Atherosclerotic Cardiovascular DiseasesNCT07332468
Digital Remote Management for Care and Continuous Optimization Versus Usual Care to Reduce Risk of Atherosclerotic Cardiovascular Diseases (DigiCare-preASCVD)
A study testing Digital Remote Management Group in people with Atherosclerotic Cardiovascular Diseases, run by Beijing Anzhen Hospital at 5 sites in China.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 35 years and older
- Conditions the study is for
- Atherosclerotic Cardiovascular Diseases
- What is being tested?
- Digital Remote Management Group
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 564 participants
- Where
- 5 sitesChina
- Study dates
- 25 Feb 2026to Apr 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 35 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
5 sites in 1 country. Contact the study team or a site near you to ask about taking part.
5 sites in 1 country
China5 sites, 5 recruiting
- Recruiting
Beijing Anzhen Hospital, Capital Medical University, Beijing, China
Beijing
Liu He, +86 13810720787, theliu@139.com
- Recruiting
The First Hospital of Jilin University, Changchun, China
Changchun
Qian Tong, +86 13074337289, tongqian187@aliyun.com
- Recruiting
The First Affiliated Hospital of Dalian Medical University, Dalian, China
Dalian
Rongfeng Zhang, +86 18098875798, zrf0088@126.com
- Recruiting
The Second Affiliated Hospital of Nanchang University, Nanchang, China
Nanchang
Kui Hong, +86 13979111788, hongkui88@163.com
- Recruiting
Ruijin Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai, China
Shanghai
Jiguang Wang, +86 13764189476, wjg11284@rjh.com.cn
About this study
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.
Read the detailed description
"Atherosclerotic cardiovascular disease (ASCVD) is a leading global cause of mortality. Primary care is central to its prevention within tiered healthcare systems, yet faces challenges including physician training gaps and inefficient specialist referrals. Digital remote interventions offer a promising solution due to widespread smartphone/internet access, enabling convenient care and real-time data use. Current tools focus on patient education/reminders or clinical decision support (CDSS) separately. However, effective long-term ASCVD management requires an integrated system that combines CDSS-guided treatment with comprehensive, sustained risk-factor monitoring (e.g., blood pressure, lipids). This study aims to develop and validate such an integrated remote management platform to overcome multi-level barriers, disseminate advanced resources to primary care, and enhance equitable cardiovascular risk prevention.
The DigiCare-ASCVD Study is a multicenter, open-label, randomized controlled trial with a 1:1 parallel-group design. It will enroll 564 patients at high risk for ASCVD. All enrolled patients will be randomly assigned in a 1:1 ratio to either the Digital Remote Management group or the usual care group.
Patients in the Digital Remote Management group will utilize a smartphone-based ""physician-machine collaboration"" platform. This system integrates home monitoring to track BP, lipids, glucose, medication compliance and physical activity. It features AI-driven alerts for abnormal values, automated medication adjustment suggestions (verified by physicians), and targeted health education The primary endpoint is the mean change in the patient's 10-year ASCVD risk, calculated using the China-PAR risk prediction model, from baseline to the 12-month follow-up."
- Conditions
- Atherosclerotic Cardiovascular Diseases
- Being tested
- Digital Remote Management Group
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Digital Remote Management GroupOther
In addition to usual care, patients receive a 1-year intervention via a smartphone-based ""physician-machine collaboration"" platform：
- 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.
- 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.
- 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.
- Medication Management: Daily app-based reminders and clock-in tasks. Non-adherence triggers automated reminders and human follow-up.
- Health Education: Regular push of targeted articles/videos on secondary prevention。
| Study group | Role | What they receive |
|---|---|---|
| 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, 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. Receives: Other: Digital Remote Management Group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean change in the patient's 10-year ASCVD risk, calculated using the China-PAR risk prediction model
Measured: From Baseline to 12 Months
Secondary outcomes (8)
Control Rate of Systolic Blood Pressure (SBP)
SBP < 130 mmHg at 12 months
Measured: 12 Months
Control Rate of Diastolic Blood Pressure (DBP)
DBP < 80 mmHg at 12 months
Measured: 12 Months
Mean change in SBP compared to baseline
Measured: From Baseline to 12 Months
Mean change in DBP compared to baseline
Measured: From Baseline to 12 Months
Mean change in fasting blood glucose compared to baseline
Measured: From Baseline to 12 Months
Mean change in low-density lipoprotein compared to baseline
Measured: From Baseline to 12 Months
Overweight or Obesity Rate compared to Baseline
Measured: From Baseline to 12 Months
Current Smoking Rate compared to Baseline
Measured: From Baseline to 12 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jan 2026
- Study start25 Feb 2026
- Primary completionJan 2028 (estimated)
- Study completionApr 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Atherosclerotic Cardiovascular DiseasesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 564 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Beijing Anzhen Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Chang sheng Ma, Beijing Anzhen Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07332468
- Sponsor's protocol ID
- KS2025288
- Status last verified
- Aug 2026
- First submitted
- 31 Dec 2025
- Last updated
- 19 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Digital Remote Management for Care and Continuous Optimization Versus Usual Care to Reduce Risk of Atherosclerotic Cardiovascular Diseases (DigiCare-preASCVD)
- ClinicalTrials.gov ID
- NCT07332468
- Acronym / sponsor ID
- KS2025288
- Conditions
- Atherosclerotic Cardiovascular Diseases
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 564 participants (estimated)
- Lead sponsor
- Beijing Anzhen HospitalUniversity, hospital or other
- Study start
- 25 Feb 2026 (actual)
- Primary completion
- Jan 2028 (estimated)
- Study completion
- Apr 2028 (estimated)
- First posted
- 12 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
"Atherosclerotic cardiovascular disease (ASCVD) is a leading global cause of mortality. Primary care is central to its prevention within tiered healthcare systems, yet faces challenges including physician training gaps and inefficient specialist referrals. Digital remote interventions offer a promising solution due to widespread smartphone/internet access, enabling convenient care and real-time data use. Current tools focus on patient education/reminders or clinical decision support (CDSS) separately. However, effective long-term ASCVD management requires an integrated system that combines CDSS-guided treatment with comprehensive, sustained risk-factor monitoring (e.g., blood pressure, lipids). This study aims to develop and validate such an integrated remote management platform to overcome multi-level barriers, disseminate advanced resources to primary care, and enhance equitable cardiovascular risk prevention.
The DigiCare-ASCVD Study is a multicenter, open-label, randomized controlled trial with a 1:1 parallel-group design. It will enroll 564 patients at high risk for ASCVD. All enrolled patients will be randomly assigned in a 1:1 ratio to either the Digital Remote Management group or the usual care group.
Patients in the Digital Remote Management group will utilize a smartphone-based ""physician-machine collaboration"" platform. This system integrates home monitoring to track BP, lipids, glucose, medication compliance and physical activity. It features AI-driven alerts for abnormal values, automated medication adjustment suggestions (verified by physicians), and targeted health education The primary endpoint is the mean change in the patient's 10-year ASCVD risk, calculated using the China-PAR risk prediction model, from baseline to the 12-month follow-up."
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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, 12 months. |
| Digital Remote Management Group | Experimental | Other: Digital Remote Management GroupIn 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. |
Who may qualify
- Ages
- 35 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Digital Remote Management GroupIn 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 |
Primary outcome
Mean change in the patient's 10-year ASCVD risk, calculated using the China-PAR risk prediction model
Time frame: From Baseline to 12 Months
8 secondary outcomes
Control Rate of Systolic Blood Pressure (SBP)
Time frame: 12 Months
Control Rate of Diastolic Blood Pressure (DBP)
Time frame: 12 Months
Mean change in SBP compared to baseline
Time frame: From Baseline to 12 Months
Mean change in DBP compared to baseline
Time frame: From Baseline to 12 Months
Mean change in fasting blood glucose compared to baseline
Time frame: From Baseline to 12 Months
Mean change in low-density lipoprotein compared to baseline
Time frame: From Baseline to 12 Months
Overweight or Obesity Rate compared to Baseline
Time frame: From Baseline to 12 Months
Current Smoking Rate compared to Baseline
Time frame: From Baseline to 12 Months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Aug 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Digital Remote Management Group in people with Atherosclerotic Cardiovascular Diseases, run by Beijing Anzhen Hospital at 5 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 19 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Liu He (+86 13810720787, theliu@139.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mean change in the patient's 10-year ASCVD risk, calculated using the China-PAR risk prediction model (time frame: From Baseline to 12 Months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Aug 2026.