Cardiovascular Risk Assessment and Dynamic Monitoring-based Prevention Trial

Cardiovascular Diseases Clinical Trial

— CRITICALLY  

Official title:

Cardiovascular Risk Assessment and dynamIc Monitoring-based Prevention Trial for prImary Care quALity evaLuation in Yinzhou

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05919056
• Other study ID #: IRB00001052-21060
• Status: Recruiting
• Phase: N/A
• Start date: July 6, 2023
• Est. completion date: July 1, 2028

Study information

• Verified date: July 2023
• Source: Peking University
• Contact: Xun TANG, PhD, MHS
• Phone: +86-10-82801528 ext 317
• Email: tangxun[@]bjmu.edu.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 22032
• Est. completion date: July 1, 2028
• Est. primary completion date: July 1, 2028
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years to 79 Years

Eligibility

Inclusion Criteria:

• Residents in the Yinzhou District have a unique health ID;

• 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 risk=10%);

Exclusion Criteria:

• Have a history of coronary heart disease, stroke or heart failure;

• Patients with a diagnosis of cancer;

• Refused to provide written informed consent

Related Conditions & MeSH terms

• Cardiovascular Diseases

Intervention

Other:
• 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").

Locations

Country	Name	City	State
China	Yinzhou District Center for Disease Control and Prevention	Ningbo	Zhejiang

Sponsors (2)

Lead Sponsor	Collaborator
Peking University	Yinzhou District Center for Disease Control and Prevention

Country where clinical trial is conducted

China, 

References & Publications (3)

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. — View 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. — View 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.

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Other Pre-specified Outcome of Phase II: Incremental cost-effectiveness ratio (ICER)	the incremental cost-effectiveness ratio (ICER) of the management provided by the interventions compared to the usual care	60 months after baseline
Primary	Primary Outcome of Phase I: Change in cardiovascular risk score	The change in cardiovascular risk scores calculated by 2019 WHO laboratory-based risk charts	24 months after baseline
Primary	Primary Outcome of Phase II: Major adverse cardiovascular events (MACE)	Incidence of coronary heart disease, stroke, heart failure and all-cause mortality	60 months after baseline
Secondary	Secondary Outcome of Phase I: Change in systolic blood pressure	the change in systolic blood pressure from baseline	24 months after baseline
Secondary	Secondary Outcome of Phase I: Change in total cholesterol	the change in total cholesterol from baseline	24 months after baseline
Secondary	Secondary Outcome of Phase I: Change in low-density lipoprotein cholesterol	the change in low-density lipoprotein cholesterol from baseline	24 months after baseline
Secondary	Secondary Outcome of Phase II: Change in health-related quality of life	Measured using the EuroQol-5 Dimensions-5L(EQ-5D)	60 months after baseline