Creation Date:
2025-12-24 @ 11:57 PM
Ignite Modification Date:
2025-12-30 @ 11:44 AM
Study NCT ID:
NCT03821051
Status:
RECRUITING
Last Update Posted:
2019-01-29
First Post:
2019-01-27
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
China Structural Ventricular Arrhythmias Registry
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D019571', 'term': 'Arrhythmogenic Right Ventricular Dysplasia'}, {'id': 'D002311', 'term': 'Cardiomyopathy, Dilated'}, {'id': 'D002312', 'term': 'Cardiomyopathy, Hypertrophic'}], 'ancestors': [{'id': 'D006330', 'term': 'Heart Defects, Congenital'}, {'id': 'D018376', 'term': 'Cardiovascular Abnormalities'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D009202', 'term': 'Cardiomyopathies'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D000013', 'term': 'Congenital Abnormalities'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}, {'id': 'D006332', 'term': 'Cardiomegaly'}, {'id': 'D000083083', 'term': 'Laminopathies'}, {'id': 'D030342', 'term': 'Genetic Diseases, Inborn'}, {'id': 'D001020', 'term': 'Aortic Stenosis, Subvalvular'}, {'id': 'D001024', 'term': 'Aortic Valve Stenosis'}, {'id': 'D000082862', 'term': 'Aortic Valve Disease'}, {'id': 'D006349', 'term': 'Heart Valve Diseases'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'blood sample will be collected from enrolled participants to detect biomarkers, like genes, inflammatory factors ,etc.'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 2000}, 'targetDuration': '5 Years', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2017-10-24', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-10', 'completionDateStruct': {'date': '2027-10-24', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2019-01-27', 'studyFirstSubmitDate': '2019-01-27', 'studyFirstSubmitQcDate': '2019-01-27', 'lastUpdatePostDateStruct': {'date': '2019-01-29', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-01-29', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-10-24', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'sustained tachycardia/ ventricular fibrillation or sudden cardiac death', 'timeFrame': '5 years', 'description': 'event of sustained ventricular tachycardia/ ventricular fibrillation or sudden cardiac death'}], 'secondaryOutcomes': [{'measure': 'episodes of arrhythmia', 'timeFrame': '5 years', 'description': 'record: type of arrhythmia, the amount of episodes, duration, unstable hemodynamics，treatment，'}, {'measure': 'all-cause death', 'timeFrame': '5 years', 'description': 'exclude accidents, like trauma, drowning.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['structural ventricular arrythmia', 'ischemic cardiomyopathy', 'arrhythmogenic right ventricular cardiomyopathy', 'dilated cardiomyopathy', 'hypertrophic cardiomyopathy', 'risk stratification'], 'conditions': ['Ventricular Arrythmia']}, 'descriptionModule': {'briefSummary': 'This is an observational, prospective, multi-center registry ,aiming at building a risk stratification for malignant structural ventricular arrhythmias. 2000 participants will be recruited from 10 centers in China,with clinical data to be abstracted from medical records ,and blood samples to be collected for finding promising risk indicators.The follow-up should be made every 6 mouths.', 'detailedDescription': 'In China, the prevalence and risk factors of malignant ventricular arrhythmias remain unclear. In addition ,the mainstream treatment relies on implantable devices and medication.China Malignant Ventricular Arrhythmias Study is a nation-wide complex consisting of several interrelated studies, with the aim of building a risk stratification as well as a efficient and economic strategy for early prevention and treatment.\n\nStructural Ventricular Arrhythmias Registry, as a part of China Malignant Ventricular Arrhythmias Study, is an observational, prospective, multi-center registry, aiming at building a risk stratification for malignant structural ventricular arrhythmias. 2000 patients with definitive diagnosis will be recruited consecutively from 10 major arrhythmia centers distributed in 6 areas in China. At study entry, participants will be interviewed and asked to sign the informed consent. Demographic characteristics, medical history, clinical features, laboratory tests, imaging pictures, medications, procedures, and in-hospital outcomes of patients will be abstracted from medical records by well trained staffs .At the same time, blood samples will be collected to detect biological markers, like genes, inflammatory factors ,etc. Once enrolled, the participants will receive follow up every 6 mouths about condition of arrhythmia, medication, clinical events, etc.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'In 10 major arrhythmia centers distributed in 6 areas in China, 2000 patients satisfying the inclusion criteria will be enrolled consecutively.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* diagnosed as ventricular arrhythmia resulted by structural heart diseases, including ischemic cardiomyopathy, arrhythmogenic right ventricular cardiomyopathy, dilated cardiomyopathy, hypertrophic cardiomyopathy, etc.\n\nExclusion Criteria:\n\n* none'}, 'identificationModule': {'nctId': 'NCT03821051', 'briefTitle': 'China Structural Ventricular Arrhythmias Registry', 'organization': {'class': 'OTHER_GOV', 'fullName': 'China National Center for Cardiovascular Diseases'}, 'officialTitle': 'China Structural Ventricular Arrhythmias Registry, a Multicenter，Observational and Prospective Study.', 'orgStudyIdInfo': {'id': '2017-950-1'}}, 'contactsLocationsModule': {'locations': [{'zip': '100037', 'city': 'Beijing', 'state': 'Beijing Municipality', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Yan Yao, MD, PhD', 'role': 'CONTACT', 'email': 'ianyao@263.net.cn', 'phone': '+86-13901121319'}, {'name': 'Shangyu Liu, MD', 'role': 'CONTACT', 'email': 'liushangyu_fw@163.com', 'phone': '+86-18800161355'}], 'facility': 'China National Center for Cardiovascular Diseases', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}], 'centralContacts': [{'name': 'Yan Yao, MD,PhD', 'role': 'CONTACT', 'email': 'ianyao@263.net.cn', 'phone': '+86-13901121319'}, {'name': 'Shangyu Liu, MD', 'role': 'CONTACT', 'email': 'liushangyu_yu_fw@163.com', 'phone': '+86-18800161355'}], 'overallOfficials': [{'name': 'Yan Yao, MD,PhD', 'role': 'STUDY_CHAIR', 'affiliation': 'China National Center for Cardiovascular Diseases'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'China National Center for Cardiovascular Diseases', 'class': 'OTHER_GOV'}, 'collaborators': [{'name': 'Renmin Hospital of Wuhan University', 'class': 'OTHER'}, {'name': 'The First Affiliated Hospital with Nanjing Medical University', 'class': 'OTHER'}, {'name': 'Second Affiliated Hospital of Nanchang University', 'class': 'OTHER'}, {'name': 'Sir Run Run Shaw Hospital', 'class': 'OTHER'}, {'name': 'West China Hospital', 'class': 'OTHER'}, {'name': 'Beijing Anzhen Hospital', 'class': 'OTHER'}, {'name': 'General Hospital of Shenyang Military Region', 'class': 'OTHER'}, {'name': 'Xuzhou Central Hospital', 'class': 'OTHER'}, {'name': 'First Affiliated Hospital, Sun Yat-Sen University', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}