Cardiovascular Risk Assessment and dynamIc Monitoring-based Prevention Trial for prImary Care quALity evaLuation in Yinzhou
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Cardiovascular Diseases
- Sponsor
- Peking University
- Enrollment
- 22032
- Locations
- 1
- Primary Endpoint
- Primary Outcome of Phase I: Change in cardiovascular risk score
- Status
- Recruiting
- Last Updated
- last year
Overview
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.
Investigators
Pei Gao
Professor
Peking University
Eligibility Criteria
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
Outcomes
Primary Outcomes
Primary Outcome of Phase I: Change in cardiovascular risk score
Time Frame: 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)
Time Frame: 60 months after baseline
Incidence of coronary heart disease, stroke, heart failure and all-cause mortality
Secondary Outcomes
- Secondary Outcome of Phase II: Change in health-related quality of life(60 months after baseline)
- 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)