Ignite Creation Date:
2025-12-25 @ 4:05 AM
Ignite Modification Date:
2025-12-26 @ 3:01 AM
Study NCT ID:
NCT05797402
Status:
UNKNOWN
Last Update Posted:
2023-04-04
First Post:
2023-02-22
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Clinical and Biological Sample Database of Chinese Elderly Patients With Multiple Diseases
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000073496', 'term': 'Frailty'}, {'id': 'D003072', 'term': 'Cognition Disorders'}, {'id': 'D003327', 'term': 'Coronary Disease'}, {'id': 'D001281', 'term': 'Atrial Fibrillation'}, {'id': 'D020521', 'term': 'Stroke'}, {'id': 'D006333', 'term': 'Heart Failure'}, {'id': 'D006973', 'term': 'Hypertension'}, {'id': 'D006349', 'term': 'Heart Valve Diseases'}], 'ancestors': [{'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D019965', 'term': 'Neurocognitive Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}, {'id': 'D017202', 'term': 'Myocardial Ischemia'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D001145', 'term': 'Arrhythmias, Cardiac'}, {'id': 'D002561', 'term': 'Cerebrovascular Disorders'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 10000000}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2013-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-04', 'completionDateStruct': {'date': '2023-06', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-04-02', 'studyFirstSubmitDate': '2023-02-22', 'studyFirstSubmitQcDate': '2023-04-02', 'lastUpdatePostDateStruct': {'date': '2023-04-04', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-04-04', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-05-15', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The incidence of geriatric syndromes including falls, cognitive impairment, dizziness and frailty', 'timeFrame': '1 year', 'description': 'collection of clinical data in the medical record and follow-up update'}], 'secondaryOutcomes': [{'measure': 'The incidence of survival rate', 'timeFrame': '1 year', 'description': 'collection of clinical data in the medical record and follow-up update'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Cognition Disorders', 'Frailty', 'Coronary heart disease', 'Atrial fibrillation', 'Stroke', 'Heart failure', 'Hypertension', 'Valvular heart disease'], 'conditions': ['Comorbidities and Coexisting Conditions', 'Old Age; Debility']}, 'referencesModule': {'references': [{'pmid': '40527568', 'type': 'DERIVED', 'citation': 'Huang X, Zheng W, Wang X, Suo M, Zhao X, Nie S. Association between Charlson Comorbidity Index and in-hospital outcomes among aortic stenosis patients undergoing aortic valve replacement: an observational study at the National Clinical Research Center for Cardiovascular Diseases. BMJ Open. 2025 Jun 17;15(6):e083677. doi: 10.1136/bmjopen-2023-083677.'}, {'pmid': '38544919', 'type': 'DERIVED', 'citation': 'Zheng W, Huang X, Wang X, Suo M, Yan Y, Gong W, Ai H, Que B, Nie S. Impact of multimorbidity patterns on outcomes and treatment in patients with coronary artery disease. Eur Heart J Open. 2024 Mar 27;4(2):oeae009. doi: 10.1093/ehjopen/oeae009. eCollection 2024 Mar.'}]}, 'descriptionModule': {'briefSummary': 'The investigators aim to establish a clinical database and biobank for elderly patients with multiple diseases. The collected data will include demographic information, comorbidity characteristic, FRAIL scale, age-adjusted Charlson comorbidity index, relevant blood tests, the results of imaging examination, prescription of drugs, length of hospital stay, number of overall rehospitalizations and death. With this database, the investigators intend to formulate an individualized treatment strategy for these patients.', 'detailedDescription': 'According to the China Health and Aging Tracking Survey, a significant proportion of elderly individuals aged over 65 suffer from two or more chronic diseases, with prevalence rates ranging from 22.5% to 47.5%. However, due to the decentralized storage of health data, lack of standardization, and collaboration barriers, it is challenging to make use of this information in a meaningful way.Therefore, there is an urgent need to overcome the technical challenges and build an intelligent diagnosis and treatment system for this vulnerable population.\n\nTo achieve this goal, it is necessary to establish a clinical database and biobank that includes data on all elderly patients with multimorbidity. This will enable researchers to conduct clinical research on various factors, including clinical and biological predictors of adverse events such as emergency visits, strokes, heart failure, myocardial infarction, tumors, and acute chronic obstructive pulmonary disease. Additionally, the database will facilitate the development of systematic and individualized evaluation tools for elderly patients with multimorbidity, identify prognostic factors that improve short- and long-term outcomes, and enable the participation in multi-center trials at the national or international level. Ultimately, this effort will help establish clinical database and biobank data collection standards for future studies.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'hospital based group', 'eligibilityCriteria': 'Inclusion Criteria:\n\n* (1) written and informed consent, (2) participants aged 18 years or older.\n\nExclusion Criteria:\n\n* (1) Unwilling to participate in the study, (2) Unable or unwilling to cooperate with the baseline or follow-up data collection.'}, 'identificationModule': {'nctId': 'NCT05797402', 'briefTitle': 'Clinical and Biological Sample Database of Chinese Elderly Patients With Multiple Diseases', 'organization': {'class': 'OTHER', 'fullName': 'Beijing Anzhen Hospital'}, 'officialTitle': 'Construction of Integrated Management and Sharing Platform for Clinical and Biological Sample Database of Chinese Elderly Patients With Multiple Diseases', 'orgStudyIdInfo': {'id': '2020YFC2004800'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'young-aged patients', 'description': 'Patients aged 18 to 45 years old.'}, {'label': 'middle-aged patients', 'description': 'Patients aged 46 to 64 years old.'}, {'label': 'elderly patients', 'description': 'Patients aged 65 and older.'}]}, 'contactsLocationsModule': {'locations': [{'zip': '100029', 'city': 'Beijing', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Shao-Ping Nie, MD, PhD', 'role': 'CONTACT', 'email': 'spnie@ccmu.edu.cn', 'phone': '86-10-84005256'}, {'name': 'Shao-Ping Nie, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Beijing Anzhen Hospital, Capital Medical University', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}], 'centralContacts': [{'name': 'Shao-ping Nie, MD,PhD', 'role': 'CONTACT', 'email': 'spnie@ccmu.edu.cn', 'phone': '8613701186772'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Beijing Anzhen Hospital', 'class': 'OTHER'}, 'collaborators': [{'name': 'Chinese PLA General Hospital', 'class': 'OTHER'}, {'name': 'Beijing Chao Yang Hospital', 'class': 'OTHER'}, {'name': 'Beijing Tiantan Hospital', 'class': 'OTHER'}, {'name': 'Beijing Geriatric Hospital', 'class': 'OTHER'}, {'name': 'China-Japan Friendship Hospital', 'class': 'OTHER'}, {'name': 'Xuanwu Hospital, Beijing', 'class': 'OTHER'}, {'name': 'Wuhan TongJi Hospital', 'class': 'OTHER'}, {'name': 'Cancer Institute and Hospital, Chinese Academy of Medical Sciences', 'class': 'OTHER'}, {'name': 'Beijing Friendship Hospital', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor of Medicine,Director,Department of Cardiology', 'investigatorFullName': 'Shao-Ping Nie', 'investigatorAffiliation': 'Beijing Anzhen Hospital'}}}}