Premature Coronary Heart DiseaseSMART-CHDNCT07031531
Effectiveness of an AI-Enabled Stratified Management System for Premature Coronary Artery Disease
A study testing AI-Enabled Stratified Management System and Usual Post-Discharge Care in people with Premature Coronary Heart Disease, run by China National Center for Cardiovascular Diseases at 16 sites in China.
Trial summary
The goal of this clinical trial is to learn if an AI-enabled stratified management system (SMART-CHD) can improve post-discharge outcomes in adults aged 18-45 with premature coronary artery disease. The main questions it aims to answer are: 1. Read more about this study
- Who is it for?
- Ages 18 to 45 years
- Conditions the study is for
- Premature 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
- 4,900 participants
- Where
- 16 sitesChina
- Study dates
- 8 Aug 2025to 31 Aug 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 18 to 45 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Patients with coronary heart disease aged 18-45 years;
- The patient or a close family member is capable of using a smartphone and mobile application (App);
- Willing to participate in the study and able to provide written informed consent.
Who cannot join
- Severe cognitive impairment;
- Advanced-stage malignancy;
- Life expectancy less than 12 months;
- Severe multi-organ failure;
- Refusal to provide written informed consent.
Trial locations and contacts
16 sites in 1 country. Contact the study team or a site near you to ask about taking part.
16 sites in 1 country
China16 sites, 16 recruiting
- Recruiting
Fuwai Hospital, Chinese Academy of Medical Sciences/National Center for Cardiovascular Diseases
Beijing, Beijing Municipality, 100037
Gao Prof. Gao, MD, PhD, +86 8832 2413, sophie_gao@sina.com
- Not yet recruiting
The Second Affiliated Hospital, School of Medicine, Zhejiang University
Hangzhou, Zhejiang, 310009
Bingchen Liu, MD, 0571-87783777, liubingchen111@zju.edu.cn
- Not yet recruiting
The First Affiliated Hospital of University of Science and Technology of China
Hefei, Anhui, 230001
Ke Meng, 19995377625, 19995377625@163.com
- Not yet recruiting
The First Affiliated Hospital of Henan University of Science and Technology
Luoyang, Henan, 471003
Mengjuan Xu, 15903076908, zhijuanli66@sina.com
- Not yet recruiting
The Affiliated Hospital of Southwest Medical University
Luzhou, Sichuan, 400042
Ling Wu, MD, 0830-3165101, wulingzt@163.com
- Not yet recruiting
The First Affiliated Hospital of Nanjing Medical University
Nanjing, Jiangsu, 210029
Jiabao Liu, MD, 025-68303127, jiabaoliu@njmu.edu.cn
- Not yet recruiting
Fuwai Hospital Chinese Academy of Medical Sciences, Shenzhen
Shenzhen, Guangdong, 518057
Fenghuan Hu, MD, 0755-25509566, hufenghuanvip@163.com
- Not yet recruiting
The First Hospital of Hebei Medical University
Shijiazhuang, Hebei, 050000
Fangfang Ma, 13932108925, fad@hebmu.edu.cn
- Not yet recruiting
The Second Hospital Of Hebe Medical University
Shijiazhuang, Hebei, 050000
Xinshun Gu, 0311-66636037, pub@hb2h.com
- Not yet recruiting
Shanxi Cardiovascular Disease Hospital
Taiyuan, Shanxi, 030024
Jingyi Liu, 18235123471, 18235123471@163.com
- Not yet recruiting
The Second Affiliated Hospital of Xi'an Jiaotong University
Xi'an, Shaanxi, 710004
Jie Liu, 029-87679000, eyshce@126.com
- Not yet recruiting
The First Affiliated Hospital of Xi'an Jiaotong University
Xi'an, Shaanxi, 710061
Huan Wu, MD, 029-85323211, 1279952786@qq.com
- Not yet recruiting
Northern Jiangsu People's Hospital
Yangzhou, Jiangsu, 225001
Jing Yang, 18512178336, nyxb1980@163.com
- Not yet recruiting
Henan Provincial Chest Hospital
Zhengzhou, Henan, 450000
Zhe Peng, 15538128220, 15538128220@qq.com
- Not yet recruiting
Zhengzhou University Affiliated Zhengzhou Central Hospital
Zhengzhou, Henan, 450000
Xiaojie Yang, 18631423366, 18631423366@163.com
- Not yet recruiting
Zhengzhou University Fuwai Central China Cardiovascular Hospital
Zhengzhou, Henan, 450000
You Zhang, 13932108925, gaocy6802@163.com
About this study
Official title: Effectiveness of an AI-Enabled Stratified Management System for Premature Coronary Artery Disease (SMART-CHD): A Prospective, Multicenter, Open-Label, Randomized Controlled Trial
The goal of this clinical trial is to learn if an AI-enabled stratified management system (SMART-CHD) can improve post-discharge outcomes in adults aged 18-45 with premature coronary artery disease. The main questions it aims to answer are:
- Does SMART-CHD reduce the combined rate of all-cause death, myocardial infarction, stroke and rehospitalization within 12 months?
- Does SMART-CHD achieve better control of modifiable risk factors compared with usual care?
Read more
Researchers will compare SMART-CHD to standard discharge management (verbal and printed instructions on medications, follow-up timelines and lifestyle advice) to see if the AI-driven platform leads to fewer adverse events and improved risk-factor profiles.
Participants will:
- Install and use the SMART-CHD mobile app after a 10-minute structured orientation session with supervised simulations.
- Complete regular in-app surveys on lifestyle behaviors, laboratory/imaging results and clinical events (with OCR-powered LLM assistance).
- Wear paired sensors for continuous monitoring of blood pressure, heart rate and other physiologic metrics.
- Receive automated EHR data harvesting, AI-driven voice-call reminders, and real-time CRC support via a dedicated WeChat group.
- Follow personalized, guideline-based risk-factor recommendations (diet, exercise, sleep, weight, smoking, alcohol, hypertension, dyslipidemia, diabetes).
- Conditions
- Premature Coronary Heart Disease
- Being tested
- AI-Enabled Stratified Management System, Usual Post-Discharge Care
- Keywords
- Premature coronary heart disease, secondary prevention, long-term management, mobile health, artificial intelligence
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
After discharge, participants install SMART-CHD, sync their EHR data, and complete a 10-minute orientation. They then use the app's OCR-assisted surveys to report lifestyle, lab, and event data, while paired wearables stream continuous vitals. AI voice calls and a CRC-managed WeChat group deliver reminders and support. The app's embedded predictive models stratify them into risk tiers and generate tier-specific follow-up schedules. Personalized lifestyle modification guidance, dietary plans, and medication adjustment recommendations are generated by the platform's module. Automated alerts and teleconsultation options are triggered upon detection of high-risk signs or abnormal results, ensuring timely clinical intervention and enhanced secondary prevention.
Usual Post-Discharge CareCombination product
Usual discharge protocol comprising verbal and printed discharge instructions addressing medication schedules, follow-up timelines, and lifestyle optimization strategies.
| Study group | Role | What they receive |
|---|---|---|
| AI-Enabled Stratified Management Group | Experimental | Participants in the intervention group will use SMART-CHD alongside usual post-discharge care. Receives: Combination Product: AI-Enabled Stratified Management System; Combination Product: Usual Post-Discharge Care |
| Usual Post-Discharge Care Group | Active comparator | Participants in the control group will receive usual discharge protocol comprising verbal and printed discharge instructions addressing medication schedules, follow-up timelines, and lifestyle optimization strategies. Receives: Combination Product: Usual Post-Discharge Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cardiovascular Composite Endpoint Events
A composite of all-cause death, myocardial infarction, stroke, and unplanned cardiovascular-related rehospitalization.
Measured: Assessed at 12 months post-discharge
Secondary outcomes (8)
Individual components of cardiac events
All-cause death, myocardial infarction, stroke, and unplanned cardiovascular-related rehospitalization
Measured: Assessed at 12 months post-discharge
LDL-C level
Low-density lipoprotein cholesterol level. Unit of Measure: mmol/L.
Measured: Assessed at 12 months post-discharge
LDL-C Goal Attainment
Achieving LDL-C < 1.8 mmol/L.
Measured: Assessed at 12 months post-discharge
Blood pressure level
Systolic blood pressure and Diastolic blood pressure. Unit of Measure: mmHg.
Measured: Assessed at 12 months post-discharge
Blood pressure goal attainment
Achieving target BP <130/80 mmHg.
Measured: Assessed at 12 months post-discharge
Hemoglobin A1c level
Glycated hemoglobin (HbA1c). Unit of Measure: Percentage (%).
Measured: Assessed at 12 months post-discharge
Smoking
Self-reported current smoking status. Unit of Measure: Number and percentage of current smokers
Measured: Assessed at 12 months post-discharge
Medication adherence to antiplatelet agents and statins
Adherence is defined as self-reported use of the medication for more than 80% of the time during the past month
Measured: Assessed at 12 months post-discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jun 2025
- Study start8 Aug 2025
- Primary completion31 Aug 2028 (estimated)
- Study completion31 Aug 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Premature 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 4,900 participants (estimated)
Sponsor and investigators
- Sponsor type
- Other government
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07031531
- Sponsor's protocol ID
- 2023ZD0504005
- Acronym
- SMART-CHD
- Status last verified
- Aug 2026
- First submitted
- 18 May 2025
- Last updated
- 18 Aug 2026
- 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 18 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of an AI-Enabled Stratified Management System for Premature Coronary Artery Disease (SMART-CHD): A Prospective, Multicenter, Open-Label, Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07031531
- Acronym / sponsor ID
- SMART-CHD / 2023ZD0504005
- Conditions
- Premature Coronary Heart Disease
- Keywords
- Premature coronary heart disease, secondary prevention, long-term management, mobile health, artificial intelligence
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 4,900 participants (estimated)
- Lead sponsor
- China National Center for Cardiovascular DiseasesOther government
- Study start
- 8 Aug 2025 (actual)
- Primary completion
- 31 Aug 2028 (estimated)
- Study completion
- 31 Aug 2028 (estimated)
- First posted
- 22 Jun 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 learn if an AI-enabled stratified management system (SMART-CHD) can improve post-discharge outcomes in adults aged 18-45 with premature coronary artery disease. The main questions it aims to answer are:
- Does SMART-CHD reduce the combined rate of all-cause death, myocardial infarction, stroke and rehospitalization within 12 months?
- Does SMART-CHD achieve better control of modifiable risk factors compared with usual care?
Researchers will compare SMART-CHD to standard discharge management (verbal and printed instructions on medications, follow-up timelines and lifestyle advice) to see if the AI-driven platform leads to fewer adverse events and improved risk-factor profiles.
Participants will:
- Install and use the SMART-CHD mobile app after a 10-minute structured orientation session with supervised simulations.
- Complete regular in-app surveys on lifestyle behaviors, laboratory/imaging results and clinical events (with OCR-powered LLM assistance).
- Wear paired sensors for continuous monitoring of blood pressure, heart rate and other physiologic metrics.
- Receive automated EHR data harvesting, AI-driven voice-call reminders, and real-time CRC support via a dedicated WeChat group.
- Follow personalized, guideline-based risk-factor recommendations (diet, exercise, sleep, weight, smoking, alcohol, hypertension, dyslipidemia, diabetes).
Study design
- Primary purpose
- Prevention
- 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 use SMART-CHD alongside usual post-discharge care. |
| Usual Post-Discharge Care Group | Active comparator | Combination Product: Usual Post-Discharge CareParticipants in the control group will receive usual discharge protocol comprising verbal and printed discharge instructions addressing medication schedules, follow-up timelines, and lifestyle optimization strategies. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Patients with coronary heart disease aged 18-45 years;
- The patient or a close family member is capable of using a smartphone and mobile application (App);
- Willing to participate in the study and able to provide written informed consent.
Key exclusion criteria (5 listed)
- Severe cognitive impairment;
- Advanced-stage malignancy;
- Life expectancy less than 12 months;
- Severe multi-organ failure;
- Refusal to provide written informed consent.
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 SystemAfter discharge, participants install SMART-CHD, sync their EHR data, and complete a 10-minute orientation. They then use the app's OCR-assisted surveys to report lifestyle, lab, and event data, while paired wearables stream continuous vitals. AI voice calls and a CRC-managed WeChat group deliver reminders and support. The app's embedded predictive models stratify them into risk tiers and generate tier-specific follow-up schedules. Personalized lifestyle modification guidance, dietary plans, and medication adjustment recommendations are generated by the platform's module. Automated alerts and teleconsultation options are triggered upon detection of high-risk signs or abnormal results, ensuring timely clinical intervention and enhanced secondary prevention. | 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. | Combination product | AI-Enabled Stratified Management Group, Usual Post-Discharge Care Group |
Primary outcome
Cardiovascular Composite Endpoint Events
Time frame: Assessed at 12 months post-discharge
A composite of all-cause death, myocardial infarction, stroke, and unplanned cardiovascular-related rehospitalization.
8 secondary outcomes
Individual components of cardiac events
Time frame: Assessed at 12 months post-discharge
LDL-C level
Time frame: Assessed at 12 months post-discharge
LDL-C Goal Attainment
Time frame: Assessed at 12 months post-discharge
Blood pressure level
Time frame: Assessed at 12 months post-discharge
Blood pressure goal attainment
Time frame: Assessed at 12 months post-discharge
Hemoglobin A1c level
Time frame: Assessed at 12 months post-discharge
Smoking
Time frame: Assessed at 12 months post-discharge
Medication adherence to antiplatelet agents and statins
Time frame: Assessed at 12 months post-discharge
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 18 Aug 2026.
- 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.
16 sites 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 Premature Coronary Heart Disease, run by China National Center for Cardiovascular Diseases at 16 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 3 inclusion and 5 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 18 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 16 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 Gao 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?
Cardiovascular Composite Endpoint Events (time frame: Assessed at 12 months post-discharge). 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 18 Aug 2026.