Ignite Creation Date:
2025-12-24 @ 9:28 PM
Ignite Modification Date:
2025-12-25 @ 7:13 PM
Study NCT ID:
NCT06069232
Status:
RECRUITING
Last Update Posted:
2023-10-12
First Post:
2023-10-01
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Aortic Valve Diseases RISk facTOr assessmenT and Prognosis modeL Construction
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000082862', 'term': 'Aortic Valve Disease'}, {'id': 'D001024', 'term': 'Aortic Valve Stenosis'}, {'id': 'D001022', 'term': 'Aortic Valve Insufficiency'}], 'ancestors': [{'id': 'D006349', 'term': 'Heart Valve Diseases'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D014694', 'term': 'Ventricular Outflow Obstruction'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 2000}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2021-03-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-10', 'completionDateStruct': {'date': '2028-03-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-10-10', 'studyFirstSubmitDate': '2023-10-01', 'studyFirstSubmitQcDate': '2023-10-01', 'lastUpdatePostDateStruct': {'date': '2023-10-12', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-10-05', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2028-03-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'all-cause mortality', 'timeFrame': 'from baseline to death or end of follow-up', 'description': 'death caused by any cause'}], 'secondaryOutcomes': [{'measure': 'Cardiovascular death', 'timeFrame': 'from baseline to death or end of follow-up', 'description': 'Death caused by cardiac causes'}, {'measure': 'Aortic valve replacement', 'timeFrame': 'from baseline to aortic valve replacement', 'description': 'Transcatheter aortic valve replacement or surgical aortic valve replacement'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['aortic stenosis', 'aortic valve insufficiency', 'risk factor', 'prediction model'], 'conditions': ['Aortic Valve Disease']}, 'referencesModule': {'references': [{'pmid': '41076530', 'type': 'DERIVED', 'citation': 'Guo Z, Xiong Z, Zhang W, Chen G, Xie M, Zhou Z, Zhang S, Liu M, Li J, Liao X, Zhuang X. Association between cholesterol, high-density lipoprotein, and glucose index and risks of cardiovascular and all-cause mortality in patients with calcific aortic valve stenosis: the ARISTOTLE cohort study. Cardiovasc Diabetol. 2025 Oct 11;24(1):393. doi: 10.1186/s12933-025-02906-2.'}, {'pmid': '39895526', 'type': 'DERIVED', 'citation': 'Li B, Zhang S, Xu C, Huang M, Xiong Z, Hui Z, Liao X, Li J, Chen J, Zhuang X. Association Between the Malnutrition Status and All-Cause Mortality in Patients With Moderate and Severe Aortic Stenosis: A Prospective Cohort Study. J Am Heart Assoc. 2025 Feb 4;14(3):e037086. doi: 10.1161/JAHA.124.037086. Epub 2025 Feb 3.'}]}, 'descriptionModule': {'briefSummary': 'This study is a multicenter cohort study including patients diagnosed with aortic valve disease during hospitalization, including aortic insufficiency and aortic valve stenosis. The primary outcome of the study was all-cause death, and the secondary outcome was cardiovascular events. Through follow-up observation, the prognostic risk factors of patients with aortic disease were evaluated, and a prognostic model was constructed to guide clinical decision-making.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '100 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'The participant included in this study were patients with aortic valve disease diagnosed during hospitalization, and these patients were followed up for a long time after discharge.', 'eligibilityCriteria': 'Inclusion Criteria:\n\n* age ≥ 18\n* diagnosed as aortic valve disease\n\nExclusion Criteria:\n\n* aortic valve replacement at baseline'}, 'identificationModule': {'nctId': 'NCT06069232', 'acronym': 'ARISTOTLE', 'briefTitle': 'Aortic Valve Diseases RISk facTOr assessmenT and Prognosis modeL Construction', 'organization': {'class': 'OTHER', 'fullName': 'Sun Yat-sen University'}, 'officialTitle': 'Aortic Valve Diseases RISk facTOr assessmenT and Prognosis modeL Construction (ARISTOTLE)', 'orgStudyIdInfo': {'id': 'ARISTOTLE Study'}}, 'contactsLocationsModule': {'locations': [{'zip': '510000', 'city': 'Guangzhou', 'state': 'Guangdong', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'xiaodong zhuang, PhD', 'role': 'CONTACT', 'email': 'zhuangxd3@mail.sysu.edu.cn', 'phone': '+86 13760755035'}], 'facility': 'First Affiliated Hospital, Sun Yat-Sen University', 'geoPoint': {'lat': 23.11667, 'lon': 113.25}}, {'zip': '510000', 'city': 'Guangzhou', 'state': 'Guangdong', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'zhuoshan Huang, PhD', 'role': 'CONTACT', 'email': 'huangzhsh@mail.sysu.edu.cn', 'phone': '+86 13728059476'}], 'facility': 'Third Affiliated Hospital, Sun Yat-Sun University', 'geoPoint': {'lat': 23.11667, 'lon': 113.25}}, {'zip': '522000', 'city': 'Jieyang', 'state': 'Guangdong', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Mingwei Xu, PhD', 'role': 'CONTACT', 'email': 'versy@163.com', 'phone': '13828186368'}], 'facility': "Jieyang People's Hospital", 'geoPoint': {'lat': 23.5418, 'lon': 116.36581}}, {'zip': '515041', 'city': 'Shantou', 'state': 'Guangdong', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Jilin Li, PhD', 'role': 'CONTACT', 'email': 'lijilin@126.com', 'phone': '+86 13592852807'}], 'facility': 'Second Affiliated Hospital of Shantou University Medical College', 'geoPoint': {'lat': 23.35489, 'lon': 116.67876}}, {'zip': '518000', 'city': 'Shenzhen', 'state': 'Guangdong', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'jianwen liang, PhD', 'role': 'CONTACT', 'email': 'liangjw39@mail.sysu.edu.cn', 'phone': '+86 13688847419'}], 'facility': 'Eighth Affiliated Hospital, Sun Yat-Sen University', 'geoPoint': {'lat': 22.54554, 'lon': 114.0683}}, {'zip': '524001', 'city': 'Zhanjiang', 'state': 'Guangdong', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Jianying Chen, PhD', 'role': 'CONTACT', 'email': 'jychen271@126.com', 'phone': '+86 13828223032'}], 'facility': 'Affiliated Hospital of Guangdong Medical University', 'geoPoint': {'lat': 21.23391, 'lon': 110.38749}}, {'zip': '528400', 'city': 'Zhongshan', 'state': 'Guangdong', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'li Feng, PhD', 'role': 'CONTACT', 'email': 'lifengdoc@126.com', 'phone': '+86 13902593410'}], 'facility': "Zhongshan People's Hospital", 'geoPoint': {'lat': 22.52306, 'lon': 113.37912}}], 'centralContacts': [{'name': 'xiaodong zhuang, PhD', 'role': 'CONTACT', 'email': 'zhuangxd3@mail.sysu.edu.cn', 'phone': '+86 13760755035'}], 'overallOfficials': [{'name': 'xiaodong zhuang, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'First Affiliated Hospital, Sun Yat-Sen University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Sun Yat-sen University', 'class': 'OTHER'}, 'collaborators': [{'name': 'First Affiliated Hospital, Sun Yat-Sen University', 'class': 'OTHER'}, {'name': 'Third Affiliated Hospital, Sun Yat-Sen University', 'class': 'OTHER'}, {'name': 'Affiliated Hospital of Guangdong Medical University', 'class': 'OTHER'}, {'name': 'Second Affiliated Hospital of Shantou University Medical College', 'class': 'OTHER'}, {'name': 'Eighth Affiliated Hospital, Sun Yat-sen University', 'class': 'OTHER'}, {'name': "Zhongshan People's Hospital, Guangdong, China", 'class': 'OTHER'}, {'name': "Jieyang People's Hospital", 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Xiao-dong Zhuang', 'investigatorAffiliation': 'Sun Yat-sen University'}}}}