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

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age35+
SponsorBeijing Anzhen Hospital

About this trial

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.

Eligibility criteria

Qualifiers

10-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

Disqualifiers

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

Trial design

Treatments tested in this trial

  • Digital Remote Management Group

Treatment groups

790 Participants
are divided into 2 treatment groups

Locations

5
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

Sponsors and collaborators

Beijing Anzhen Hospital

Lead sponsor