Effects of AI Assisted Follow-up Strategy on Secondary Prevention in CABG Patients

November 14, 2020 updated by: SHI Jia, Chinese Academy of Medical Sciences, Fuwai Hospital

Effects of Artificial Intelligence Assisted Follow-up Strategy Based on a New Remote Contactless Sleep Monitoring System on Secondary Prevention in Patients Received Coronary Artery Bypass Grafting Surgery

The present study is trying to find out whether artificial intelligence assisted follow-up strategy will improve secondary prevention in CABG patients. In addition, we will test whether rural patients may have more benefits under the new follow-up strategy based on the artificial intelligence device compared with urban patients.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

There are a large population of coronary heart disease patients in China, which needs more attention to optimize the secondary prevention and improve the prognosis. Secondary prevention has been showing the effects of improving symptoms, preventing disease progression, improving prognosis, and reducing mortality in patients received coronary artery bypass grafting (CABG) surgery. In this study, we are trying to evaluate the effectiveness of artificial intelligence (AI) assisted follow-up strategy on secondary prevention for patients received CABG surgery. And we are trying to find out whether there is difference in secondary prevention of coronary heart disease between urban and rural patients.

Study Type

Interventional

Enrollment (Anticipated)

200

Phase

  • 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 Locations

  • China
    • Beijing
      • Beijing, Beijing, China, 100037
        • Cardiovascular Institute and Fuwai Hospital, CAMS&PUMC

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

Ages Eligible for Study

18 years to 70 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Age between 18-70, male or female
  2. Received isolated CABG procedure due to coronary artery disease
  3. Having a smartphone and are willing to cooperate
  4. Signing written informed consent

Exclusion Criteria:

  1. Patients undergoing CABG + valve replacement surgery
  2. Postoperative hospital stays more than 10 days (Due to limited postoperative follow-up time and unstable condition such as incision infection, angina, etc.)
  3. Patients with lung, liver, and kidney failure (Due to organ dysfunction which needs more professional health care and not suitable for this trial)
  4. Patients with Urinary system diseases (Getting up during sleep, which will interfere with sleep monitoring)
  5. Patients mentally or legally disabled
  6. Breastfeeding or pregnant women
  7. End-stage disease, estimated survival time is less than 3 months
  8. Participate in other perioperative intervention studies at the same time

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: HEALTH_SERVICES_RESEARCH
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: QUADRUPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: artificial intelligence assisted follow-up group
Other: artificial intelligence assisted follow-up
We will use a new portable artificial intelligence assisted device to monitor the patients' postoperative heart rate and sleep quality, guiding the following follow-up process
PLACEBO_COMPARATOR: Control group
Other: artificial intelligence assisted follow-up
We will use a new portable artificial intelligence assisted device to monitor the patients' postoperative heart rate and sleep quality, guiding the following follow-up process

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Heart rate
Time Frame: 35 days
The average heart rate during the first 35 days postoperatively
35 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Duration of different sleep stages
Time Frame: 35 days
It includes duration of falling asleep, light sleep, and deep sleep period
35 days
Average Pulse oxygen saturation
Time Frame: 35 days
The average pulse oxygen saturation during the sleep will be evaluated by the sleep monitor device automatically.
35 days
Minimum pulse oxygen saturation
Time Frame: 35 days
The pulse oxygen saturation during the sleep will be recorded by the sleep monitor device and the minimum pulse oxygen saturation will be analyzed.
35 days
Pain score
Time Frame: 35 days
It will be evaluated with the visual analogue scale from 0 to 10. Zero is the lowest level of pain and 10 is the highest level of pain.
35 days
Medication compliance
Time Frame: 35 days
It will be evaluated with Morisky Medication Adherence Scale (MMAS-4). The patients will receive four questions, which are answered by Yes or No ((Yes=0 and No=1) through the scoring system. Zero is the lowest level of medication adherence and 4 is the highest level of medication adherence.
35 days
Re-admission rate
Time Frame: 35 days
It is defined as re-admission between discharge to 35 days after surgery.
35 days
All-cause mortality
Time Frame: 35 days
refers to the incidence of death from the day of surgery to the end of the trial, regardless of the cause.
35 days
Total cost of medical expenses
Time Frame: 35 days
It refers to the total medical expenses for CABG surgery and the following follow-up process.
35 days

Collaborators and Investigators

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

Sponsor

Chinese Academy of Medical Sciences, Fuwai Hospital

Investigators

  • Study Chair: Jia Shi, MD, National Center for Cardiovascular Disease, China

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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 (ANTICIPATED)

January 1, 2021

Primary Completion (ANTICIPATED)

September 30, 2022

Study Completion (ANTICIPATED)

December 31, 2022

Study Registration Dates

First Submitted

October 26, 2020

First Submitted That Met QC Criteria

November 14, 2020

First Posted (ACTUAL)

November 19, 2020

Study Record Updates

Last Update Posted (ACTUAL)

November 19, 2020

Last Update Submitted That Met QC Criteria

November 14, 2020

Last Verified

November 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CIFuwaiHospital2019-1220

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

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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