Cardiovascular Risk Assessment and Dynamic Monitoring-based Prevention Trial

NCT05919056 | Recruiting DMC

• 1 other identifier: IRB00001052-21060
• Study Type: interventional
• Target: 22,032
• Locations: 1 country
• Sites: 1

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.

Conditions

Cardiovascular Diseases

Keywords

primary prevention; cluster randomized trial; cardiovascular risk assessment

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (4)

• Secondary Outcome of Phase I: Change in systolic blood pressure

  24 months after baseline

• Secondary Outcome of Phase I: Change in total cholesterol

  24 months after baseline

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

  24 months after baseline

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

  60 months after baseline

Other Outcomes (1)

• Other Pre-specified Outcome of Phase II: Incremental cost-effectiveness ratio (ICER)

  60 months after baseline

Study Arms (2)

Intervention arm

EXPERIMENTAL

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; Other: Dynamic risk monitoring; Other: Regular GP visits

Control arm

NO INTERVENTION

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.

Interventions

Frequent and automatic cardiovascular risk assessment OTHER

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.

Intervention arm

Dynamic risk monitoring OTHER

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).

Intervention arm

Regular GP visits OTHER

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").

Intervention arm

Eligibility Criteria

• Age: 40 Years - 79 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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%);

You may not qualify if:

• Have a history of coronary heart disease, stroke or heart failure;
• Patients with a diagnosis of cancer;
• Refused to provide written informed consent

Sponsors & Collaborators

• Peking University: lead
• Yinzhou District Center for Disease Control and Prevention: collaborator

Study Sites (1)

Yinzhou District Center for Disease Control and Prevention

Ningbo, Zhejiang, 315100, China

RECRUITING

Related Publications (3)

• 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.

  PMID: 29440217 BACKGROUND

• 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.

  BACKGROUND

• 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.

  PMID: 36340248 BACKGROUND

MeSH Terms

Conditions

Cardiovascular Diseases

Study Officials

• Xun TANG, PhD, MHS

  PRINCIPAL INVESTIGATOR

• Pei GAO, PhD

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Xun TANG, PhD, MHS

CONTACT

+86-10-82801528 ext 317; tangxun@bjmu.edu.cn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: June 16, 2023
• First Posted: June 26, 2023
• Study Start: July 6, 2023
• Primary Completion (Estimated): July 1, 2028
• Study Completion (Estimated): July 1, 2028
• Last Updated: November 15, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)