Clinical trial NCT05919056: Cardiovascular Risk Assessment and Dynamic Monitoring-based Prevention Trial
Official title: Cardiovascular Risk Assessment and dynamIc Monitoring-based Prevention Trial for prImary Care quALity evaLuation in Yinzhou
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Cardiovascular Diseases
Keywords: primary prevention
cluster randomized trial
cardiovascular risk assessment
Lead sponsor: Peking University
Sponsor class: OTHER
Collaborators: name: Yinzhou District Center for Disease Control and Prevention
First posted: 2023-06-26
Enrollment: 22032
Sex: ALL
Minimum age (years): 40
Maximum age (years): 79
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Primary Outcome of Phase I: Change in cardiovascular risk score
timeFrame: 24 months after baseline
measure: Primary Outcome of Phase II: Major adverse cardiovascular events (MACE)
timeFrame: 60 months after baseline
Secondary outcomes:
measure: Secondary Outcome of Phase I: Change in systolic blood pressure
timeFrame: 24 months after baseline
measure: Secondary Outcome of Phase I: Change in total cholesterol
timeFrame: 24 months after baseline
measure: Secondary Outcome of Phase I: Change in low-density lipoprotein cholesterol
timeFrame: 24 months after baseline
measure: Secondary Outcome of Phase II: Change in health-related quality of life
timeFrame: 60 months after baseline
Other outcomes:
measure: Other Pre-specified Outcome of Phase II: Incremental cost-effectiveness ratio (ICER)
timeFrame: 60 months after baseline
Locations:
city: Ningbo
country: China
facility: Yinzhou District Center for Disease Control and Prevention
state: Zhejiang
Study officials:
name: Xun TANG, PhD, MHS
role: PRINCIPAL_INVESTIGATOR
name: Pei GAO, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
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.