NCT07332494

Digital Remote Management for Care and Continuous Optimization Versus Usual Care in Patients With Coronary Heart Disease (DigiCare-CHD)

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 792 (estimated)
• Sponsor: Beijing Anzhen Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

"Coronary heart disease (CHD) remains a leading cause of global mortality. While percutaneous coronary intervention (PCI) significantly improves acute survival, patients continue to face substantial residual cardiovascular risk driven by the progression of systemic atherosclerosis. Rigorous management of blood pressure (BP) and low-density lipoprotein cholesterol (LDL-C) is imperative for secondary prevention. However, achieving simultaneous targets (BP \< 130/80 mmHg and LDL-C \< 1.4 mmol/L) in real-world practice is challenging due to clinical inertia and suboptimal patient adherence. Traditional outpatient follow-up is often fragmented and reactive, failing to provide the continuous monitoring required for optimal risk factor control. The DigiCare-CHD trial serves as a prospective, multicenter, open-label randomized controlled trial designed to enroll 792 patients who have successfully undergone PCI for acute or chronic coronary syndromes. Participants will be randomized 1:1 to either the Digital Remote Management group or the Usual Care group, with a follow-up period of 12 months. Patients in the intervention arm will utilize a digital remote management platform. This system integrates home monitoring to track BP, lipid profiles, and physical activity. Key features include AI-driven alerts for abnormal values, automated decision support for medication titration (verified by physicians), and targeted health education. The primary endpoint is the rate of dual goal attainment for BP and LDL-C at 12 months. DigiCare-CHD aims to establish a proactive, closed-loop management strategy to effectively reduce residual cardiovascular risk and improve long-term prognosis in the post-PCI population."

Conditions

• Coronary Heart Disease
• Percutaneous Coronary Intervention

Interventions

Type	Name	Description
OTHER	Digital Remote Management Group	1-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.

Timeline

• Start date: 2026-01-01
• Primary completion: 2027-07-01
• Completion: 2027-07-01
• First posted: 2026-01-12
• Last updated: 2026-01-12

Locations

4 sites across 1 country: China