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Cardiovascular Risk Assessment and Dynamic Monitoring-based Prevention Trial

NCT05919056 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 22032

Last updated 2024-11-15

No results posted yet for this 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.

Conditions

Interventions

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.

OTHER

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).

OTHER

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").

Sponsors & Collaborators

  • Yinzhou District Center for Disease Control and Prevention

    collaborator UNKNOWN

  • Peking University

    lead OTHER

Principal Investigators

  • Xun TANG, PhD, MHS

  • Pei GAO, PhD

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
40 Years
Max Age
79 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-07-06
Primary Completion
2028-07-01
Completion
2028-07-01

Countries

  • China

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05919056 on ClinicalTrials.gov