"Smart Family Doctor" Assisted Comprehensive Management of Secondary Prevention Among Post Coronary Artery Bypass Graft Patients or Post Percutaneous Coronary Intervention Patients (SMART)

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 Overview

• Status: Recruiting
• Conditions: Hypertension; Diabetes Mellitus; Hyperlipidemia; Post Coronary Artery Bypass Grafting; Post PCI
• Intervention / Treatment: Behavioral: Smart family doctor; Behavioral: Health manager

• Study Type: Interventional
• Enrollment (Estimated): 536
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Lihua Zhang Zhang, PhD; Phone Number: 8601060866780; Email: zhanglihua@fuwai.com

Study Locations

• China
  • Xinjiang
    • Ürümqi, Xinjiang, China, 102300
      • Recruiting
      • Xinjiang's First Affiliated Hospital of medical university
      • Contact: Zhiying Wen; Phone Number: +8618129344576; Email: leilubi@fuwai.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: "Smart family doctor" assisted management plus health managers; "Smart family doctor", an AI-assisted applications with personalized interactions and 3-hour health management guidance from a health manager once a week.	Behavioral: Smart family doctor; 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'.; Behavioral: Health manager; 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.
Placebo Comparator: Usual care: health managers; 3-hour health management guidance from a health manager once a week.	Behavioral: Health manager; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	6-month

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Smoking Rate	The proportion of patients who have smoked within the past month.	6-month
Total cholesterol	Total cholesterol analyzed at central lab.	6-month
LDL-C	LDL-C analyzed at central lab.	6-month
HDL-C	HDL-C analyzed at central lab.	6-month
Triglycerides	Triglycerides analyzed at central lab.	6-month
Small dense LDL-C	Small dense LDL-C analyzed at central lab.	6-month
Lipoprotein (a)	Lipoprotein (a) analyzed at central lab.	6-month
Fasting blood glucose	Fasting blood glucose analyzed at central lab.	6-month
HbA1c	HbA1c levels analyzed at central lab.	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.	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.	6-month
Cognitive function	Cognitive function assessed with the Mini-Cog test. The higher score indicated the better conginition.	6-month
Blood Pressure Control Rate	The proportion of patients with systolic blood pressure less than 130 mmHg and diastolic blood pressure less than 80 mmHg.	6-month
Psychological status	Psychological status evaluated using the 9-item Patient Health Questionnaire (PHQ-9). The higher score indicated the worse psychological status	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.	6-month

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Major adverse cardiovascular events (MACE)	The composite endpoint of cardiovascular death, myocardial infarction, stroke, or hospitalization due to cardiovascular disease.	6-month
C-reactive protein	C-reactive protein (CRP) analyzed at central lab.	6-month
interleukin-6	Interleukin-6 (IL-6) is analyzed at central lab.	6-month
Interleukin-10	Interleukin-10 (IL-10) is analyzed at central lab.	6-month
Interleukin-1β (IL-1β)	Interleukin-1β (IL-1β) is analyzed at central lab.	6-month
tumor necrosis factor-α (TNF-α)	Tumor necrosis factor-α (TNF-α) is analyzed at central lab.	6-month
prostaglandin	prostaglandin (PG) is analyzed at central lab.	6-month
Intercellular adhesion molecule-1	Intercellular adhesion molecule-1 (ICAM-1) is analysed at central lab.	6-month
Von Willebrand factor	Von Willebrand factor (vWF) is analyzed at central lab.	6-month
Urinary albumin-to-creatinine ratio	Urinary albumin-to-creatinine ratio is calculated as urine albumin divided by urine creatinine.	6-month
Urinary sodium excretion rate	Urinary sodium excretion rate is analyzed at central lab.	6-month
BMI	Body mass index (BMI) is calculated as weights (kg) divided by the square of heights (meters).	6-month
Waist circumference	Waist circumference is measured at local site.	6-month
Cost-effectiveness analysis	The incremental cost-effectiveness ratio (ICER): the additional cost per patient achieving target control of hypertension, dyslipidemia, or diabetes.	6-month

Collaborators and Investigators

• Sponsor: China National Center for Cardiovascular Diseases
• Collaborators: Chinese Academy of Medical Sciences, Fuwai Hospital
• Investigators: Principal Investigator: Xin Yuan, PhD, Chinese Academy of Medical Sciences, Fuwai Hospital

Publications and helpful links

General 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.

Study record dates

Study Major Dates

• Study Start (Actual): September 24, 2025
• Primary Completion (Estimated): September 15, 2026
• Study Completion (Estimated): November 15, 2026

Study Registration Dates

• First Submitted: September 21, 2024
• First Submitted That Met QC Criteria: September 24, 2024
• First Posted (Actual): September 26, 2024

Study Record Updates

• Last Update Posted (Actual): December 8, 2025
• Last Update Submitted That Met QC Criteria: December 2, 2025
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Keywords: smartphone; AI-assisted; CABG management; metabolic management; Smart family doctor
• Additional Relevant MeSH Terms: Endocrine System Diseases; Vascular Diseases; Cardiovascular Diseases; Metabolic Diseases; Glucose Metabolism Disorders; Dyslipidemias; Lipid Metabolism Disorders; Nutritional and Metabolic Diseases; Hypertension; Diabetes Mellitus; Hyperlipidemias
• Other Study ID Numbers: FW-YX-001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: 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.
• IPD Sharing Time Frame: At the end of the study
• IPD Sharing Access Criteria: 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.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No