Secondary Prevention of Coronary Heart DiseaseNCT07259278
Intelligent Management Platform for Guiding Exercise Rehabilitation in Coronary Heart Disease Patients
A study testing AI-Enabled Stratified Management System and Usual post-discharge care in people with Secondary Prevention of Coronary Heart Disease, run by China National Center for Cardiovascular Diseases at 1 site in China.
Trial summary
The goal of this clinical trial is to find out if an artificial intelligence (AI)-enabled stratified management platform can help adults with coronary heart disease (CHD) better perform exercise rehabilitation and manage their health after being discharged from the hospital. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Secondary Prevention of Coronary Heart Disease
- What is being tested?
- AI-Enabled Stratified Management System and Usual post-discharge care
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteChina
- Study dates
- 1 Dec 2025to 30 Nov 2026
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- CHD patients aged over 18 years;
- Stratified as low-risk for cardiovascular events during exercise and classified as low-risk according to the GRACE risk score.
- Ability of the patient or close relatives to use smartphones and applications;
- Willingness to participate and sign the informed consent form.
Who cannot join
- Residual stenosis of >50% in the left main coronary artery, or >70% stenosis in other major epicardial vessels;
- Planned coronary revascularization within the next 3 months;
- Acute myocardial infarction within the past 1 month;
- Severe cognitive impairment;
- Severely impaired exercise capacity.
- Advanced-stage malignancy;
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- Life expectancy less than 3 months;
- Severe multi-organ failure;
- Other conditions deemed unsuitable for home-based exercise rehabilitation following assessment by a specialist rehabilitation physician.
- Refusal to provide written informed consent.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Fuwai Hospital, Chinese Academy of Medical Sciences/National Center for Cardiovascular Diseases
Beijing, Beijing Municipality, 100037
Prof. Gao, MD, PhD, 010-88322413, sophie_gao@sina.com
About this study
Official title: Artificial Intelligence-enhanced Stratified Management Platform Guiding Home-based Exercise Rehabilitation for Coronary Heart Disease Patients: a Randomized Control Trial
The goal of this clinical trial is to find out if an artificial intelligence (AI)-enabled stratified management platform can help adults with coronary heart disease (CHD) better perform exercise rehabilitation and manage their health after being discharged from the hospital. The main questions it aims to answer are:
- Does using the AI platform lead to a greater improvement in exercise capacity (measured by peak oxygen consumption, VO2peak) after 3 months?
- Does the platform help increase daily physical activity, improve exercise adherence and motivation, and better control modifiable cardiovascular risk factors?
- Is guiding home-based exercise with this platform safe for low-risk CHD patients?
Read more
Researchers will compare the AI Management Group (using the platform and a sports wristband) to the Routine Management Group (receiving usual care without the platform) to see if the AI group shows more significant improvements in fitness and health metrics.
Participants will:
- Be randomly assigned to either use the AI platform or receive usual post-discharge care.
- Receive a personalized exercise prescription from a doctor before going home.
- If in the AI group: Use the smartphone app and wearable device to track health data for comprehensive post-discharge management, and receive reminders and immediate safety alerts.
- Attend a follow-up visit at 3 months for check-ups and tests, including an exercise test and health assessments.
The study hopes to show that this intelligent management platform is an effective and safe tool to help people with CHD recover at home, stay active, and reduce future heart risks.
- Being tested
- AI-Enabled Stratified Management System, Usual post-discharge care
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AI-Enabled Stratified Management SystemCombination product
Following discharge, participants in the AI-stratified management group will use an intelligent platform (smartphone app + wearable divice) for home-based exercise rehabilitation and comprehensive post-discharge care. Key features include: 1) Safety Monitoring \& Alerts: Real-time tracking of heart rate and other parameters via wristband triggers immediate safety warnings during exercise; 2) Holistic Risk Management: Integrated support for lifestyle modification, medication adherence, and control of cardiovascular risk factors; 3) Structured Engagement: Multi-channel reminders (messages, alarms, voice calls) for medications, exercise, and follow-ups to sustain adherence.
Usual post-discharge careCombination product
Usual discharge protocol comprising verbal and printed discharge instructions addressing medication schedules, follow-up timelines, and lifestyle optimization strategies as well as a personalized exercise prescription.
| Study group | Role | What they receive |
|---|---|---|
| AI-Enabled Stratified Management Group | Experimental | Participants in the intervention group will receive comprehensive post-hospital rehabilitation management through an AI-based stratified management platform, utilizing a smartphone app and wearable device to track health data, deliver reminders and immediate safety alerts. Receives: Combination Product: AI-Enabled Stratified Management System; Combination Product: Usual post-discharge care |
| Standard Post-Discharge Care Group | Active comparator | Participants in the control group will receive usual discharge protocol and personalized exercise prescription and goals from a specialist. Receives: Combination Product: Usual post-discharge care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Peak oxygen consumption (VO2peak)
Peak oxygen consumption (VO2peak, mL∙kg-¹min-¹)
Measured: From enrollment to the end of treatment at 3 months.
Secondary outcomes (16)
Change in 6-minute walk distance
6-minute walk distance (m)
Measured: From enrollment to the end of treatment at 3 months
Change in physical activity level (MET-min/week)
Physical activity level (MET-min/week), estimated using the International Physical Activity Questionnaire-Short Form (IPAQ-SF). It consists of 7 questions with a recall period defined as 'last week'. The questions of the scale ask whether the participant walks for at least 10 minutes on any given day or does moderate or vigorous activities, and how much time/day the individual spends on each of these activities or sit.
Measured: From enrollment to the end of treatment at 3 months
Change in average daily step count
Average daily step count (steps per day)
Measured: From enrollment to the end of treatment at 3 months
Exercise adherence
In the self-reported exercise diary, the participant will note the number of exercises done at home. The percentage adherence to the prescribed exercise regimen was calculated by dividing the number of exercises performed by the number of exercises prescribed and multiplying by 100.
Measured: From enrollment to the end of treatment at 3 months.
Composite endpoints
A composite endpoint including all-cause mortality, cardiac arrest, non-fatal myocardial infarction, and symptom-driven unplanned rehospitalization occurring during exercise. Safety endpoint during rehabilitation.
Measured: From enrollment to the end of treatment at 3 months
Systolic blood pressure (mmHg)
Systolic blood pressure. Unit of Measure: mmHg.
Measured: From enrollment to the end of treatment at 3 months
Diastolic blood pressure (mmHg)
Diastolic blood pressure. Unit of Measure: mmHg.
Measured: From enrollment to the end of treatment at 3 months
Glycated hemoglobin (HbA1c, %)
Glycated hemoglobin. Unit of Measure: %.
Measured: From enrollment to the end of treatment at 3 months
Low-density lipoprotein cholesterol (LDL-C, mmol/L)
Unit of Measure: mmol/L
Measured: From enrollment to the end of treatment at 3 months
Body mass index (BMI, kg/m^2)
Measured: From enrollment to the end of treatment at 3 months
Unplanned rehospitalization due to cardiovascular causes
Measured: From enrollment to the end of treatment at 3 months
Major Adverse Cardiovascular Events (MACE)
Major Adverse Cardiovascular Events (MACE), defined as cardiovascular death, non-fatal myocardial infarction, and non-fatal stroke.
Measured: From enrollment to the end of treatment at 3 months
Anxiety level by Generalized Anxiety Disorder-7 scale score
Anxiety level, assessed using the Generalized Anxiety Disorder-7 (GAD-7) questionnaire. Patients will be evaluated at the beginning and at the endpoint of the study with the self-administered GAD-7 scale. The GAD-7 scale score ranges from 0 to 21 points. A score between 5 and 9 points characterizes mild GAD. Between 10 and 14, moderate GAD and between 15 and 21, severe GAD.
Measured: From enrollment to the end of treatment at 3 months
Depression level by Patient Health Questionnaire-9 (PHQ-9)
Depression level, assessed using the Patient Health Questionnaire-9 (PHQ-9). The GAD-7 scale score ranges from 0 to 27 points. A score between 5 and 9 points characterizes mild depression. Between 10 and 14, moderate depression; between 15 and 19, moderate-severe depression; and between 20 and 27, severe depression.
Measured: From enrollment to the end of treatment at 3 months
Sleep quality, assessed using the Pittsburgh Sleep Quality Index (PSQI)
Sleep quality, assessed using the Pittsburgh Sleep Quality Index (PSQI). The total score ranges from 0 to 21 with a higher score indicating poor quality of sleep (worse). The higher the score, the worse the sleep quality. A cut-off score of >5 indicates poor sleep quality.
Measured: From enrollment to the end of treatment at 3 months
Quality of life by the EuroQol-5 Dimensions-5 Levels (EQ-5D-5L) questionnaire
Quality of life, assessed using the EuroQol-5 Dimensions-5 Levels (EQ-5D-5L) questionnaire. This questionnaire asks 5 multiple-choice questions about mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems and extreme problems. The patient is asked to indicate his/her health state by ticking the box next to the most appropriate statement in each of the five dimensions. EQ-5D-5L index scores range from 0 to 100, where 100 is the best possible health state.
Measured: From enrollment to the end of treatment at 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Dec 2025
- Study start1 Dec 2025 (estimated)
- Primary completion30 Nov 2026 (estimated)
- Study completion30 Nov 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Secondary Prevention of Coronary Heart DiseaseStudies of the same condition, open and under way.
- More trials run by China National Center for Cardiovascular DiseasesThe 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Sponsor type
- Other government
- Collaborators
- Chinese Academy of Medical Sciences
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07259278
- Sponsor's protocol ID
- 2024-I2M-C&T-B-040
- Status last verified
- Nov 2025
- First submitted
- 14 Nov 2025
- Last updated
- 2 Dec 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Individual participant data (IPD) that underlie the results reported in publications will be shared, including all collected de-identified IPD.
Study at a glance
From the registry record, last updated by the sponsor on 2 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Artificial Intelligence-enhanced Stratified Management Platform Guiding Home-based Exercise Rehabilitation for Coronary Heart Disease Patients: a Randomized Control Trial
- ClinicalTrials.gov ID
- NCT07259278
- Acronym / sponsor ID
- 2024-I2M-C&T-B-040
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- China National Center for Cardiovascular DiseasesOther government
- Collaborators
- Chinese Academy of Medical Sciences
- Study start
- 1 Dec 2025 (estimated)
- Primary completion
- 30 Nov 2026 (estimated)
- Study completion
- 30 Nov 2026 (estimated)
- First posted
- 2 Dec 2025 (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 goal of this clinical trial is to find out if an artificial intelligence (AI)-enabled stratified management platform can help adults with coronary heart disease (CHD) better perform exercise rehabilitation and manage their health after being discharged from the hospital. The main questions it aims to answer are:
- Does using the AI platform lead to a greater improvement in exercise capacity (measured by peak oxygen consumption, VO2peak) after 3 months?
- Does the platform help increase daily physical activity, improve exercise adherence and motivation, and better control modifiable cardiovascular risk factors?
- Is guiding home-based exercise with this platform safe for low-risk CHD patients?
Researchers will compare the AI Management Group (using the platform and a sports wristband) to the Routine Management Group (receiving usual care without the platform) to see if the AI group shows more significant improvements in fitness and health metrics.
Participants will:
- Be randomly assigned to either use the AI platform or receive usual post-discharge care.
- Receive a personalized exercise prescription from a doctor before going home.
- If in the AI group: Use the smartphone app and wearable device to track health data for comprehensive post-discharge management, and receive reminders and immediate safety alerts.
- Attend a follow-up visit at 3 months for check-ups and tests, including an exercise test and health assessments.
The study hopes to show that this intelligent management platform is an effective and safe tool to help people with CHD recover at home, stay active, and reduce future heart risks.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| AI-Enabled Stratified Management Group | Experimental | Combination Product: AI-Enabled Stratified Management System, Combination Product: Usual post-discharge careParticipants in the intervention group will receive comprehensive post-hospital rehabilitation management through an AI-based stratified management platform, utilizing a smartphone app and wearable device to track health data, deliver reminders and immediate safety alerts. |
| Standard Post-Discharge Care Group | Active comparator | Combination Product: Usual post-discharge careParticipants in the control group will receive usual discharge protocol and personalized exercise prescription and goals from a specialist. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- CHD patients aged over 18 years;
- Stratified as low-risk for cardiovascular events during exercise and classified as low-risk according to the GRACE risk score.
- Ability of the patient or close relatives to use smartphones and applications;
- Willingness to participate and sign the informed consent form.
Key exclusion criteria (10 listed)
- Residual stenosis of >50% in the left main coronary artery, or >70% stenosis in other major epicardial vessels;
- Planned coronary revascularization within the next 3 months;
- Acute myocardial infarction within the past 1 month;
- Severe cognitive impairment;
- Severely impaired exercise capacity.
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 |
|---|---|---|
| AI-Enabled Stratified Management SystemFollowing discharge, participants in the AI-stratified management group will use an intelligent platform (smartphone app + wearable divice) for home-based exercise rehabilitation and comprehensive post-discharge care. Key features include: 1) Safety Monitoring \& Alerts: Real-time tracking of heart rate and other parameters via wristband triggers immediate safety warnings during exercise; 2) Holistic Risk Management: Integrated support for lifestyle modification, medication adherence, and control of cardiovascular risk factors; 3) Structured Engagement: Multi-channel reminders (messages, alarms, voice calls) for medications, exercise, and follow-ups to sustain adherence. | Combination product | AI-Enabled Stratified Management Group |
| Usual post-discharge careUsual discharge protocol comprising verbal and printed discharge instructions addressing medication schedules, follow-up timelines, and lifestyle optimization strategies as well as a personalized exercise prescription. | Combination product | AI-Enabled Stratified Management Group, Standard Post-Discharge Care Group |
Primary outcome
Peak oxygen consumption (VO2peak)
Time frame: From enrollment to the end of treatment at 3 months.
Peak oxygen consumption (VO2peak, mL∙kg-¹min-¹)
16 secondary outcomes
Change in 6-minute walk distance
Time frame: From enrollment to the end of treatment at 3 months
Change in physical activity level (MET-min/week)
Time frame: From enrollment to the end of treatment at 3 months
Change in average daily step count
Time frame: From enrollment to the end of treatment at 3 months
Exercise adherence
Time frame: From enrollment to the end of treatment at 3 months.
Composite endpoints
Time frame: From enrollment to the end of treatment at 3 months
Systolic blood pressure (mmHg)
Time frame: From enrollment to the end of treatment at 3 months
Diastolic blood pressure (mmHg)
Time frame: From enrollment to the end of treatment at 3 months
Glycated hemoglobin (HbA1c, %)
Time frame: From enrollment to the end of treatment at 3 months
Low-density lipoprotein cholesterol (LDL-C, mmol/L)
Time frame: From enrollment to the end of treatment at 3 months
Body mass index (BMI, kg/m^2)
Time frame: From enrollment to the end of treatment at 3 months
Unplanned rehospitalization due to cardiovascular causes
Time frame: From enrollment to the end of treatment at 3 months
Major Adverse Cardiovascular Events (MACE)
Time frame: From enrollment to the end of treatment at 3 months
Anxiety level by Generalized Anxiety Disorder-7 scale score
Time frame: From enrollment to the end of treatment at 3 months
Depression level by Patient Health Questionnaire-9 (PHQ-9)
Time frame: From enrollment to the end of treatment at 3 months
Sleep quality, assessed using the Pittsburgh Sleep Quality Index (PSQI)
Time frame: From enrollment to the end of treatment at 3 months
Quality of life by the EuroQol-5 Dimensions-5 Levels (EQ-5D-5L) questionnaire
Time frame: From enrollment to the end of treatment at 3 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 2 Dec 2025.
- Individual participant dataSharing planned: Yes. Individual participant data (IPD) that underlie the results reported in publications will be shared, including all collected de-identified IPD.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing AI-Enabled Stratified Management System and Usual post-discharge care in people with Secondary Prevention of Coronary Heart Disease, run by China National Center for Cardiovascular Diseases 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 4 inclusion and 10 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 2 Dec 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?
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 Prof. Gao, MD, PhD (010-88322413, sophie_gao@sina.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Peak oxygen consumption (VO2peak) (time frame: From enrollment to the end of treatment at 3 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 2 Dec 2025.