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

Обзор

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.

Подробное описание

"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."

Вмешательства

• Другое 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

Первичные конечные точки

• Rate of Dual Goal Attainment for Blood Pressure and Lipids [Срок оценки: 12 months after randomization]

Вторичные конечные точки (6)

• Change in Left Ventricular Ejection Fraction (LVEF) [Срок оценки: Baseline and 12 Months]
• Exercise Compliance Rate [Срок оценки: 12 Months]
• Medication Adherence [Срок оценки: 12 Months]
• Smoking Cessation Rate [Срок оценки: 12 Months]
• Quality of Life（EQ-5D-5L） [Срок оценки: 12 Months]
• Major Adverse Cardiovascular Events (MACE) Composite of all-cause death, myocardial infarction, malignant arrhythmia, or hospitalization for heart failure. [Срок оценки: 12 Months]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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)

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Лечение

Центры проведения

Китай · 4 центра

• 13810720787 — Пекин
• Beijing Tongren Hospital, Capital Medical University, Beijing, China — Пекин
• The First Affiliated Hospital of Dalian Medical University, Dalian, China — Dalian
• The First Hospital of Jilin University, Changchun, China — Jilin City

Идентификаторы

NCT: NCT07332494 · KS2025290

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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