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

NCT07332494 | Not Yet Recruiting DMC

• 1 other identifier: KS2025290
• Study Type: interventional
• Target: 792
• Locations: 1 country
• Sites: 4

Brief 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.

Conditions

Coronary Heart Disease; Percutaneous Coronary Intervention

Outcome Measures

Primary Outcomes (1)

• 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.

  12 months after randomization

Secondary Outcomes (6)

• Change in Left Ventricular Ejection Fraction (LVEF)

  Baseline and 12 Months

• Exercise Compliance Rate

  12 Months

• Medication Adherence

  12 Months

• Smoking Cessation Rate

  12 Months

• Quality of Life（EQ-5D-5L）

  12 Months

Study Arms (2)

Usual care Group

NO INTERVENTION

Patients receive standard post-PCI management, including guideline-directed medical therapy (GDMT) and routine outpatient follow-up visits at 1, 3, 6, 9, and 12 months.

Digital Remote Management Group

EXPERIMENTAL

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.

Other: Digital Remote Management Group

Interventions

Digital Remote Management Group OTHER

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.

Digital Remote Management Group

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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)

Sponsors & Collaborators

• Beijing Anzhen Hospital: lead

Study Sites (4)

13810720787

Beijing, China

Location

Beijing Tongren Hospital, Capital Medical University, Beijing, China

Beijing, China

Location

The First Affiliated Hospital of Dalian Medical University, Dalian, China

Dalian, China

Location

The First Hospital of Jilin University, Changchun, China

Jilin, China

Location

MeSH Terms

Conditions

Coronary Disease

Condition Hierarchy (Ancestors)

Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases

Central Study Contacts

DigiCare-CHD Coordinating Center

CONTACT

13810720787; chshma@vip.sina.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of cardiology department

Study Record Dates

• First Submitted: December 31, 2025
• First Posted: January 12, 2026
• Study Start: January 1, 2026
• Primary Completion (Estimated): July 1, 2027
• Study Completion (Estimated): July 1, 2027
• Last Updated: January 12, 2026

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

CN (4)