Ignite Creation Date:
2025-12-24 @ 11:30 PM
Ignite Modification Date:
2026-01-07 @ 2:00 AM
Study NCT ID:
NCT05919056
Status:
RECRUITING
Last Update Posted:
2024-11-15
First Post:
2023-06-16
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Cardiovascular Risk Assessment and Dynamic Monitoring-based Prevention Trial
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 22032}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-07-06', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-11', 'completionDateStruct': {'date': '2028-07-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-11-14', 'studyFirstSubmitDate': '2023-06-16', 'studyFirstSubmitQcDate': '2023-06-16', 'lastUpdatePostDateStruct': {'date': '2024-11-15', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-06-26', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2028-07-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Other Pre-specified Outcome of Phase II: Incremental cost-effectiveness ratio (ICER)', 'timeFrame': '60 months after baseline', 'description': 'the incremental cost-effectiveness ratio (ICER) of the management provided by the interventions compared to the usual care'}], 'primaryOutcomes': [{'measure': 'Primary Outcome of Phase I: Change in cardiovascular risk score', 'timeFrame': '24 months after baseline', 'description': 'The change in cardiovascular risk scores calculated by 2019 WHO laboratory-based risk charts'}, {'measure': 'Primary Outcome of Phase II: Major adverse cardiovascular events (MACE)', 'timeFrame': '60 months after baseline', 'description': 'Incidence of coronary heart disease, stroke, heart failure and all-cause mortality'}], 'secondaryOutcomes': [{'measure': 'Secondary Outcome of Phase I: Change in systolic blood pressure', 'timeFrame': '24 months after baseline', 'description': 'the change in systolic blood pressure from baseline'}, {'measure': 'Secondary Outcome of Phase I: Change in total cholesterol', 'timeFrame': '24 months after baseline', 'description': 'the change in total cholesterol from baseline'}, {'measure': 'Secondary Outcome of Phase I: Change in low-density lipoprotein cholesterol', 'timeFrame': '24 months after baseline', 'description': 'the change in low-density lipoprotein cholesterol from baseline'}, {'measure': 'Secondary Outcome of Phase II: Change in health-related quality of life', 'timeFrame': '60 months after baseline', 'description': 'Measured using the EuroQol-5 Dimensions-5L(EQ-5D)'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['primary prevention', 'cluster randomized trial', 'cardiovascular risk assessment'], 'conditions': ['Cardiovascular Diseases']}, 'referencesModule': {'references': [{'pmid': '29440217', 'type': 'BACKGROUND', 'citation': 'Lin H, Tang X, Shen P, Zhang D, Wu J, Zhang J, Lu P, Si Y, Gao P. Using big data to improve cardiovascular care and outcomes in China: a protocol for the CHinese Electronic health Records Research in Yinzhou (CHERRY) Study. BMJ Open. 2018 Feb 12;8(2):e019698. doi: 10.1136/bmjopen-2017-019698.'}, {'type': 'BACKGROUND', 'citation': 'Liu XF, Li QQ, Chen WY, et al. A dynamic risk-based early warning monitoring system for population-based management of cardiovascular disease. Fundamental Research. 2021:534-542.'}, {'pmid': '36340248', 'type': 'BACKGROUND', 'citation': 'Liu X, Shen P, Zhang D, Sun Y, Chen Y, Liang J, Wu J, Zhang J, Lu P, Lin H, Tang X, Gao P. Evaluation of Atherosclerotic Cardiovascular Risk Prediction Models in China: Results From the CHERRY Study. JACC Asia. 2022 Jan 4;2(1):33-43. doi: 10.1016/j.jacasi.2021.10.007. eCollection 2022 Feb.'}]}, 'descriptionModule': {'briefSummary': 'The CRITICALLY study is a cluster randomized trial that will evaluate the effectiveness of a risk-based dynamic monitoring strategy for the primary prevention of cardiovascular high-risk Chinese adults.', 'detailedDescription': 'The objective of the study is to evaluate the effectiveness of a risk-based management strategy on cardiovascular risk scores (calculated by the 2019 WHO cardiovascular risk charts) in 24 months (Phase I) and the incidence of major adverse cardiovascular events in 60 months (Phase II). Totally 216 clinics in Yinzhou District, China will be randomized to the intervention or the control arms with usual care. The interventions supported by the web-based decision support system include (1) cardiovascular risk assessment, (2) dynamic risk monitoring, and (3) regular visits by the general practitioner every three months. Only usual care will be provided in the control arm. The primary outcome is the change in cardiovascular risk scores for Phase I and the incidence of the composite endpoint of coronary heart disease, stroke, heart failure and all-cause mortality for Phase II. If the comprehensive strategy is proven effective, it could provide evidence for the primary prevention of cardiovascular diseases using digital health technology.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '79 Years', 'minimumAge': '40 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Residents in the Yinzhou District have a unique health ID;\n* Aged 40 to 79 years at the baseline enrollment;\n* With high risk of cardiovascular disease evaluated by the 2019 WHO laboratory-based risk models (10-year riskā„10%);\n\nExclusion Criteria:\n\n* Have a history of coronary heart disease, stroke or heart failure;\n* Patients with a diagnosis of cancer;\n* Refused to provide written informed consent'}, 'identificationModule': {'nctId': 'NCT05919056', 'acronym': 'CRITICALLY', 'briefTitle': 'Cardiovascular Risk Assessment and Dynamic Monitoring-based Prevention Trial', 'organization': {'class': 'OTHER', 'fullName': 'Peking University'}, 'officialTitle': 'Cardiovascular Risk Assessment and dynamIc Monitoring-based Prevention Trial for prImary Care quALity evaLuation in Yinzhou', 'orgStudyIdInfo': {'id': 'IRB00001052-21060'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Intervention arm', 'description': 'The interventions include cardiovascular risk assessment, dynamic risk monitoring, and regular general practitioner (GP) visits. The frequency of risk assessment, risk monitoring, and automatic mobile texting will be once per month, while regular GP visits will be once per three months.', 'interventionNames': ['Other: Frequent and automatic cardiovascular risk assessment', 'Other: Dynamic risk monitoring', 'Other: Regular GP visits']}, {'type': 'NO_INTERVENTION', 'label': 'Control arm', 'description': 'Current regular management (usual care) will be kept in the control arm. The management objectives are for patients with hypertension or diabetes mellitus. The frequency of follow-up is at least once per three months.'}], 'interventions': [{'name': 'Frequent and automatic cardiovascular risk assessment', 'type': 'OTHER', 'description': 'The 10-year cardiovascular risk scores using the 2019 World Health Organization (WHO) laboratory-based risk charts will be automatically calculated using the latest health information on an EHR-based system per month.', 'armGroupLabels': ['Intervention arm']}, {'name': 'Dynamic risk monitoring', 'type': 'OTHER', 'description': 'High-risk individuals will be reassessed by the Dynamic Risk-based Early wArning and Monitoring (DREAM) system to obtain the short-term risk. The DREAM system will send a text message about advice to the high-risk individual every month. The text message includes information on the health status (e.g., current cardiovascular risk, level of blood pressure and lipid) and real-time warning messages (e.g., high short-term risk).', 'armGroupLabels': ['Intervention arm']}, {'name': 'Regular GP visits', 'type': 'OTHER', 'description': 'The general practitioners will communicate with the participants based on the information automatically generated from the DREAM system every three months: each participant\'s cardiovascular risk score, health status (e.g., diabetes mellitus and/or hypertension), and Chinese guidelines-based recommendations (e.g., "for the management of dyslipidemia, to provide clear treatment targets for high-risk participants").', 'armGroupLabels': ['Intervention arm']}]}, 'contactsLocationsModule': {'locations': [{'zip': '315100', 'city': 'Ningbo', 'state': 'Zhejiang', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Peng SHEN, MPH', 'role': 'CONTACT', 'email': 'shen-peng@foxmail.com', 'phone': '+86-574-87418718'}], 'facility': 'Yinzhou District Center for Disease Control and Prevention', 'geoPoint': {'lat': 29.87819, 'lon': 121.54945}}], 'centralContacts': [{'name': 'Xun TANG, PhD, MHS', 'role': 'CONTACT', 'email': 'tangxun@bjmu.edu.cn', 'phone': '+86-10-82801528 ext 317'}], 'overallOfficials': [{'name': 'Xun TANG, PhD, MHS', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Pei GAO, PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': "According to the Administrative Regulations on Human Genetic Resources issued by the State Council of the People's Republic of China in 2019, we are waiting for the approval of IPD sharing."}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Peking University', 'class': 'OTHER'}, 'collaborators': [{'name': 'Yinzhou District Center for Disease Control and Prevention', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Pei Gao', 'investigatorAffiliation': 'Peking University'}}}}