ClinicalTrials.gg
RecruitingNCT07031531SMART-CHDUpdated Aug 18, 2026

Effectiveness of an AI-Enabled Stratified Management System for Premature Coronary Artery Disease

An interventional study of AI-Enabled Stratified Management System and Usual Post-Discharge Care in Premature Coronary Heart Disease, sponsored by China National Center for Cardiovascular Diseases. Recruiting at 16 sites in China. Open to participants aged 18 Years to 45 Years. Per ClinicalTrials.gov, last updated 2026-08-18.

Sponsored by China National Center for Cardiovascular Diseases · Not applicable, Interventional, and Prevention

From the registry’s dates

  • Started Aug 2025; still recruiting 1 year 3 months later.
Phase
Not applicable
Study type
Interventional
Enrollment
4,900
Allocation
Randomized
Ages
18 Years to 45 Years
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-12

Among 25 studies in Coronary Disease by China National Center for Cardiovascular Diseases — 12 open to participants now, 13 under way, none of them phase 3. Coronary Disease · China National Center for Cardiovascular Diseases.

Planned enrollment
Largest of 13
4,900 · median 240
Started
2025
with 5 others
No phase
7 of 25
5 open now
Primary completion
2028-08
later than 10 of 12 live
Registered
18th of 25
by date

Among the 25 studies in Coronary Disease by China National Center for Cardiovascular Diseases, this one has the largest planned enrollment of the 13 interventional ones that give a count, is one of 6 that started in 2025, is one of 7 with no phase, reaches primary completion later than 10 of the 12 other live ones, and was the 18th registered.

Coronary Disease

1,520 studies on the registry are indexed under Coronary Disease; 167 are open to participants now.

Browse Coronary Disease studies →

Open to participants now

12 of the 25 studies in Coronary Disease by China National Center for Cardiovascular Diseases are open now, in 1 country. Recruiting first, the newest first:

6 more — sign in →

By country, each count listing its studies:

All 12 open studies →

Where they have run

Who these studies take

Of the 106 Coronary Disease studies recruiting now, 64 (60%) set no upper age limit and 19 (18%) stop at 75 or younger; 8 take children under 18; 10 take healthy volunteers.

This study: 18 Years to 45 Years · all sexes · no healthy volunteers.

The full table on the hub →

This tab as a report to print or save as PDF → With an account.

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Watch this landscapeDownload CSVNarrow it in search →With an account: a weekly mail of what changed among 25 studies in Coronary Disease by China National Center for Cardiovascular Diseases, or all of them as a file.
02

Study 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. Does SMART-CHD reduce the combined rate of all-cause death, myocardial infarction, stroke and rehospitalization within 12 months?
  2. 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:

  1. Install and use the SMART-CHD mobile app after a 10-minute structured orientation session with supervised simulations.
  2. Complete regular in-app surveys on lifestyle behaviors, laboratory/imaging results and clinical events (with OCR-powered LLM assistance).
  3. Wear paired sensors for continuous monitoring of blood pressure, heart rate and other physiologic metrics.
  4. Receive automated EHR data harvesting, AI-driven voice-call reminders, and real-time CRC support via a dedicated WeChat group.
  5. Follow personalized, guideline-based risk-factor recommendations (diet, exercise, sleep, weight, smoking, alcohol, hypertension, dyslipidemia, diabetes).
03

Conditions studied

  • Premature Coronary Heart Disease

Browse trials for

Keywords

  • Premature coronary heart disease
  • secondary prevention
  • long-term management
  • mobile health
  • artificial intelligence
04

Who can participate

Ages eligible
18 Years to 45 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  1. Patients with coronary heart disease aged 18-45 years;
  2. The patient or a close family member is capable of using a smartphone and mobile application (App);
  3. Willing to participate in the study and able to provide written .

Exclusion criteria

Exclusion Criteria

  1. Severe cognitive impairment;
  2. Advanced-stage ;
  3. less than 12 months;
  4. Severe multi-organ failure;
  5. Refusal to provide written .
Terms in these criteria, in plain language(3)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Cancer (malignancy)

Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.

Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.

Life expectancy

The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.

05

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
4,900 participants (estimated)

Study arms

  • Experimental
    AI-Enabled Stratified Management Group

    Participants in the intervention group will use SMART-CHD alongside usual post-discharge care.

    Combination Product: AI-Enabled Stratified Management System · Combination Product: Usual Post-Discharge Care

  • Active comparator
    Usual Post-Discharge Care Group

    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.

    Combination Product: Usual Post-Discharge Care

Interventions

  • Combination productAI-Enabled Stratified Management System

    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.

  • Combination productUsual Post-Discharge Care

    Usual discharge protocol comprising verbal and printed discharge instructions addressing medication schedules, follow-up timelines, and lifestyle optimization strategies.

06

What researchers measure

Primary outcomes

  1. Cardiovascular Composite Endpoint Events

    A composite of all-cause death, myocardial infarction, stroke, and unplanned cardiovascular-related rehospitalization.

    Time frame: Assessed at 12 months post-discharge

Secondary outcomes

  1. Individual components of cardiac events

    All-cause death, myocardial infarction, stroke, and unplanned cardiovascular-related rehospitalization

    Time frame: Assessed at 12 months post-discharge

  2. LDL-C level

    Low-density lipoprotein cholesterol level. Unit of Measure: mmol/L.

    Time frame: Assessed at 12 months post-discharge

  3. LDL-C Goal Attainment

    Achieving LDL-C \< 1.8 mmol/L.

    Time frame: Assessed at 12 months post-discharge

  4. Blood pressure level

    Systolic blood pressure and Diastolic blood pressure. Unit of Measure: mmHg.

    Time frame: Assessed at 12 months post-discharge

  5. Blood pressure goal attainment

    Achieving target BP \<130/80 mmHg.

    Time frame: Assessed at 12 months post-discharge

  6. Hemoglobin A1c level

    Glycated hemoglobin (HbA1c). Unit of Measure: Percentage (%).

    Time frame: Assessed at 12 months post-discharge

  7. Smoking

    Self-reported current smoking status. Unit of Measure: Number and percentage of current smokers

    Time frame: Assessed at 12 months post-discharge

  8. 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

    Time frame: Assessed at 12 months post-discharge

07

Study locations

1 of 16 sites recruiting
08

References and documents

Individual participant data

Plan to share: Yes — Individual participant data (IPD) that underlie the results reported in publications will be shared, including all collected de-identified IPD.

Supporting information: Study protocol, Statistical analysis plan, Informed consent form, Clinical study report, Analytic code

Time frame: Data will be available beginning 6 months after publication of the primary results and will remain available for at least 5 years thereafter.

Access criteria: De-identified IPD and supporting documents will be made available upon reasonable request to the Principal Investigator (PI). Requests must include a methodologically sound proposal and intended use. Access will be granted at the discretion of the PI after review of the request.

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Aug 2025 (actual). Primary completion is estimated for Aug 2028, 36 months after the start.

Of 178 non-industry interventional studies with no phase under Coronary Disease, half reached primary completion within 26 months of starting (the median), counting those still running; a quarter within 15 and three quarters within 51. This study's planned 36 months is above that.

Counting every sponsor, half of 200 studies reached it within 25 months; a quarter within 14 and three quarters within 51.

How these figures are worked out, and which studies are left out of them.

Registered
May 18, 2025
First posted
Jun 22, 2025
StartActual
Aug 8, 2025
Primary completionEst.
Aug 31, 2028
CompletionEst.
Aug 31, 2028
Last update
Aug 18, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Aug 18, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07031531
Responsible party
Sponsor
First posted
Jun 22, 2025
Start date
Aug 8, 2025
Primary completion
Aug 31, 2028 (estimated)
Completion
Aug 31, 2028 (estimated)
Last update
Aug 18, 2026

Study contacts

Gao Prof. Gao, MD, PhD
Contact
sophie_gao@sina.com
010-88322413

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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