Cardiovascular Risk Assessment and Dynamic Monitoring-based Prevention Trial

ConditionCardiovascular Diseases

Trial statusRecruiting

Trial phaseNot applicable

Trial typeInterventional

Biological sexAll

Age40-79

SponsorPeking University

About this trial

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 criteria

This trial does not accept healthy volunteers

Qualifiers

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%);

Disqualifiers

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

Patients with a diagnosis of cancer;

Refused to provide written informed consent

Trial design

Design model

Parallel

Treatments tested in this trial

Frequent and automatic cardiovascular risk assessment
Other intervention
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
Other intervention
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
Other intervention
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").

Treatment groups

22,032 Participants

are divided into 2 treatment groups

Group A: Intervention armExperimental treatment 3 interventions

Group B: Control armNo intervention 0 interventions

Trial outcomes

Primary outcomes

Primary Outcome of Phase I: Change in cardiovascular risk score

The change in cardiovascular risk scores calculated by 2019 WHO laboratory-based risk charts

Time frame

24 months after baseline

Primary Outcome of Phase II: Major adverse cardiovascular events (MACE)

Incidence of coronary heart disease, stroke, heart failure and all-cause mortality

Time frame

60 months after baseline

Secondary outcomes

Secondary Outcome of Phase I: Change in systolic blood pressure

the change in systolic blood pressure from baseline

Time frame

24 months after baseline

Secondary Outcome of Phase I: Change in total cholesterol

the change in total cholesterol from baseline

Time frame

24 months after baseline

Secondary Outcome of Phase I: Change in low-density lipoprotein cholesterol

the change in low-density lipoprotein cholesterol from baseline

Time frame

24 months after baseline

Secondary Outcome of Phase II: Change in health-related quality of life

Measured using the EuroQol-5 Dimensions-5L(EQ-5D)

Time frame

60 months after baseline

Other outcomes

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

Time frame

60 months after baseline

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Peking University

Lead sponsor

Center for Disease Control and Prevention of Yinzhou District, Ningbo City, China

Collaborator

Source ClinicalTrials.gov

Apply now