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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.
"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."
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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:
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Digital Remote Management Group | Other | 1-year intervention
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Left Ventricular Ejection Fraction (LVEF) | Baseline and 12 Months | |
| Exercise Compliance Rate | Proportion of patients maintaining an average of ≥6000 steps/day. | 12 Months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| DigiCare-CHD Coordinating Center | Contact | 13810720787 | chshma@vip.sina.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| 13810720787 | Beijing | China | ||||
| Beijing Tongren Hospital, Capital Medical University, Beijing, China |
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|
| Medication Adherence | MARS-10 scale | 12 Months |
| Smoking Cessation Rate | Self-reported complete abstinence from smoking among baseline smokers | 12 Months |
| Quality of Life(EQ-5D-5L) | EQ-5D-5L | 12 Months |
| Major Adverse Cardiovascular Events (MACE) Composite of all-cause death, myocardial infarction, malignant arrhythmia, or hospitalization for heart failure. | 12 Months |
| 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 |
| ID | Term |
|---|---|
| D003327 | Coronary Disease |
| ID | Term |
|---|---|
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D014652 | Vascular Diseases |
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