Coronary Artery DiseaseNCT06542575
Efficacy of the Integration of Digital Therapeutics and Home-based Cardiac Rehabilitation in High-Risk Post-PCI Patients
A study testing DTx-guided HBCR in people with Coronary Artery Disease and Myocardial Infarction, run by West China Hospital at 1 site in China.
Trial summary
The DTx-HBCR trial will randomize 366 high-risk patients who undergo PCI at the West China Hospital of Sichuan University to either the 6-month DTx-guided HBCR group (intervention group) or the 6-months usual care group (control group) in a parallel-arm randomized controlled trial. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Coronary Artery Disease, Myocardial Infarction
- What is being tested?
- DTx-guided HBCR
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 366 participants
- Where
- 1 siteChina
- Study dates
- 4 Dec 2024to May 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- To be eligible to participate in this study, a participant must meet all of the following criteria:
- Women or men, the ages of 18 and 75 years.
- Have sufficient reading and writing language skills in Chinese.
- Be willing to participate the study and sign informed consent.
- Patients must have at least one clinical feature and one angiographic feature:
- Clinical features: age ≥ 65 years, female sex, troponin positive acute coronary syndrome, established vascular disease (prior myocardial infarction, coronary revascularization or peripheral arterial disease) , diabetes mellitus requiring medication and chronic kidney disease (estimated glomerular filtration rate < 60 ml/min/1.73 m2 or creatinine clearance < 60 cc/min) .
- Angiographic features: multivessel coronary artery disease, total stent length > 30 mm, thrombotic target lesion, bifurcation lesion requiring two stents, obstructive left main or proximal left anterior descending lesion and calcified target lesion requiring atherectomy.
Who cannot join
- A potential participant who meets any of the following criteria will be excluded from participation in this study:
- Contraindications to exercise rehabilitation (e.g., untreated ventricular tachycardia, severe heart failure (New York Heart Association class III or IV heart failure, or ejection fraction < 40%), uncontrolled hypertension or hypotension, active hemorrhage, severe liver failure, significant exercise limitations).
- Vision, hearing, cognition-related or mental impairment leading to inability to cooperate.
- Patients with established planned Phase II PCI.
- Having pre-existing comorbid disease with a life expectancy of < 1 year.
- Poor compliance and unable to complete the expected follow-up.
- Unable to access WeChat via a smartphone after training.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Efficacy of the Integration of Digital Therapeutics and Home-based Cardiac Rehabilitation in High-Risk Post-PCI Patients on Cardiovascular Health
The DTx-HBCR trial will randomize 366 high-risk patients who undergo PCI at the West China Hospital of Sichuan University to either the 6-month DTx-guided HBCR group (intervention group) or the 6-months usual care group (control group) in a parallel-arm randomized controlled trial. The primary outcome is the difference between the intervention group and control group in walk distance on the 6-minute walk test (i.e., functional capacity) at 6 months post randomization. The key secondary outcomes include improvements in cardiovascular risk factor control, quality of life, psychological status, physical activity, major adverse cardiovascular events, and medication adherence. This study aims to evaluate the DTx-guided HBCR, a software-driven, multidisciplinary health intervention as an alternative to traditional in-center CR in patients with high-risk patients following percutaneous coronary intervention (PCI) compared with usual care alone.
- Conditions
- Coronary Artery Disease, Myocardial Infarction
- Being tested
- DTx-guided HBCR
- Medical subject headings
- Coronary Artery Disease, Myocardial Infarction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DTx-guided HBCROther
The Huaxiaoxin WeChat mini program incorporating the core components of guidelines are divided into two main sections. Section 1 comprises interventions such as exercise training, educational programmes and cardiovascular risk factor management. Section 2 provides a secure platform for individualized feedback, just-in-time two-way communication, remote data transmission, and data repository, allowing patients and healthcare providers to access all relevant files anytime and anywhere throughout the 12-month study period.
| Study group | Role | What they receive |
|---|---|---|
| DTx-guided HBCR group | Experimental | Not described Receives: Other: DTx-guided HBCR |
| Usual care group | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in 6-minute walk distance (i.e., functional capacity) at 6 months post randomization
Change in distance participants walked (i.e., functional capacity) between the intervention and usual care groups, as measured by the 6MWT at 6 months postrandomization.
Measured: At 6 months post randomization
Secondary outcomes (6)
Change in functional capacity at 3 months postrandomization
Change in distance participants walked (i.e., functional capacity) between the intervention and usual care groups, as measured by the 6MWT at 3 months postrandomization.
Measured: At 3 months postrandomization
Change in conventional CVD risk factors at 3, 6 months post randomization
Changes in conventional CVD risk factors, such as lipid profile, glycosylated hemoglobin, BMI, BP, and smoking habits.
Measured: At 3, 6 months post randomization
Change in quality of life at 3, 6 months post randomization
Quality of life as assessed by the Seattle Angina Questionnaire41 and the EuroQol 5-Dimensions Questionnaire.
Measured: At 3, 6 months post randomization
Change in psychological status at 3, 6 months post randomization
Depression scores, as assessed by the 9-item Patient Health Questionnaire; anxiety scores, as assessed by the 7-item Generalized Anxiety Disorder questionnaire.
Measured: At 3, 6 months post randomization
Change in physical activity levels at 3, 6 months post randomization
Qhysical activity levels as assessed by the International Physical Activity Questionnaire.
Measured: At 3, 6 months post randomization
Change in medication adherence at 3, 6 months post randomization
Medication adherence as assessed by the 8-item Morisky Medication Adherence Scale.
Measured: At 3, 6 months post randomization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Aug 2024
- Study start4 Dec 2024
- Primary completionNov 2025 (estimated)
- Study completionMay 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Coronary Artery DiseaseStudies of the same condition, open and under way.
- More trials run by West China HospitalThe sponsor's other registered studies.
- 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 366 participants (estimated)
Sponsor and investigators
- Lead sponsor
- West China Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yong He, Sichuan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06542575
- Sponsor's protocol ID
- WestChinaH-CVD-006
- Status last verified
- Aug 2024
- First submitted
- 4 Aug 2024
- Last updated
- 14 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Publications
Ma S, Chen Z, Zhang J, Liu J, Xu L, Huang B, Zhou M, Wang H, Chen Y, Wang M, Li C, He Y; DTx-HBCR trial investigators. Evaluation of the efficacy of integrating digital therapeutics with home-based cardiac rehabilitation on cardiovascular health in high-risk post-PCI patients (DTx-HBCR): Study protocol for a randomized controlled trial. Digit Health. 2025 Jul 25;11:20552076251360885. doi: 10.1177/20552076251360885. eCollection 2025 Jan-Dec.
PubMed 40735550
Study at a glance
From the registry record, last updated by the sponsor on 14 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of the Integration of Digital Therapeutics and Home-based Cardiac Rehabilitation in High-Risk Post-PCI Patients on Cardiovascular Health
- ClinicalTrials.gov ID
- NCT06542575
- Acronym / sponsor ID
- WestChinaH-CVD-006
- Conditions
- Coronary Artery Disease, Myocardial Infarction
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 366 participants (estimated)
- Lead sponsor
- West China HospitalUniversity, hospital or other
- Study start
- 4 Dec 2024 (actual)
- Primary completion
- Nov 2025 (estimated)
- Study completion
- May 2026 (estimated)
- First posted
- 7 Aug 2024 (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 DTx-HBCR trial will randomize 366 high-risk patients who undergo PCI at the West China Hospital of Sichuan University to either the 6-month DTx-guided HBCR group (intervention group) or the 6-months usual care group (control group) in a parallel-arm randomized controlled trial. The primary outcome is the difference between the intervention group and control group in walk distance on the 6-minute walk test (i.e., functional capacity) at 6 months post randomization. The key secondary outcomes include improvements in cardiovascular risk factor control, quality of life, psychological status, physical activity, major adverse cardiovascular events, and medication adherence. This study aims to evaluate the DTx-guided HBCR, a software-driven, multidisciplinary health intervention as an alternative to traditional in-center CR in patients with high-risk patients following percutaneous coronary intervention (PCI) compared with usual care alone.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| DTx-guided HBCR group | Experimental | Other: DTx-guided HBCR |
| Usual care group | No intervention | – |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- To be eligible to participate in this study, a participant must meet all of the following criteria:
- Clinical features: age ≥ 65 years, female sex, troponin positive acute coronary syndrome, established vascular disease (prior myocardial infarction, coronary revascularization or peripheral arterial disease) , diabetes mellitus requiring medication and chronic kidney disease (estimated glomerular filtration rate < 60 ml/min/1.73 m2 or creatinine clearance < 60 cc/min) .
- Angiographic features: multivessel coronary artery disease, total stent length > 30 mm, thrombotic target lesion, bifurcation lesion requiring two stents, obstructive left main or proximal left anterior descending lesion and calcified target lesion requiring atherectomy.
Key exclusion criteria (7 listed)
- A potential participant who meets any of the following criteria will be excluded from participation in this study:
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 |
|---|---|---|
| DTx-guided HBCRThe Huaxiaoxin WeChat mini program incorporating the core components of guidelines are divided into two main sections. Section 1 comprises interventions such as exercise training, educational programmes and cardiovascular risk factor management. Section 2 provides a secure platform for individualized feedback, just-in-time two-way communication, remote data transmission, and data repository, allowing patients and healthcare providers to access all relevant files anytime and anywhere throughout the 12-month study period. | Other | DTx-guided HBCR group |
Primary outcome
Change in 6-minute walk distance (i.e., functional capacity) at 6 months post randomization
Time frame: At 6 months post randomization
Change in distance participants walked (i.e., functional capacity) between the intervention and usual care groups, as measured by the 6MWT at 6 months postrandomization.
6 secondary outcomes
Change in functional capacity at 3 months postrandomization
Time frame: At 3 months postrandomization
Change in conventional CVD risk factors at 3, 6 months post randomization
Time frame: At 3, 6 months post randomization
Change in quality of life at 3, 6 months post randomization
Time frame: At 3, 6 months post randomization
Change in psychological status at 3, 6 months post randomization
Time frame: At 3, 6 months post randomization
Change in physical activity levels at 3, 6 months post randomization
Time frame: At 3, 6 months post randomization
Change in medication adherence at 3, 6 months post randomization
Time frame: At 3, 6 months post randomization
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jan 2025.
- Derived from this study: PubMed 40735550Ma S, Chen Z, Zhang J, Liu J, Xu L, Huang B, Zhou M, Wang H, Chen Y, Wang M, Li C, He Y; DTx-HBCR trial investigators. Evaluation of the efficacy of integrating digital therapeutics with home-based cardiac rehabilitation on cardiovascular health in high-risk post-PCI patients (DTx-HBCR): Study protocol for a randomized controlled trial. Digit Health. 2025 Jul 25;11:20552076251360885. doi: 10.1177/20552076251360885. eCollection 2025 Jan-Dec.
- Individual participant dataSharing planned: Yes
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing DTx-guided HBCR in people with Coronary Artery Disease and Myocardial Infarction, run by West China Hospital at 1 site 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 7 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: status not confirmed, as of the sponsor's last update on 14 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in 6-minute walk distance (i.e., functional capacity) at 6 months post randomization (time frame: At 6 months post randomization). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06542575, which also lists 1 linked publication.
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 14 Jan 2025.