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

NCT07332468

RecruitingNA

Sponsor: Beijing Anzhen Hospital

Conditions: Atherosclerotic Cardiovascular Diseases

Interventions: Digital Remote Management Group

Countries: China

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.

Eligibility overview

Sex: ALL

Age: 35 Years to —

Healthy volunteers: No

Study type: INTERVENTIONAL

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.

Locations (5)

Beijing, China
Changchun, China
Dalian, China
Nanchang, China
Shanghai, China