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Digital Remote Management for Care and Continuous Optimization Versus Usual Care to Reduce Risk of Atherosclerotic Cardiovascular Diseases (DigiCare-preASCVD)

Sponsor: Beijing Anzhen Hospital • ClinicalTrials.gov ID: NCT07332468

Registry updated: 2026-08-19

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Description

The DigiCare-preASCVD study is an investigator-initiated, multicenter, open-label, parallel-group randomized controlled trial. It aims to evaluated whether digital remote management is superior to usual care in reducing risk of atherosclerotic cardiovascular diseases and improving blood pressure control, glycemic control, lipids control, medication compliance and lifestyle.

Interventions

Digital Remote Management Group (Other)
In addition to usual care, patients receive a 1-year intervention via a smartphone-based ""physician-machine collaboration"" platform： 1. BP Management: Daily or weekly self-monitoring based on control status. System triggers alerts for BP \>130/80 mmHg and generates medication adjustment suggestions for physician approval. 2. Lipid Management: Reminder for lab tests. OCR technology parses results. If LDL-C ≥2.6 mmol/L, the system suggests regimen intensification for physician review. 3. Blood Glucose Management: Reminder for lab tests. OCR technology parses results.If Fasting Blood Glucose (FBG) ≥6.1 mmol/L for patients without diabetes and FBG ≥7.0 mmol/L for patients with diabetes, the system suggests regimen intensification for physician review. 4. Medication Management: Daily app-based reminders and clock-in tasks. Non-adherence triggers automated reminders and human follow-up. 5. Health Education: Regular push of targeted articles/videos on secondary prevention。

Eligibility criteria

Inclusion Criteria: 1. 10-year ASCVD risk ≥ 10%, calculated using the China-PAR risk prediction model 2. Adultd aged ≥ 35 years 3. Able to use a smartphone (or assisted by family) and agrees to remote management 4. Signed informed consent Exclusion Criteria: 1. History of acute myocardial infarction, stroke, heart failure, malignant arrhythmia, or prior percutaneous coronary intervention or coronary artery bypass grafting surgery 2. Moderate to severe hepatic dysfunction (Child-Pugh class B-C) 3. CKD stages 4-5 (eGFR \<30 ml/min/1.73m²) or on dialysis 4. Chronic obstructive pulmonary disease requiring ongoing home oxygen therapy or chronic oral steroid therapy as an outpatient 5. Pregnant, planning to become pregnant within the next 12 months 6. Life expectancy \<12 months (e.g., advanced malignancy, etc.); 7. Cognitive impairment or communication disorder.

Conditions

Atherosclerotic Cardiovascular Diseases

Locations

Beijing Anzhen Hospital, Capital Medical University, Beijing, China — Beijing, China
The First Hospital of Jilin University, Changchun, China — Changchun, China
The First Affiliated Hospital of Dalian Medical University, Dalian, China — Dalian, China
The Second Affiliated Hospital of Nanchang University, Nanchang, China — Nanchang, China
Ruijin Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai, China — Shanghai, China

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Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

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