Cardiovascular Risk Assessment and Dynamic Monitoring-based Prevention Trial

Not Applicable

Recruiting

• Conditions: Cardiovascular Diseases
• Interventions: Other: Frequent and automatic cardiovascular risk assessment; Other: Dynamic risk monitoring; Other: Regular GP visits

• Registration Number: NCT05919056
• Lead Sponsor: Peking University

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.

Study Timeline

• Study First Submitted: 2023-06-16
• Study First Submitted QC: 2023-06-16
• Study First Posted: 2023-06-26
• Study Start: 2023-07-06
• Status Verified: 2024-11
• Last Update Submitted: 2024-11-14
• Last Update Posted: 2024-11-15
• Primary Completion: 2028-07-01
• Study Completion: 2028-07-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 22032

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intervention arm	Frequent and automatic cardiovascular risk assessment	The interventions include cardiovascular risk assessment, dynamic risk monitoring, and regular general practitioner (GP) visits. The frequency of risk assessment, risk monitoring, and automatic mobile texting will be once per month, while regular GP visits will be once per three months.
Intervention arm	Dynamic risk monitoring	The interventions include cardiovascular risk assessment, dynamic risk monitoring, and regular general practitioner (GP) visits. The frequency of risk assessment, risk monitoring, and automatic mobile texting will be once per month, while regular GP visits will be once per three months.
Intervention arm	Regular GP visits	The interventions include cardiovascular risk assessment, dynamic risk monitoring, and regular general practitioner (GP) visits. The frequency of risk assessment, risk monitoring, and automatic mobile texting will be once per month, while regular GP visits will be once per three months.

Primary Outcome Measures

Name	Time	Method
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

Secondary Outcome Measures

Name	Time	Method
Secondary Outcome of Phase II: Change in health-related quality of life	60 months after baseline	Measured using the EuroQol-5 Dimensions-5L(EQ-5D)
Secondary Outcome of Phase I: Change in systolic blood pressure	24 months after baseline	the change in systolic blood pressure from baseline
Secondary Outcome of Phase I: Change in total cholesterol	24 months after baseline	the change in total cholesterol from baseline
Secondary Outcome of Phase I: Change in low-density lipoprotein cholesterol	24 months after baseline	the change in low-density lipoprotein cholesterol from baseline

Trial Locations

Locations (1)

Yinzhou District Center for Disease Control and Prevention; 🇨🇳 Ningbo, Zhejiang, China