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NCT Number: NCT06615609

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

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.

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Key information

Conditions

Post Coronary Artery Bypass Grafting Cardiovascular Diseases Diabetes Mellitus Dyslipidemias Endocrine System Diseases Glucose Metabolism Disorders Hyperlipidemia Hyperlipidemias Hypertension Lipid Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases Post PCI Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Xinjiang's First Affiliated Hospital of medical university

Ürümqi, Xinjiang, 102300, China

Location status: Recruiting

Location contact

Zhiying Wen

CONTACT

[email protected]

+8618129344576

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Smart family doctor

Behavioral

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 manager

Behavioral

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.

Primary outcomes

  1. The control rates of hypertension, diabetes and hyperlipidemia

    Time frame: 6-month

    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.

Secondary outcomes

  1. Blood Pressure Control Rate

    Time frame: 6-month

    The proportion of patients with systolic blood pressure less than 130 mmHg and diastolic blood pressure less than 80 mmHg.

  2. Smoking Rate

    Time frame: 6-month

    The proportion of patients who have smoked within the past month.

  3. Total cholesterol

    Time frame: 6-month

    Total cholesterol analyzed at central lab.

  4. LDL-C

    Time frame: 6-month

    LDL-C analyzed at central lab.

  5. HDL-C

    Time frame: 6-month

    HDL-C analyzed at central lab.

  6. Triglycerides

    Time frame: 6-month

    Triglycerides analyzed at central lab.

  7. Small dense LDL-C

    Time frame: 6-month

    Small dense LDL-C analyzed at central lab.

  8. Lipoprotein (a)

    Time frame: 6-month

    Lipoprotein (a) analyzed at central lab.

  9. Fasting blood glucose

    Time frame: 6-month

    Fasting blood glucose analyzed at central lab.

  10. HbA1c

    Time frame: 6-month

    HbA1c levels analyzed at central lab.

  11. Physical Activity Level

    Time frame: 6-month

    Assessed using the International Physical Activity Questionnaire (IPAQ) and decribed as total MET of walking, moderate, or high intensity physical activity.

  12. Quality of life using the Short Form Health Survey (SF-12v2)

    Time frame: 6-month

    Quality of life using the Short Form Health Survey (SF-12v2). The higher score indicated the better quality of life.

  13. Coronary artery disease-related quality of life

    Time frame: 6-month

    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.

  14. Psychological status

    Time frame: 6-month

    Psychological status evaluated using the 9-item Patient Health Questionnaire (PHQ-9). The higher score indicated the worse psychological status

  15. Cognitive function

    Time frame: 6-month

    Cognitive function assessed with the Mini-Cog test. The higher score indicated the better conginition.

Other outcomes

  1. Major adverse cardiovascular events (MACE)

    Time frame: 6-month

    The composite endpoint of cardiovascular death, myocardial infarction, stroke, or hospitalization due to cardiovascular disease.

  2. C-reactive protein

    Time frame: 6-month

    C-reactive protein (CRP) analyzed at central lab.

  3. interleukin-6

    Time frame: 6-month

    Interleukin-6 (IL-6) is analyzed at central lab.

  4. Interleukin-10

    Time frame: 6-month

    Interleukin-10 (IL-10) is analyzed at central lab.

  5. Interleukin-1β (IL-1β)

    Time frame: 6-month

    Interleukin-1β (IL-1β) is analyzed at central lab.

  6. tumor necrosis factor-α (TNF-α)

    Time frame: 6-month

    Tumor necrosis factor-α (TNF-α) is analyzed at central lab.

  7. prostaglandin

    Time frame: 6-month

    prostaglandin (PG) is analyzed at central lab.

  8. Intercellular adhesion molecule-1

    Time frame: 6-month

    Intercellular adhesion molecule-1 (ICAM-1) is analysed at central lab.

  9. Von Willebrand factor

    Time frame: 6-month

    Von Willebrand factor (vWF) is analyzed at central lab.

  10. Urinary albumin-to-creatinine ratio

    Time frame: 6-month

    Urinary albumin-to-creatinine ratio is calculated as urine albumin divided by urine creatinine.

  11. Urinary sodium excretion rate

    Time frame: 6-month

    Urinary sodium excretion rate is analyzed at central lab.

  12. BMI

    Time frame: 6-month

    Body mass index (BMI) is calculated as weights (kg) divided by the square of heights (meters).

  13. Waist circumference

    Time frame: 6-month

    Waist circumference is measured at local site.

  14. Cost-effectiveness analysis

    Time frame: 6-month

    The incremental cost-effectiveness ratio (ICER): the additional cost per patient achieving target control of hypertension, dyslipidemia, or diabetes.

Study contacts

Contact information is provided by the study sponsor or research team.

Lihua Zhang Zhang, PhD

CONTACT

[email protected]

8601060866780

Sponsors and collaborators

Lead sponsor

China National Center for Cardiovascular Diseases

Other Gov

Collaborators

  • Chinese Academy of Medical Sciences, Fuwai Hospital

Registry information

Acronym: SMART

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Sep 26, 2024
Registry last updated
Dec 8, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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