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

Peking University

Status: Enrolling

Conditions: Cardiovascular Diseases

Treatments: Other: Dynamic risk monitoring; Other: Regular GP visits; Other: Frequent and automatic cardiovascular risk assessment

Study type: Interventional

Funder types: Other

Identifiers

NCT05919056

IRB00001052-21060

Details and patient eligibility

About

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.

Full 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.

Enrollment: 22,032 estimated patients

Sex: All

Ages: 40 to 79 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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22,032 participants in 2 patient groups

Intervention arm

Experimental group

Description:

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.

Treatment:

Other: Frequent and automatic cardiovascular risk assessment

Other: Regular GP visits

Other: Dynamic risk monitoring

Control arm

No Intervention group

Description:

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.