The DigiCare-preASCVD study is an investigator-initiated, multicenter, open-label, parallel-group randomized controlled trial. It aims to evaluated whether digital remote management is superior to usual care in reducing risk of atherosclerotic cardiovascular diseases and improving blood pressure control, glycemic control, lipids control, medication compliance and lifestyle.
10-year ASCVD risk ≥ 10%, calculated using the China-PAR risk prediction model
Adultd aged ≥ 35 years
Able to use a smartphone (or assisted by family) and agrees to remote management
Signed informed consent
History of acute myocardial infarction, stroke, heart failure, malignant arrhythmia, or prior percutaneous coronary intervention or coronary artery bypass grafting surgery
Moderate to severe hepatic dysfunction (Child-Pugh class B-C)
CKD stages 4-5 (eGFR <30 ml/min/1.73m²) or on dialysis
Chronic obstructive pulmonary disease requiring ongoing home oxygen therapy or chronic oral steroid therapy as an outpatient
Parallel
Digital Remote Management Group
Other interventionIn addition to usual care, patients receive a 1-year intervention via a smartphone-based ""physician-machine collaboration"" platform： 1. BP Management: Daily or weekly self-monitoring based on control status. System triggers alerts for BP \>130/80 mmHg and generates medication adjustment suggestions for physician approval. 2. Lipid Management: Reminder for lab tests. OCR technology parses results. If LDL-C ≥2.6 mmol/L, the system suggests regimen intensification for physician review. 3. Blood Glucose Management: Reminder for lab tests. OCR technology parses results.If Fasting Blood Glucose (FBG) ≥6.1 mmol/L for patients without diabetes and FBG ≥7.0 mmol/L for patients with diabetes, the system suggests regimen intensification for physician review. 4. Medication Management: Daily app-based reminders and clock-in tasks. Non-adherence triggers automated reminders and human follow-up. 5. Health Education: Regular push of targeted articles/videos on secondary prevention。
Mean change in the patient's 10-year ASCVD risk, calculated using the China-PAR risk prediction model
Control Rate of Systolic Blood Pressure (SBP)
SBP \< 130 mmHg at 12 months
Control Rate of Diastolic Blood Pressure (DBP)
DBP \< 80 mmHg at 12 months
Mean change in SBP compared to baseline
Mean change in DBP compared to baseline
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