Cardiovascular Risk Assessment and Dynamic Monitoring-based Prevention Trial

Condition(s) studied

Investigational drug(s) / intervention(s)

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").

Study 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.

Eligibility

Primary outcome measure(s)

• Primary Outcome of Phase I: Change in cardiovascular risk score — 24 months after baseline
  The change in cardiovascular risk scores calculated by 2019 WHO laboratory-based risk charts
• Primary Outcome of Phase II: Major adverse cardiovascular events (MACE) — 60 months after baseline
  Incidence of coronary heart disease, stroke, heart failure and all-cause mortality

Trial sites (1)

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