Digital Remote Management for Care and Continuous Optimization Versus Usual Care in Patients With Coronary Heart Disease (DigiCare-CHD)
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Digital Remote Management Group.
- Who it may be relevant to
- Registry conditions: Coronary Heart Disease, Percutaneous Coronary Intervention. Basic parameters: 18 years — 75 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Overview
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."
Interventions
- 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 step
Primary outcome measures
- Rate of Dual Goal Attainment for Blood Pressure and Lipids [Time frame: 12 months after randomization]
Secondary outcome measures (6)
- Change in Left Ventricular Ejection Fraction (LVEF) [Time frame: Baseline and 12 Months]
- Exercise Compliance Rate [Time frame: 12 Months]
- Medication Adherence [Time frame: 12 Months]
- Smoking Cessation Rate [Time frame: 12 Months]
- Quality of Life（EQ-5D-5L） [Time frame: 12 Months]
- Major Adverse Cardiovascular Events (MACE) Composite of all-cause death, myocardial infarction, malignant arrhythmia, or hospitalization for heart failure. [Time frame: 12 Months]
Eligibility criteria
Inclusion criteria
- 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).
- Provision of written informed consent.
Exclusion criteria
- 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)
- Life expectancy < 1 year due to non-cardiovascular comorbidities
- Severe sensory (hearing/vision) or cognitive impairment precluding device use
- Conditions affecting adherence (e.g., substance use disorder, history of alcohol abuse)
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Single blind
- Primary purpose
- Treatment
Study locations
China · 4 centers
- 13810720787 — Beijing
- Beijing Tongren Hospital, Capital Medical University, Beijing, China — Beijing
- The First Affiliated Hospital of Dalian Medical University, Dalian, China — Dalian
- The First Hospital of Jilin University, Changchun, China — Jilin City
Identifiers
NCT: NCT07332494 · KS2025290