Coronary Heart DiseaseDigiCare-CHDNCT07332494
Digital Remote Management for Care and Continuous Optimization Versus Usual Care in Patients With Coronary Heart Disease (DigiCare-CHD)
A study testing Digital Remote Management Group in people with Coronary Heart Disease and Percutaneous Coronary Intervention, run by Beijing Anzhen Hospital at 4 sites in China.
Trial summary
The DigiCare-CHD study is an investigator-initiated, multicenter, open-label, parallel-group randomized controlled trial. It aims to evaluated the efficacy of a smartphone-based digital remote management platform compared to usual care in achieving dual goal attainment of blood pressure and LDL-cholesterol levels in… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Coronary Heart Disease, Percutaneous Coronary Intervention
- What is being tested?
- Digital Remote Management Group
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 792 participants
- Where
- 4 sitesChina
- Study dates
- Jan 2026to Jul 2027
- 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 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18-75 years
- Diagnosis of Acute Coronary Syndrome (ACS) or Chronic Coronary Syndrome (CCS)
- Status post-successful percutaneous coronary intervention (PCI).
- Possession of a smartphone and ability to operate the application (independently or with caregiver assistance).
- Provision of written informed consent.
Who cannot join
- Heart Failure: NYHA Class III-IV or LVEF < 40%.
- Severe hepatic dysfunction (ALT/AST ≥3xULN or Total Bilirubin >1.5 mg/dl)
- Severe renal dysfunction (eGFR < 30 ml/min/1.73m² or requiring dialysis)
- Uncontrolled hypothyroidism (TSH >1.5xULN or >10 mIU/L, or unstable dosage within 6 weeks)
- Life expectancy < 1 year due to non-cardiovascular comorbidities
- Severe sensory (hearing/vision) or cognitive impairment precluding device use
- Conditions affecting adherence (e.g., substance use disorder, history of alcohol abuse)
Trial locations and contacts
4 sites in 1 country. Contact the study team or a site near you to ask about taking part.
China4 sites
13810720787
Beijing
Beijing Tongren Hospital, Capital Medical University, Beijing, China
Beijing
The First Affiliated Hospital of Dalian Medical University, Dalian, China
Dalian
The First Hospital of Jilin University, Changchun, China
Jilin City
About this study
The DigiCare-CHD study is an investigator-initiated, multicenter, open-label, parallel-group randomized controlled trial. It aims to evaluated the efficacy of a smartphone-based digital remote management platform compared to usual care in achieving dual goal attainment of blood pressure and LDL-cholesterol levels in patients with coronary heart disease following percutaneous coronary intervention.
Read the detailed description
"Coronary heart disease (CHD) remains a leading cause of global mortality. While percutaneous coronary intervention (PCI) significantly improves acute survival, patients continue to face substantial residual cardiovascular risk driven by the progression of systemic atherosclerosis. Rigorous management of blood pressure (BP) and low-density lipoprotein cholesterol (LDL-C) is imperative for secondary prevention. However, achieving simultaneous targets (BP < 130/80 mmHg and LDL-C < 1.4 mmol/L) in real-world practice is challenging due to clinical inertia and suboptimal patient adherence. Traditional outpatient follow-up is often fragmented and reactive, failing to provide the continuous monitoring required for optimal risk factor control.
The DigiCare-CHD trial serves as a prospective, multicenter, open-label randomized controlled trial designed to enroll 792 patients who have successfully undergone PCI for acute or chronic coronary syndromes. Participants will be randomized 1:1 to either the Digital Remote Management group or the Usual Care group, with a follow-up period of 12 months.
Patients in the intervention arm will utilize a digital remote management platform. This system integrates home monitoring to track BP, lipid profiles, and physical activity. Key features include AI-driven alerts for abnormal values, automated decision support for medication titration (verified by physicians), and targeted health education. The primary endpoint is the rate of dual goal attainment for BP and LDL-C at 12 months. DigiCare-CHD aims to establish a proactive, closed-loop management strategy to effectively reduce residual cardiovascular risk and improve long-term prognosis in the post-PCI population."
- Being tested
- Digital Remote Management Group
- Medical subject headings
- Coronary Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Digital Remote Management GroupOther
1-year intervention
- BP Management: Protocol-driven self-monitoring frequencies. The system triggers alerts for BP >130/80 mmHg and generates automated suggestions for medication titration, subject to physician approval.
- Lipid Management: Automated reminders for laboratory testing. Optical Character Recognition (OCR) technology extracts data from lab reports. If LDL-C ≥1.4 mmol/L, the system proposes regimen intensification for physician review.
- Exercise Management:Target of ≥6000 steps/day. Data is synchronized via wearables or smartphones. Inactivity triggers automated behavioral feedback.
- Medication Management: Daily app-based reminders and digital "check-ins." Non-adherence triggers automated alerts followed by human intervention if persistent.
- Symptom Monitoring: Patient-reported outcomes (e.g., chest pain/dyspnea) via the App, with automated triage for risk stratification.
- Health Education: Push delivery of targeted secondary prevention educational materials.
| Study group | Role | What they receive |
|---|---|---|
| Usual care Group | No intervention | Patients receive standard post-PCI management, including guideline-directed medical therapy (GDMT) and routine outpatient follow-up visits at 1, 3, 6, 9, and 12 months. |
| Digital Remote Management Group | Experimental | 1-year intervention:
1. BP Management: Protocol-driven self-monitoring frequencies. The system triggers alerts for BP >130/80 mmHg and generates automated suggestions for medication titration, subject to physician approval.
2. Lipid Management: Automated reminders for laboratory testing. Optical Character Recognition (OCR) technology extracts data from lab reports. If LDL-C ≥1.4 mmol/L, the system proposes regimen intensification for physician review.
3. Exercise Management:Target of ≥6000 steps/day. Data is synchronized via wearables or smartphones. Inactivity triggers automated behavioral feedback.
4. Medication Management: Daily app-based reminders and digital "check-ins." Non-adherence triggers automated alerts followed by human intervention if persistent.
5. Symptom Monitoring: Patient-reported outcomes (e.g., chest pain/dyspnea) via the App, with automated triage for risk stratification.
6. Health Education: Push delivery of targeted secondary prevention educational materials. Receives: Other: Digital Remote Management Group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of Dual Goal Attainment for Blood Pressure and Lipids
Defined as the proportion of patients achieving both SBP < 130 mmHg and DBP < 80 mmHg and LDL-C < 1.4 mmol/L.
Measured: 12 months after randomization
Secondary outcomes (6)
Change in Left Ventricular Ejection Fraction (LVEF)
Measured: Baseline and 12 Months
Exercise Compliance Rate
Proportion of patients maintaining an average of ≥6000 steps/day.
Measured: 12 Months
Medication Adherence
MARS-10 scale
Measured: 12 Months
Smoking Cessation Rate
Self-reported complete abstinence from smoking among baseline smokers
Measured: 12 Months
Quality of Life（EQ-5D-5L）
EQ-5D-5L
Measured: 12 Months
Major Adverse Cardiovascular Events (MACE) Composite of all-cause death, myocardial infarction, malignant arrhythmia, or hospitalization for heart failure.
Measured: 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 startJan 2026 (estimated)
- Primary completionJul 2027 (estimated)
- Study completionJul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary Heart DiseaseStudies 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
- 792 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
- NCT07332494
- Sponsor's protocol ID
- KS2025290
- Acronym
- DigiCare-CHD
- Status last verified
- Dec 2025
- First submitted
- 31 Dec 2025
- Last updated
- 12 Jan 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 12 Jan 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 in Patients With Coronary Heart Disease (DigiCare-CHD)
- ClinicalTrials.gov ID
- NCT07332494
- Acronym / sponsor ID
- DigiCare-CHD / KS2025290
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 792 participants (estimated)
- Lead sponsor
- Beijing Anzhen HospitalUniversity, hospital or other
- Study start
- Jan 2026 (estimated)
- Primary completion
- Jul 2027 (estimated)
- Study completion
- Jul 2027 (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-CHD study is an investigator-initiated, multicenter, open-label, parallel-group randomized controlled trial. It aims to evaluated the efficacy of a smartphone-based digital remote management platform compared to usual care in achieving dual goal attainment of blood pressure and LDL-cholesterol levels in patients with coronary heart disease following percutaneous coronary intervention.
Detailed description
"Coronary heart disease (CHD) remains a leading cause of global mortality. While percutaneous coronary intervention (PCI) significantly improves acute survival, patients continue to face substantial residual cardiovascular risk driven by the progression of systemic atherosclerosis. Rigorous management of blood pressure (BP) and low-density lipoprotein cholesterol (LDL-C) is imperative for secondary prevention. However, achieving simultaneous targets (BP < 130/80 mmHg and LDL-C < 1.4 mmol/L) in real-world practice is challenging due to clinical inertia and suboptimal patient adherence. Traditional outpatient follow-up is often fragmented and reactive, failing to provide the continuous monitoring required for optimal risk factor control.
The DigiCare-CHD trial serves as a prospective, multicenter, open-label randomized controlled trial designed to enroll 792 patients who have successfully undergone PCI for acute or chronic coronary syndromes. Participants will be randomized 1:1 to either the Digital Remote Management group or the Usual Care group, with a follow-up period of 12 months.
Patients in the intervention arm will utilize a digital remote management platform. This system integrates home monitoring to track BP, lipid profiles, and physical activity. Key features include AI-driven alerts for abnormal values, automated decision support for medication titration (verified by physicians), and targeted health education. The primary endpoint is the rate of dual goal attainment for BP and LDL-C at 12 months. DigiCare-CHD aims to establish a proactive, closed-loop management strategy to effectively reduce residual cardiovascular risk and improve long-term prognosis in the post-PCI population."
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 | –Patients receive standard post-PCI management, including guideline-directed medical therapy (GDMT) and routine outpatient follow-up visits at 1, 3, 6, 9, and 12 months. |
| Digital Remote Management Group | Experimental | Other: Digital Remote Management Group1-year intervention: 1. BP Management: Protocol-driven self-monitoring frequencies. The system triggers alerts for BP >130/80 mmHg and generates automated suggestions for medication titration, subject to physician approval. 2. Lipid Management: Automated reminders for laboratory testing. Optical Character Recognition (OCR) technology extracts data from lab reports. If LDL-C ≥1.4 mmol/L, the system proposes regimen intensification for physician review. 3. Exercise Management:Target of ≥6000 steps/day. Data is synchronized via wearables or smartphones. Inactivity triggers automated behavioral feedback. 4. Medication Management: Daily app-based reminders and digital "check-ins." Non-adherence triggers automated alerts followed by human intervention if persistent. 5. Symptom Monitoring: Patient-reported outcomes (e.g., chest pain/dyspnea) via the App, with automated triage for risk stratification. 6. Health Education: Push delivery of targeted secondary prevention educational materials. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age 18-75 years
- Diagnosis of Acute Coronary Syndrome (ACS) or Chronic Coronary Syndrome (CCS)
- Status post-successful percutaneous coronary intervention (PCI).
- Possession of a smartphone and ability to operate the application (independently or with caregiver assistance).
- Provision of written informed consent.
Key exclusion criteria (7 listed)
- Heart Failure: NYHA Class III-IV or LVEF < 40%.
- Severe hepatic dysfunction (ALT/AST ≥3xULN or Total Bilirubin >1.5 mg/dl)
- Severe renal dysfunction (eGFR < 30 ml/min/1.73m² or requiring dialysis)
- Uncontrolled hypothyroidism (TSH >1.5xULN or >10 mIU/L, or unstable dosage within 6 weeks)
- Life expectancy < 1 year due to non-cardiovascular comorbidities
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 Group1-year intervention 1. BP Management: Protocol-driven self-monitoring frequencies. The system triggers alerts for BP >130/80 mmHg and generates automated suggestions for medication titration, subject to physician approval. 2. Lipid Management: Automated reminders for laboratory testing. Optical Character Recognition (OCR) technology extracts data from lab reports. If LDL-C ≥1.4 mmol/L, the system proposes regimen intensification for physician review. 3. Exercise Management:Target of ≥6000 steps/day. Data is synchronized via wearables or smartphones. Inactivity triggers automated behavioral feedback. 4. Medication Management: Daily app-based reminders and digital "check-ins." Non-adherence triggers automated alerts followed by human intervention if persistent. 5. Symptom Monitoring: Patient-reported outcomes (e.g., chest pain/dyspnea) via the App, with automated triage for risk stratification. 6. Health Education: Push delivery of targeted secondary prevention educational materials. | Other | Digital Remote Management Group |
Primary outcome
Rate of Dual Goal Attainment for Blood Pressure and Lipids
Time frame: 12 months after randomization
Defined as the proportion of patients achieving both SBP < 130 mmHg and DBP < 80 mmHg and LDL-C < 1.4 mmol/L.
6 secondary outcomes
Change in Left Ventricular Ejection Fraction (LVEF)
Time frame: Baseline and 12 Months
Exercise Compliance Rate
Time frame: 12 Months
Medication Adherence
Time frame: 12 Months
Smoking Cessation Rate
Time frame: 12 Months
Quality of Life（EQ-5D-5L）
Time frame: 12 Months
Major Adverse Cardiovascular Events (MACE) Composite of all-cause death, myocardial infarction, malignant arrhythmia, or hospitalization for heart failure.
Time frame: 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 12 Jan 2026.
- Individual participant dataSharing planned: No
Related trials for Coronary Heart Disease
Not yet recruiting
GOT VOICE Feasibility With In-Person Group Singing
Elderly, Coronary Arterial Disease (CAD)
RecruitingPhase 3
Maridebart Cafraglutide in Heart Failure With Preserved or Mildly Reduced Ejection Fraction and Obesity
Heart Failure With Preserved Ejection Fraction, Heart Failure With Mildly Reduced Ejection Fraction
Active, not recruiting
ARIADNE Clinical Trial
Persistent Atrial Fibrillation
Recruiting
Evaluation of the Effects of Sauna Therapy on Congestion and Loop Diuretic Use in Patients With Heart Failure With Reduced or Moderately Reduced Ejection Fraction
Heart Failure
Recruiting
PrEcision Pacing in HFpEF: the PEP-HFpEF Trial
Heart Failure and Preserved Ejection Fraction, Heart Failure New York Heart Association Class III
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.
4 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 Coronary Heart Disease and Percutaneous Coronary Intervention, run by Beijing Anzhen Hospital at 4 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 5 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: opening soon, as of the sponsor's last update on 12 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 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 DigiCare-CHD Coordinating Center (13810720787, chshma@vip.sina.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of Dual Goal Attainment for Blood Pressure and Lipids (time frame: 12 months after randomization). 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 12 Jan 2026.