Cardiovascular Risk Assessment and Dynamic Monitoring-based Prevention Trial (CRITICALLY)

Cardiovascular Risk Assessment and dynamIc Monitoring-based Prevention Trial for prImary Care quALity evaLuation in Yinzhou

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.

Study Overview

• Status: Recruiting
• Conditions: Cardiovascular Diseases
• Intervention / Treatment: Other: Frequent and automatic cardiovascular risk assessment; Other: Dynamic risk monitoring; Other: Regular GP visits

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 Type: Interventional
• Enrollment (Estimated): 22032
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Xun TANG, PhD, MHS; Phone Number: +86-10-82801528 ext 317; Email: tangxun@bjmu.edu.cn

Study Locations

• China
  • Zhejiang
    • Ningbo, Zhejiang, China, 315100
      • Recruiting
      • Yinzhou District Center for Disease Control and Prevention
      • Contact: Peng SHEN, MPH; Phone Number: +86-574-87418718; Email: shen-peng@foxmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intervention arm; 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.	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").
No Intervention: Control arm; Current regular management (usual care) will be kept in the control arm. The management objectives are for patients with hypertension or diabetes mellitus. The frequency of follow-up is at least once per three months.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Primary Outcome of Phase I: Change in cardiovascular risk score	The change in cardiovascular risk scores calculated by 2019 WHO laboratory-based risk charts	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	60 months after baseline

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Secondary Outcome of Phase I: Change in systolic blood pressure	the change in systolic blood pressure from baseline	24 months after baseline
Secondary Outcome of Phase I: Change in total cholesterol	the change in total cholesterol from baseline	24 months after baseline
Secondary Outcome of Phase I: Change in low-density lipoprotein cholesterol	the change in low-density lipoprotein cholesterol from baseline	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)	60 months after baseline

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	60 months after baseline

Collaborators and Investigators

• Sponsor: Peking University
• Collaborators: Yinzhou District Center for Disease Control and Prevention
• Investigators: Principal Investigator: Xun TANG, PhD, MHS; Principal Investigator: Pei GAO, PhD

Publications and helpful links

General Publications

• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): July 6, 2023
• Primary Completion (Estimated): July 1, 2028
• Study Completion (Estimated): July 1, 2028

Study Registration Dates

• First Submitted: June 16, 2023
• First Submitted That Met QC Criteria: June 16, 2023
• First Posted (Actual): June 26, 2023

Study Record Updates

• Last Update Posted (Actual): November 15, 2024
• Last Update Submitted That Met QC Criteria: November 14, 2024
• Last Verified: November 1, 2024

More Information

Terms related to this study

• Keywords: primary prevention; cluster randomized trial; cardiovascular risk assessment
• Additional Relevant MeSH Terms: Cardiovascular Diseases
• Other Study ID Numbers: IRB00001052-21060

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: According to the Administrative Regulations on Human Genetic Resources issued by the State Council of the People's Republic of China in 2019, we are waiting for the approval of IPD sharing.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No