Ignite Creation Date:
2025-12-25 @ 4:28 AM
Ignite Modification Date:
2025-12-26 @ 3:31 AM
Study NCT ID:
NCT03797820
Status:
UNKNOWN
Last Update Posted:
2021-07-15
First Post:
2018-12-24
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Multicenter Registry Study of Aortic Valve Stenosis in Zhejiang Elderly（Mrs AVS）
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006349', 'term': 'Heart Valve Diseases'}], 'ancestors': [{'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 1}, 'targetDuration': '1 Year', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2018-10-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-07', 'completionDateStruct': {'date': '2024-09-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2021-07-14', 'studyFirstSubmitDate': '2018-12-24', 'studyFirstSubmitQcDate': '2019-01-05', 'lastUpdatePostDateStruct': {'date': '2021-07-15', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-01-09', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-09-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'All-cause mortality,disabling strokes and Surgical or transcatheter aortic valve replacement', 'timeFrame': 'one year', 'description': 'time from enrolled to first occurrence of any of the components of the composite outcome'}], 'secondaryOutcomes': [{'measure': 'Hospitalization for heart failure', 'timeFrame': 'one year', 'description': 'time from enrolled to first occurrence of the outcome'}, {'measure': 'Surgical or transcatheter aortic valve replacement', 'timeFrame': 'one year', 'description': 'time from enrolled to first occurrence of the outcome'}, {'measure': 'Cardiovascular death', 'timeFrame': 'one year', 'description': 'time from enrolled to first occurrence of the outcome'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Valvular Heart Disease']}, 'referencesModule': {'references': [{'pmid': '27908608', 'type': 'BACKGROUND', 'citation': 'Hu P, Liu XB, Liang J, Zhu QF, Pu CX, Tang MY, Wang JA. A hospital-based survey of patients with severe valvular heart disease in China. Int J Cardiol. 2017 Mar 15;231:244-247. doi: 10.1016/j.ijcard.2016.11.301. Epub 2016 Nov 25.'}], 'seeAlsoLinks': [{'url': 'http://www.ncbi.nlm.nih.gov/pubmed/27908608', 'label': 'A hospital-based survey of patients with severe valvular heart disease in China'}]}, 'descriptionModule': {'briefSummary': 'Aortic valve stenosis (AVS) is becoming more and more frequent with the aging, which has brought a heavy burden to the world. However, the prevalence and prognosis of valvular heart disease are not so clear, especially in the developing countries such as China etc. Because of the slow and progressive nature of AVS, symptoms might not be too severe to be diagnosed on time. Our retrospective survey (Int J Cardiol. 2016 Nov 25) indicated that severe aortic valve stenosis are very common in China. Hence, we design a prospective, observational cohort study to provide contemporary information on the prevalence, characteristics, risk stratification，cost-effective ,treatments and prognosis of Chinese elderly patients with aortic valve stenosis.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '90 Years', 'minimumAge': '60 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients over 60 years old and moderate or above aortic stenosis', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1\\. Patients over 60 years old meet the following condition moderate or above aortic stenosis as defined by echocardiography: Aortic stenosis, moderate or above, or valve area≤1.5cm2, or maximal jet velocity ≥3.0m/sec, or mean pressure gradient≥20mmHg\n\nExclusion Criteria:\n\n1. Patients cannot be followed up for any reasons.\n2. Patients in critical condition may be die in one year.\n3. Patients have been enrolled in this study.'}, 'identificationModule': {'nctId': 'NCT03797820', 'briefTitle': 'Multicenter Registry Study of Aortic Valve Stenosis in Zhejiang Elderly（Mrs AVS）', 'organization': {'class': 'OTHER', 'fullName': 'Second Affiliated Hospital, School of Medicine, Zhejiang University'}, 'officialTitle': 'A Prospective, Multicenter,Registry Study of Aortic Valve Stenosis in Zhejiang Elderly', 'orgStudyIdInfo': {'id': 'SAHZJU CT012'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Our study type is observational', 'type': 'OTHER', 'description': 'Our study type is observational'}]}, 'contactsLocationsModule': {'locations': [{'zip': '310000', 'city': 'Hangzhou', 'state': 'Zhejiang', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Xianbao Liu, MD', 'role': 'CONTACT', 'email': 'liuxb2009@hotmail.com', 'phone': '+86-13857173887'}], 'facility': 'Second Affiliated Hospital Zhejiang University School of Medicine', 'geoPoint': {'lat': 30.29365, 'lon': 120.16142}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Second Affiliated Hospital, School of Medicine, Zhejiang University', 'class': 'OTHER'}, 'collaborators': [{'name': 'First Affiliated Hospital of Wenzhou Medical University', 'class': 'OTHER'}, {'name': 'Second Affiliated Hospital of Wenzhou Medical University', 'class': 'OTHER'}, {'name': 'Jinhua Central Hospital', 'class': 'OTHER'}, {'name': 'The Second Affiliated Hospital of Jiaxing University', 'class': 'OTHER'}, {'name': 'The Fourth Affiliated Hospital of Zhejiang University School of Medicine', 'class': 'OTHER'}, {'name': 'The Central Hospital of Lishui City', 'class': 'OTHER'}, {'name': 'Sir Run Run Shaw Hospital', 'class': 'OTHER'}, {'name': 'Ningbo Medical Center Lihuili Hospital', 'class': 'OTHER_GOV'}, {'name': 'Ningbo No. 1 Hospital', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'President of Second Affiliated Hospital, School of Medicine, Zhejiang University & Chief of Cardiology', 'investigatorFullName': "Jian'an Wang,MD,PhD", 'investigatorAffiliation': 'Second Affiliated Hospital, School of Medicine, Zhejiang University'}}}}