Cardiovascular Risk Assessment and Dynamic Monitoring-based Prevention Trial
NCT ID: NCT05919056
Last Updated: 2024-11-15
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
RECRUITING
NA
22032 participants
INTERVENTIONAL
2023-07-06
2028-07-01
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Mobile Application for Cardiovascular Risk Treatment
NCT05712070
China Rural Hypertension Control Project
NCT03527719
A Study to Define the Distribution of Type of Hypertension in Asia by Blood Pressure Monitoring at Home (Asia BP@Home)
NCT03096119
Non-Invasive Aortic Ambulatory Blood Pressure Monitoring for The Detection of Target Organ Damage in The Chinese Population
NCT03154203
Effect of Healthy Family Program on Population Blood Pressure
NCT06427096
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
PREVENTION
SINGLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Intervention arm
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.
Frequent and automatic cardiovascular risk assessment
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.
Dynamic risk monitoring
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).
Regular GP visits
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").
Control arm
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.
No interventions assigned to this group
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Frequent and automatic cardiovascular risk assessment
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.
Dynamic risk monitoring
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).
Regular GP visits
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").
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Aged 40 to 79 years at the baseline enrollment;
* With high risk of cardiovascular disease evaluated by the 2019 WHO laboratory-based risk models (10-year riskā„10%);
Exclusion Criteria
* Patients with a diagnosis of cancer;
* Refused to provide written informed consent
40 Years
79 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Yinzhou District Center for Disease Control and Prevention
UNKNOWN
Peking University
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Pei Gao
Professor
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Xun TANG, PhD, MHS
Role: PRINCIPAL_INVESTIGATOR
Pei GAO, PhD
Role: PRINCIPAL_INVESTIGATOR
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Yinzhou District Center for Disease Control and Prevention
Ningbo, Zhejiang, China
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
References
Explore related publications, articles, or registry entries linked to this study.
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.
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.
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.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
IRB00001052-21060
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.