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

Coronary Heart Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04636996
• Other study ID #: CIFuwaiHospital2019-1220
• Status: Not yet recruiting
• Phase: N/A
• Start date: January 1, 2021
• Est. completion date: December 31, 2022

Study information

• Verified date: November 2020
• Source: Chinese Academy of Medical Sciences, Fuwai Hospital
• Contact: Jia Shi, MD
• Phone: 86-10-88322467
• Email: shiandypumc[@]sina.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 200
• Est. completion date: December 31, 2022
• Est. primary completion date: September 30, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Artificial Intelligence
• Coronary Artery Disease
• Coronary Disease
• Coronary Heart Disease
• Heart Diseases
• Myocardial Ischemia
• Sleep Apnea

Intervention

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

Locations

Country	Name	City	State
China	Cardiovascular Institute and Fuwai Hospital, CAMS&PUMC	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Chinese Academy of Medical Sciences, Fuwai Hospital

Country where clinical trial is conducted

China, 

References & Publications (16)

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Smith SC Jr, Benjamin EJ, Bonow RO, Braun LT, Creager MA, Franklin BA, Gibbons RJ, Grundy SM, Hiratzka LF, Jones DW, Lloyd-Jones DM, Minissian M, Mosca L, Peterson ED, Sacco RL, Spertus J, Stein JH, Taubert KA; World Heart Federation and the Preventive Ca — View Citation

Wu ZK, Vikman S, Laurikka J, Pehkonen E, Iivainen T, Huikuri HV, Tarkka MR. Nonlinear heart rate variability in CABG patients and the preconditioning effect. Eur J Cardiothorac Surg. 2005 Jul;28(1):109-13. Epub 2005 Apr 8. — View Citation

* Note: There are 16 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Heart rate	The average heart rate during the first 35 days postoperatively	35 days
Secondary	Duration of different sleep stages	It includes duration of falling asleep, light sleep, and deep sleep period	35 days
Secondary	Average Pulse oxygen saturation	The average pulse oxygen saturation during the sleep will be evaluated by the sleep monitor device automatically.	35 days
Secondary	Minimum pulse oxygen saturation	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
Secondary	Pain score	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
Secondary	Medication compliance	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
Secondary	Re-admission rate	It is defined as re-admission between discharge to 35 days after surgery.	35 days
Secondary	All-cause mortality	refers to the incidence of death from the day of surgery to the end of the trial, regardless of the cause.	35 days
Secondary	Total cost of medical expenses	It refers to the total medical expenses for CABG surgery and the following follow-up process.	35 days