The DigiCare-CHD study is an investigator-initiated, multicenter, open-label, parallel-group randomized controlled trial. It aims to evaluated the efficacy of a smartphone-based digital remote management platform compared to usual care in achieving dual goal attainment of blood pressure and LDL-cholesterol levels in patients with coronary heart disease following percutaneous coronary intervention.
Age 18-75 years
Diagnosis of Acute Coronary Syndrome (ACS) or Chronic Coronary Syndrome (CCS)
Status post-successful percutaneous coronary intervention (PCI).
Possession of a smartphone and ability to operate the application (independently or with caregiver assistance).
Heart Failure: NYHA Class III-IV or LVEF < 40%.
Severe hepatic dysfunction (ALT/AST ≥3xULN or Total Bilirubin >1.5 mg/dl)
Severe renal dysfunction (eGFR < 30 ml/min/1.73m² or requiring dialysis)
Uncontrolled hypothyroidism (TSH >1.5xULN or >10 mIU/L, or unstable dosage within 6 weeks)
Parallel
Digital Remote Management Group
Other intervention1-year intervention 1. BP Management: Protocol-driven self-monitoring frequencies. The system triggers alerts for BP \>130/80 mmHg and generates automated suggestions for medication titration, subject to physician approval. 2. Lipid Management: Automated reminders for laboratory testing. Optical Character Recognition (OCR) technology extracts data from lab reports. If LDL-C ≥1.4 mmol/L, the system proposes regimen intensification for physician review. 3. Exercise Management:Target of ≥6000 steps/day. Data is synchronized via wearables or smartphones. Inactivity triggers automated behavioral feedback. 4. Medication Management: Daily app-based reminders and digital "check-ins." Non-adherence triggers automated alerts followed by human intervention if persistent. 5. Symptom Monitoring: Patient-reported outcomes (e.g., chest pain/dyspnea) via the App, with automated triage for risk stratification. 6. Health Education: Push delivery of targeted secondary prevention educational materials.
Rate of Dual Goal Attainment for Blood Pressure and Lipids
Defined as the proportion of patients achieving both SBP \< 130 mmHg and DBP \< 80 mmHg and LDL-C \< 1.4 mmol/L.
Change in Left Ventricular Ejection Fraction (LVEF)
Exercise Compliance Rate
Proportion of patients maintaining an average of ≥6000 steps/day.
Medication Adherence
MARS-10 scale
Smoking Cessation Rate
Self-reported complete abstinence from smoking among baseline smokers
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