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

NCT07332494 · tracked via the Priya Life Science China tracker

Sponsor

Beijing Anzhen Hospital

Phase

Not applicable

Started

2026-01

Last updated

2026-01-12

Condition(s) studied

Coronary Heart DiseasePercutaneous Coronary Intervention

Investigational drug(s) / intervention(s)

Digital Remote Management Group

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.

Study 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.

Eligibility

Sex

ALL

Min age

18 Years

Max age

75 Years

Healthy volunteers

Inclusion Criteria: 1. Age 18-75 years 2. Diagnosis of Acute Coronary Syndrome (ACS) or Chronic Coronary Syndrome (CCS) 3. Status post-successful percutaneous coronary intervention (PCI). 4. Possession of a smartphone and ability to operate the application (independently or with caregiver assistance). 5. Provision of written informed consent. Exclusion Criteria: 1. Heart Failure: NYHA Class III-IV or LVEF \< 40%. 2. Severe hepatic dysfunction (ALT/AST ≥3xULN or Total Bilirubin \>1.5 mg/dl) 3. Severe renal dysfunction (eGFR \< 30 ml/min/1.73m² or requiring dialysis) 4. Uncontrolled hypothyroidism (TSH \>1.5xULN or \>10 mIU/L, or unstable dosage within 6 weeks) 5. Life expectancy \< 1 year due to non-cardiovascular comorbidities 6. Severe sensory (hearing/vision) or cognitive impairment precluding device use 7. Conditions affecting adherence (e.g., substance use disorder, history of alcohol abuse)

Primary outcome measure(s)

Rate of Dual Goal Attainment for Blood Pressure and Lipids — 12 months after randomization
Defined as the proportion of patients achieving both SBP \< 130 mmHg and DBP \< 80 mmHg and LDL-C \< 1.4 mmol/L.

Trial sites (4)

Facility	City	Region
13810720787	Beijing	China
Beijing Tongren Hospital, Capital Medical University, Beijing, China	Beijing	China
The First Affiliated Hospital of Dalian Medical University, Dalian, China	Dalian	China
The First Hospital of Jilin University, Changchun, China	Jilin City	China

More Beijing Anzhen Hospital trials in China

Helium-free Magnetocardiography Guided Therapy for Stable Coronary Artery Disease - A Randomized Controlled Trial Recruiting

Early Intra-aortic Balloon Pump Use After Venoarterial Extracorporeal Membrane Oxygenation Recruiting

China Extracorporeal Life Support Registry Recruiting

Wellbeing and Survival Improvement With Event Reduction by Ablation for Atrial Fibrillation in the Very Elderly Recruiting

Intravenous Thrombolysis Combined With Tirofiban in Acute Ischemic Stroke Recruiting

Other trials for the same condition

Anti-platelet Effect of Berberine in Patients After Percutaneous Coronary Intervention Recruiting

Effect of Individualized Exercise in Elderly Patients With Coronary Heart Disease Recruiting

NOAC Therapy Guided by PARIS Risk Score and D-dimer in Patients With ACS After PCI Recruiting

IVUS-FFR Accuracy for Coronary Stenosis Recruiting

Protective Effect of PCSK9 Inhibitor Against Negative Inflammatory Response and Organ Dysfunction After Coronary Artery Bypass Grafting (PANDA VIII) Starting soon

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07332494 on ClinicalTrials.gov ↗ ← All trials in China