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

NCT07332468 | Not Yet Recruiting DMC

• 1 other identifier: KS2025288
• Study Type: interventional
• Target: 790
• Locations: 1 country
• Sites: 5

Brief Summary

The DigiCare-ASCVD 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.

Conditions

Atherosclerotic Cardiovascular Diseases

Outcome Measures

Primary Outcomes (1)

• Mean change in the patient's 10-year ASCVD risk, calculated using the China-PAR risk prediction model

  12 Months

Secondary Outcomes (6)

• Mean change in the patient's lifetime ASCVD risk, calculated using the China-PAR risk prediction model.

  Baseline and 12 Months

• Simultaneous Control Rate of Blood Pressure

  12 Months

• Mean change in SBP and DBP compared to baseline

  12 Months

• Overweight or Obesity Rate

  12 Months

• Smoking Cessation Rate

  12 Months

Study Arms (2)

Usual care Group

NO INTERVENTION

Usual Care Group: Patients receive standard BP, lipids,glucose and physical activity management including guideline-directed medication and outpatient follow-up at 3, 6, 9, 12 months.

Digital Remote Management Group

EXPERIMENTAL

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。

Other: Digital Remote Management Group

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。

Digital Remote Management Group

Eligibility Criteria

• Age: 35 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• year ASCVD risk ≥ 10%, calculated using the China-PAR risk prediction model
• Adultd aged ≥ 35 years
• Able to use a smartphone (or assisted by family) and agrees to remote management
• Signed informed consent

You may not qualify if:

• History of acute myocardial infarction, stroke, heart failure, malignant arrhythmia, or prior percutaneous coronary intervention or coronary artery bypass grafting surgery
• Moderate to severe hepatic dysfunction (Child-Pugh class B-C)
• CKD stages 4-5 (eGFR \<30 ml/min/1.73m²) or on dialysis
• Chronic obstructive pulmonary disease requiring ongoing home oxygen therapy or chronic oral steroid therapy as an outpatient
• Pregnant, planning to become pregnant within the next 12 months
• Life expectancy \<12 months (e.g., advanced malignancy, etc.);
• Cognitive impairment or communication disorder.

Sponsors & Collaborators

• Beijing Anzhen Hospital: lead

Study Sites (5)

Beijing Anzhen Hospital, Capital Medical University, Beijing, China

Beijing, China

Location

The First Hospital of Jilin University, Changchun, China

Changchun, China

Location

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

Dalian, China

Location

The Second Affiliated Hospital of Nanchang University, Nanchang, China

Nanchang, China

Location

Ruijin Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai, China

Shanghai, China

Location

Central Study Contacts

Liu He

CONTACT

13810720787; theliu@139.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): March 1, 2027
• Study Completion (Estimated): April 1, 2027
• Last Updated: January 12, 2026

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

CN (5)