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

NCT ID: NCT07332494

Last Updated: 2026-01-12

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 792 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2026-01-31
• Study Completion Date: 2027-07-31

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.

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Usual care Group

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.

Group Type: NO_INTERVENTION

No interventions assigned to this 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.

Group Type: EXPERIMENTAL

Digital Remote Management Group

Intervention Type: 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.

Interventions

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.

Intervention Type: OTHER

Eligibility Criteria

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)

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Beijing Anzhen Hospital

OTHER

Sponsor Role: lead

Responsible Party

Chang sheng Ma

Director of cardiology department

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

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, , China

Countries

China

Central Contacts

DigiCare-CHD Coordinating Center

Role: CONTACT

chshma@vip.sina.com

13810720787

Other Identifiers

KS2025290

Identifier Type: -

Identifier Source: org_study_id