Cardiovascular risk assessment and prevention for high-risk adults
Cardiovascular Risk Assessment and dynamIc Monitoring-based Prevention Trial for prImary Care quALity evaLuation in Yinzhou
This study is testing a new way to regularly check and manage heart health in high-risk adults aged 40 to 79 in China to see if it can help prevent heart problems.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 22032 (estimated) |
| Ages | 40 Years to 79 Years |
| Sex | All |
| Sponsor | Peking University Academic / other |
| Locations | 1 site (Ningbo, Zhejiang) |
| Trial ID | NCT05919056 on ClinicalTrials.gov |
What this trial studies
This trial evaluates a risk-based dynamic monitoring strategy aimed at preventing cardiovascular diseases in high-risk adults aged 40 to 79 in Yinzhou District, China. It involves a cluster randomized design where 216 clinics will either implement the intervention, which includes regular cardiovascular risk assessments and monitoring supported by a web-based system, or continue with usual care. The study will assess changes in cardiovascular risk scores over 24 months and track major adverse cardiovascular events over 60 months. The goal is to determine the effectiveness of this comprehensive strategy in reducing cardiovascular risks and events.
Who should consider this trial
Good fit: Ideal candidates are residents of Yinzhou District aged 40 to 79 with a 10-year cardiovascular disease risk of 10% or higher.
Not a fit: Patients with a history of coronary heart disease, stroke, heart failure, or cancer will not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly enhance primary prevention strategies for cardiovascular diseases using digital health technology.
How similar studies have performed: Other studies have shown promise in using digital health technologies for cardiovascular risk management, suggesting potential success for this approach.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Ningbo, Zhejiang
- Yinzhou District Center for Disease Control and Prevention — Ningbo, Zhejiang, China (Recruiting)
Study contacts
- Principal investigator: Xun TANG, PhD, MHS
- Study coordinator: Xun TANG, PhD, MHS
- Email: tangxun@bjmu.edu.cn
- Phone: +86-10-82801528 ext 317
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.