Post Coronary Artery Bypass GraftingSMARTNCT06615609
"Smart Family Doctor" Assisted Comprehensive Management of Secondary Prevention Among Post Coronary Artery Bypass Graft Patients or Post Percutaneous Coronary Intervention Patients
A study testing Smart family doctor and Health manager in people with Post Coronary Artery Bypass Grafting and Hypertension, run by China National Center for Cardiovascular Diseases at 1 site in China.
Trial summary
This study aims to evaluate the effect of an AI-assisted "Smart family doctor" digital health management tool on improving the control rates of hypertension, diabetes, and dyslipidemia in post-CABG (coronary artery bypass grafting) patients or post-PCI (percutaneous coronary intervention) patients. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Post Coronary Artery Bypass Grafting, Hypertension, Diabetes Mellitus
- What is being tested?
- Smart family doctor and Health manager
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 536 participants
- Where
- 1 siteChina
- Study dates
- 24 Sep 2025to 15 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
- Age ≥ 18 years.
- History of CABG surgery or PCI with history of hypertension, diabetes, and dyslipidemia.
- At least one of the following criteria is meet:
- Systolic blood pressure no less than 130 mmHg or diastolic blood pressure no less than 80 mmHg
- HbA1c no less than 7%
- LDL-C no less than 1.4 mmol/L
- Use of a smartphone.
- Signed informed consent.
Who cannot join
- History of heart failure or severe arrhythmias.
- Presence of other severe underlying conditions such as cancer or liver and kidney insufficiency.
- Pregnancy, lactation, or plans for pregnancy within the next year.
- Cognitive, communication impairments, or limitations in daily activities.
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
Xinjiang's First Affiliated Hospital of medical university
Ürümqi, Xinjiang, 102300
Zhiying Wen, +8618129344576, leilubi@fuwai.com
About this study
This study aims to evaluate the effect of an AI-assisted "Smart family doctor" digital health management tool on improving the control rates of hypertension, diabetes, and dyslipidemia in post-CABG (coronary artery bypass grafting) patients or post-PCI (percutaneous coronary intervention) patients. A randomized controlled trial design will be used, involving approximately 5-10 hospitals and 536 participants. Eligible participants are adults aged 18 or older, post-CABG or post-PCI patients with hypertension, diabetes, and dyslipidemia.
- Conditions
- Post Coronary Artery Bypass Grafting, Hypertension, Diabetes Mellitus, Hyperlipidemia, Post PCI
- Being tested
- Smart family doctor, Health manager
- Keywords
- smartphone, AI-assisted, CABG management, metabolic management, Smart family doctor
- Medical subject headings
- Hypertension, Diabetes Mellitus, Hyperlipidemias
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Smart family doctorBehavioural
Based on health managers, participants were additionally provided "Smart family doctor", which is an AI-assisted applications with personalized interactions. The content includes, but is not limited to: (1) General educational content, covering basic health knowledge on diseases, risk factors, and treatment methods; (2) Targeted health information, such as more specific guidance on blood pressure and blood sugar control, medication adherence, exercise, and smoking cessation; (3) Personalized disease management guidance, providing tailored reminders for patients regarding medication, diet, exercise, and medical visits. Patients can also directly report their latest self-measured blood pressure, blood lipid, blood sugar levels, and medication adherence to receive treatment and medication guidance from the 'Smart family doctor'.
Health managerBehavioural
Participants will received 3-hour health management guidance from a health manager once a week, including guidance on healthy lifestyle, medication treatment, and rehabilitation advice. The research team will provide participants with one smart band, requiring them to wear the band daily to collect health data during the 6-month study period.
| Study group | Role | What they receive |
|---|---|---|
| "Smart family doctor" assisted management plus health managers | Experimental | "Smart family doctor", an AI-assisted applications with personalized interactions and 3-hour health management guidance from a health manager once a week. Receives: Behavioral: Smart family doctor; Behavioral: Health manager |
| Usual care: health managers | Placebo comparator | 3-hour health management guidance from a health manager once a week. Receives: Behavioral: Health manager |
What is being measured
The primary outcome is the main question the study is designed to answer.
The control rates of hypertension, diabetes and hyperlipidemia
All cretria are meet:
- Systolic blood pressure less than 130 mmHg and diastolic blood pressure less than 80 mmHg.
- HbA1c less than 7%.
- LDL-C less than 1.4 mmol/L.
Measured: 6-month
Secondary outcomes (15)
Blood Pressure Control Rate
The proportion of patients with systolic blood pressure less than 130 mmHg and diastolic blood pressure less than 80 mmHg.
Measured: 6-month
Smoking Rate
The proportion of patients who have smoked within the past month.
Measured: 6-month
Total cholesterol
Total cholesterol analyzed at central lab.
Measured: 6-month
LDL-C
LDL-C analyzed at central lab.
Measured: 6-month
HDL-C
HDL-C analyzed at central lab.
Measured: 6-month
Triglycerides
Triglycerides analyzed at central lab.
Measured: 6-month
Small dense LDL-C
Small dense LDL-C analyzed at central lab.
Measured: 6-month
Lipoprotein (a)
Lipoprotein (a) analyzed at central lab.
Measured: 6-month
Fasting blood glucose
Fasting blood glucose analyzed at central lab.
Measured: 6-month
HbA1c
HbA1c levels analyzed at central lab.
Measured: 6-month
Physical Activity Level
Assessed using the International Physical Activity Questionnaire (IPAQ) and decribed as total MET of walking, moderate, or high intensity physical activity.
Measured: 6-month
Quality of life using the Short Form Health Survey (SF-12v2)
Quality of life using the Short Form Health Survey (SF-12v2). The higher score indicated the better quality of life.
Measured: 6-month
Coronary artery disease-related quality of life
Coronary artery disease-related quality of life assessed with the Seattle Angina Questionnaire (SAQ). The higher score indicated the better coronary artery disease-related quality of life.
Measured: 6-month
Psychological status
Psychological status evaluated using the 9-item Patient Health Questionnaire (PHQ-9). The higher score indicated the worse psychological status
Measured: 6-month
Cognitive function
Cognitive function assessed with the Mini-Cog test. The higher score indicated the better conginition.
Measured: 6-month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Sep 2024
- Study start24 Sep 2025
- Primary completion15 Sep 2026 (estimated)
- Study completion15 Nov 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 Post Coronary Artery Bypass GraftingStudies 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
- Model description
- The intervention in this study is the implementation of the 'Smart family doctor' system, a digital health management tool designed to support secondary prevention in post-CABG patients or post-PCI patients. This system leverages knowledge from coronary artery disease (CAD) secondary prevention guidelines, expert consensus, and a knowledge base addressing common post-CABG issues. It is powered by a large-scale, medical knowledge-enhanced conversational model, enabling personalized interactions with patients to guide their recovery and lifestyle management following surgery.
- Masking
- None (open label)
- Enrolment
- 536 participants (estimated)
Sponsor and investigators
- Sponsor type
- Other government
- Collaborators
- Chinese Academy of Medical Sciences, Fuwai Hospital
- Responsible party
- Principal investigator, Xin Yuan, China National Center for Cardiovascular Diseases
- Investigators
- Xin Yuan, PhD, Principal investigator, Chinese Academy of Medical Sciences, Fuwai Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06615609
- Sponsor's protocol ID
- FW-YX-001
- Acronym
- SMART
- Status last verified
- Dec 2025
- First submitted
- 21 Sep 2024
- Last updated
- 8 Dec 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Anonymized data that support the findings of this study are available from the corresponding author, upon reasonable request, only for authorized research. Their use is subjected to an agreement with the promotor (Fuwai Hospital) and the principal investigator (Dr Xin Yuan) of the SMART study. Pseudonymised data that support the findings of this study are available from the promotor (Fuwai Hospital) upon reasonable request, subject to a specific agreement with the promotor (involving the principal investigator) and subject to regulatory proceedings due to data protection applicable laws. Access conditions are to be determined depending on the nature of the request.
Publications
Lei L, Li J, Zhang L, Yuan X, Diao X, Qi L, Wang Y, Du W, Zhao W, Hu S. Design and rationale of the artificial intelligent dialogue System assisted comprehensive Management of secondary prevention Among post coronary aRtery bypass graft patienTs (SMART): protocol for a randomised controlled trial for postcoronary artery bypass grafting management. BMJ Open. 2025 Nov 11;15(11):e106447. doi: 10.1136/bmjopen-2025-106447.
PubMed 41218945
Study at a glance
From the registry record, last updated by the sponsor on 8 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- "Smart Family Doctor" Assisted Comprehensive Management of Secondary Prevention Among Post Coronary Artery Bypass Graft Patients or Post Percutaneous Coronary Intervention Patients
- ClinicalTrials.gov ID
- NCT06615609
- Acronym / sponsor ID
- SMART / FW-YX-001
- Conditions
- Post Coronary Artery Bypass Grafting, Hypertension, Diabetes Mellitus, Hyperlipidemia, Post PCI
- Keywords
- smartphone, AI-assisted, CABG management, metabolic management, Smart family doctor
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 536 participants (estimated)
- Lead sponsor
- China National Center for Cardiovascular DiseasesOther government
- Collaborators
- Chinese Academy of Medical Sciences, Fuwai Hospital
- Study start
- 24 Sep 2025 (actual)
- Primary completion
- 15 Sep 2026 (estimated)
- Study completion
- 15 Nov 2026 (estimated)
- First posted
- 26 Sep 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.
This study aims to evaluate the effect of an AI-assisted "Smart family doctor" digital health management tool on improving the control rates of hypertension, diabetes, and dyslipidemia in post-CABG (coronary artery bypass grafting) patients or post-PCI (percutaneous coronary intervention) patients. A randomized controlled trial design will be used, involving approximately 5-10 hospitals and 536 participants. Eligible participants are adults aged 18 or older, post-CABG or post-PCI patients with hypertension, diabetes, and dyslipidemia.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- The intervention in this study is the implementation of the 'Smart family doctor' system, a digital health management tool designed to support secondary prevention in post-CABG patients or post-PCI patients. This system leverages knowledge from coronary artery disease (CAD) secondary prevention guidelines, expert consensus, and a knowledge base addressing common post-CABG issues. It is powered by a large-scale, medical knowledge-enhanced conversational model, enabling personalized interactions with patients to guide their recovery and lifestyle management following surgery.
| Arm | Type | Receives |
|---|---|---|
| "Smart family doctor" assisted management plus health managers | Experimental | Behavioral: Smart family doctor, Behavioral: Health manager"Smart family doctor", an AI-assisted applications with personalized interactions and 3-hour health management guidance from a health manager once a week. |
| Usual care: health managers | Placebo comparator | Behavioral: Health manager3-hour health management guidance from a health manager once a week. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Age ≥ 18 years.
- History of CABG surgery or PCI with history of hypertension, diabetes, and dyslipidemia.
- At least one of the following criteria is meet:
- Systolic blood pressure no less than 130 mmHg or diastolic blood pressure no less than 80 mmHg
- HbA1c no less than 7%
Key exclusion criteria (4 listed)
- History of heart failure or severe arrhythmias.
- Presence of other severe underlying conditions such as cancer or liver and kidney insufficiency.
- Pregnancy, lactation, or plans for pregnancy within the next year.
- Cognitive, communication impairments, or limitations in daily activities.
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 |
|---|---|---|
| Smart family doctorBased on health managers, participants were additionally provided "Smart family doctor", which is an AI-assisted applications with personalized interactions. The content includes, but is not limited to: (1) General educational content, covering basic health knowledge on diseases, risk factors, and treatment methods; (2) Targeted health information, such as more specific guidance on blood pressure and blood sugar control, medication adherence, exercise, and smoking cessation; (3) Personalized disease management guidance, providing tailored reminders for patients regarding medication, diet, exercise, and medical visits. Patients can also directly report their latest self-measured blood pressure, blood lipid, blood sugar levels, and medication adherence to receive treatment and medication guidance from the 'Smart family doctor'. | Behavioural | "Smart family doctor" assisted management plus health managers |
| Health managerParticipants will received 3-hour health management guidance from a health manager once a week, including guidance on healthy lifestyle, medication treatment, and rehabilitation advice. The research team will provide participants with one smart band, requiring them to wear the band daily to collect health data during the 6-month study period. | Behavioural | "Smart family doctor" assisted management plus health managers, Usual care: health managers |
Primary outcome
The control rates of hypertension, diabetes and hyperlipidemia
Time frame: 6-month
All cretria are meet: 1. Systolic blood pressure less than 130 mmHg and diastolic blood pressure less than 80 mmHg. 2. HbA1c less than 7%. 3. LDL-C less than 1.4 mmol/L.
15 secondary outcomes
Blood Pressure Control Rate
Time frame: 6-month
Smoking Rate
Time frame: 6-month
Total cholesterol
Time frame: 6-month
LDL-C
Time frame: 6-month
HDL-C
Time frame: 6-month
Triglycerides
Time frame: 6-month
Small dense LDL-C
Time frame: 6-month
Lipoprotein (a)
Time frame: 6-month
Fasting blood glucose
Time frame: 6-month
HbA1c
Time frame: 6-month
Physical Activity Level
Time frame: 6-month
Quality of life using the Short Form Health Survey (SF-12v2)
Time frame: 6-month
Coronary artery disease-related quality of life
Time frame: 6-month
Psychological status
Time frame: 6-month
Cognitive function
Time frame: 6-month
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 8 Dec 2025.
- Derived from this study: PubMed 41218945Lei L, Li J, Zhang L, Yuan X, Diao X, Qi L, Wang Y, Du W, Zhao W, Hu S. Design and rationale of the artificial intelligent dialogue System assisted comprehensive Management of secondary prevention Among post coronary aRtery bypass graft patienTs (SMART): protocol for a randomised controlled trial for postcoronary artery bypass grafting management. BMJ Open. 2025 Nov 11;15(11):e106447. doi: 10.1136/bmjopen-2025-106447.
- Individual participant dataSharing planned: Yes. Anonymized data that support the findings of this study are available from the corresponding author, upon reasonable request, only for authorized research. Their use is subjected to an agreement with the promotor (Fuwai Hospital) and the principal investigator (Dr Xin Yuan) of the SMART study. Pseudonymised data that support the findings of this study are available from the promotor (Fuwai Hospital) upon reasonable request, subject to a specific agreement with the promotor (involving the principal investigator) and subject to regulatory proceedings due to data protection applicable laws. Access conditions are to be determined depending on the nature of the request.
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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.
Xin Yuan, PhD principal investigator
Chinese Academy of Medical Sciences, Fuwai Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Smart family doctor and Health manager in people with Post Coronary Artery Bypass Grafting and Hypertension, 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 8 inclusion and 4 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 8 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. Some participants in this study may receive a placebo. 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 Lihua Zhang Zhang, PhD (8601060866780, zhanglihua@fuwai.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The control rates of hypertension, diabetes and hyperlipidemia (time frame: 6-month). 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 NCT06615609, 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 8 Dec 2025.