"Smart Family Doctor" Assisted Comprehensive Management of Secondary Prevention Among Post Revascularization Patients (SMART II)

December 10, 2025 updated by: Xin Yuan, China National Center for Cardiovascular Diseases
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-revascularization patients. A randomized controlled trial design will be used, involving approximately 10-20 hospitals and 951 participants. Eligible participants are adults aged between 18 and 80 years, post-CABG or post-PCI patients with hypertension, diabetes, and dyslipidemia.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
951

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Age 18-80 years.
  • Underwent CABG or PCI more than 3 months prior and have concurrent 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
  • 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.
  • Unable to use smartphone.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: "Smart family doctor" assisted management
"Smart family doctor", an AI-assisted applications with personalized interactions in 24 hours and 7 days a week.
Behavioral: Smart family doctor
Participants will be 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'.
Experimental: 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.
Placebo Comparator: Usual care
Usual post-surgery management
Behavioral: Usual Care
Participants will receive usual secondary prevention management.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
6-month

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Smoking Rate
Time Frame: 6-month
The proportion of patients who have smoked within the past month.
6-month
Total cholesterol
Time Frame: 6-month
Total cholesterol analyzed at central lab.
6-month
LDL-C
Time Frame: 6-month
LDL-C analyzed at central lab.
6-month
HDL-C
Time Frame: 6-month
HDL-C analyzed at central lab.
6-month
Triglycerides
Time Frame: 6-month
Triglycerides analyzed at central lab.
6-month
Fasting blood glucose
Time Frame: 6-month
Fasting blood glucose analyzed at central lab.
6-month
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.
6-month
Blood glucose Control Rate
Time Frame: 6-month
The proportion of patients with HbA1c less than 7%.
6-month
Blood lipid Control Rate
Time Frame: 6-month
The proportion of patients with LDL-C less than 1.4mmol/L.
6-month
Systolic blood pressure
Time Frame: 6-month
Systolic blood pressure measured at the local site.
6-month
Diastolic blood pressure
Time Frame: 6-month
Diastolic blood pressure measured at the local site.
6-month
HbA1c
Time Frame: 6-month
HbA1c analyzed at central lab.
6-month
Medication adherence (4-item Morisky Medication-Taking Adherence Scale)
Time Frame: 6-month
Medication adherence measured by MMAS-4. The score range from 0 to 4. The higher score indicated the better medication adherence.
6-month
Coronary artery disease-related quality of life (the Seattle Angina Questionnaire)
Time Frame: 6-month
Coronary artery disease-related quality of life assessed with the Seattle Angina Questionnaire (SAQ). The score range from 0 to 100. The higher score indicated the better coronary artery disease-related quality of life.
6-month

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Major adverse cardiovascular events (MACE)
Time Frame: 6-month
The composite endpoint of cardiovascular death, myocardial infarction, stroke, or hospitalization due to cardiovascular disease.
6-month
BMI
Time Frame: 6-month
Body mass index (BMI) is calculated as weights (kg) divided by the square of heights (meters).
6-month
Waist circumference
Time Frame: 6-month
Waist circumference is measured at local site.
6-month
Rehospitalization rate
Time Frame: 6-month
The proportion of patients who had hospitalization
6-month
The number of emergency visit
Time Frame: 6-month
The number of emergency visit during follow-up period
6-month
Subgroup-age
Time Frame: 6-month
Primary outcome analyses in age subgroups: <=65, >65 years
6-month
Subgroup-sex
Time Frame: 6-month
Primary outcome analyses in sex subgroups: women, men
6-month
Subgroup-education level
Time Frame: 6-month
Primary outcome analyses in education level subgroups: less than high school, high school or higher
6-month
Subgroup-smoking status
Time Frame: 6-month
Primary outcome analyses in smoking status subgroups: current smoking, no smoking
6-month
Subgroup-baseline BP level
Time Frame: 6-month
Primary outcome analyses in baseline BP level subgroups: SBP/DBP>=130/80 mmHg, <130/80 mmHg
6-month
Subgroup-baseline LDL-C level
Time Frame: 6-month
Primary outcome analyses in baseline LDL-C level subgroups: <1.4 mmolL, >=1.4 mmol/L
6-month
Subgroup-baseline HbA1c level
Time Frame: 6-month
Primary outcome analyses in baseline HbA1c level subgroups: <7%, >=7%
6-month
System usability (system usability scale)
Time Frame: 6-month
System usability measured by system usability scale. The proportion of patients who scaled system usability more than 68 points.
6-month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
China National Center for Cardiovascular Diseases

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Xin Yuan, PhD, Chinese Academy of Medical Sciences, Fuwai Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 15, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 31, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 15, 2027

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 27, 2025

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 27, 2025

First Posted (Estimated)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
December 9, 2025

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
December 18, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 10, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
December 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • FW-YX-002

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 II 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 II 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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