Digital remote management to reduce ASCVD risk in high-risk adults

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This multicenter, open-label, randomized trial will compare a digital remote management platform to usual care in 564 adults at elevated ASCVD risk. Participants in the digital group use a smartphone-based system that tracks blood pressure, lipids, glucose, medication adherence, and physical activity, with AI-driven alerts to help guide treatment. The study focuses on integrated risk-factor monitoring and decision support to improve long-term cardiovascular management in primary care settings. Primary endpoints include reductions in ASCVD risk and improvements in blood pressure, glycemic control, lipid levels, and medication adherence. The trial is conducted in China across multiple centers led by Beijing Anzhen Hospital.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. 10-year ASCVD risk ≥ 10%, calculated using the China-PAR risk prediction model
2. Adultd aged ≥ 35 years
3. Able to use a smartphone (or assisted by family) and agrees to remote management
4. Signed informed consent

Exclusion Criteria:

1. History of acute myocardial infarction, stroke, heart failure, malignant arrhythmia, or prior percutaneous coronary intervention or coronary artery bypass grafting surgery
2. Moderate to severe hepatic dysfunction (Child-Pugh class B-C)
3. CKD stages 4-5 (eGFR \<30 ml/min/1.73m²) or on dialysis
4. Chronic obstructive pulmonary disease requiring ongoing home oxygen therapy or chronic oral steroid therapy as an outpatient
5. Pregnant, planning to become pregnant within the next 12 months
6. Life expectancy \<12 months (e.g., advanced malignancy, etc.);
7. Cognitive impairment or communication disorder.

Where it's running

• Beijing Anzhen Hospital, Capital Medical University, Beijing, China
  Beijing, China Recruiting
• The First Hospital of Jilin University, Changchun, China
  Changchun, China Recruiting
• The First Affiliated Hospital of Dalian Medical University, Dalian, China
  Dalian, China Recruiting
• The Second Affiliated Hospital of Nanchang University, Nanchang, China
  Nanchang, China Recruiting
• Ruijin Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai, China
  Shanghai, China Recruiting

Study contacts

• Study coordinator: Liu He
• Email: theliu@139.com
• Phone: +86 13810720787

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.