Back to resultsEffects of AI Assisted Follow-up Strategy on Secondary Prevention in CABG Patients
Primary Purpose
Coronary Heart Disease, Artificial Intelligence, Sleep Apnea
Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
artificial intelligence assisted follow-up
Sponsored by
About this trial
This is an interventional health services research trial for Coronary Heart Disease focused on measuring artificial intelligence
Eligibility Criteria
Inclusion Criteria:
- Age between 18-70, male or female
- Received isolated CABG procedure due to coronary artery disease
- Having a smartphone and are willing to cooperate
- Signing written informed consent
Exclusion Criteria:
- Patients undergoing CABG + valve replacement surgery
- Postoperative hospital stays more than 10 days (Due to limited postoperative follow-up time and unstable condition such as incision infection, angina, etc.)
- Patients with lung, liver, and kidney failure (Due to organ dysfunction which needs more professional health care and not suitable for this trial)
- Patients with Urinary system diseases (Getting up during sleep, which will interfere with sleep monitoring)
- Patients mentally or legally disabled
- Breastfeeding or pregnant women
- End-stage disease, estimated survival time is less than 3 months
- Participate in other perioperative intervention studies at the same time
Sites / Locations
- Cardiovascular Institute and Fuwai Hospital, CAMS&PUMC
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
artificial intelligence assisted follow-up group
Control group
Arm Description
artificial intelligence assisted follow-up group
Control group
Outcomes
Primary Outcome Measures
Heart rate
The average heart rate during the first 35 days postoperatively
Secondary Outcome Measures
Duration of different sleep stages
It includes duration of falling asleep, light sleep, and deep sleep period
Average Pulse oxygen saturation
The average pulse oxygen saturation during the sleep will be evaluated by the sleep monitor device automatically.
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.
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.
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.
Re-admission rate
It is defined as re-admission between discharge to 35 days after surgery.
All-cause mortality
refers to the incidence of death from the day of surgery to the end of the trial, regardless of the cause.
Total cost of medical expenses
It refers to the total medical expenses for CABG surgery and the following follow-up process.
Full Information
NCT ID
NCT04636996
First Posted
October 26, 2020
Last Updated
November 14, 2020
Sponsor
Chinese Academy of Medical Sciences, Fuwai Hospital
1. Study Identification
Unique Protocol Identification Number
NCT04636996
Brief Title
Effects of AI Assisted Follow-up Strategy on Secondary Prevention in CABG Patients
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
Study Type
Interventional
2. Study Status
Record Verification Date
November 2020
Overall Recruitment Status
Unknown status
Study Start Date
January 1, 2021 (Anticipated)
Primary Completion Date
September 30, 2022 (Anticipated)
Study Completion Date
December 31, 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Chinese Academy of Medical Sciences, Fuwai Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Coronary Heart Disease, Artificial Intelligence, Sleep Apnea
Keywords
artificial intelligence
7. Study Design
Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
200 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
artificial intelligence assisted follow-up group
Arm Type
Experimental
Arm Description
artificial intelligence assisted follow-up group
Arm Title
Control group
Arm Type
Placebo Comparator
Arm Description
Control group
Intervention Type
Other
Intervention Name(s)
artificial intelligence assisted follow-up
Intervention Description
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
Primary Outcome Measure Information:
Title
Heart rate
Description
The average heart rate during the first 35 days postoperatively
Time Frame
35 days
Secondary Outcome Measure Information:
Title
Duration of different sleep stages
Description
It includes duration of falling asleep, light sleep, and deep sleep period
Time Frame
35 days
Title
Average Pulse oxygen saturation
Description
The average pulse oxygen saturation during the sleep will be evaluated by the sleep monitor device automatically.
Time Frame
35 days
Title
Minimum pulse oxygen saturation
Description
The pulse oxygen saturation during the sleep will be recorded by the sleep monitor device and the minimum pulse oxygen saturation will be analyzed.
Time Frame
35 days
Title
Pain score
Description
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.
Time Frame
35 days
Title
Medication compliance
Description
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.
Time Frame
35 days
Title
Re-admission rate
Description
It is defined as re-admission between discharge to 35 days after surgery.
Time Frame
35 days
Title
All-cause mortality
Description
refers to the incidence of death from the day of surgery to the end of the trial, regardless of the cause.
Time Frame
35 days
Title
Total cost of medical expenses
Description
It refers to the total medical expenses for CABG surgery and the following follow-up process.
Time Frame
35 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Age between 18-70, male or female
Received isolated CABG procedure due to coronary artery disease
Having a smartphone and are willing to cooperate
Signing written informed consent
Exclusion Criteria:
Patients undergoing CABG + valve replacement surgery
Postoperative hospital stays more than 10 days (Due to limited postoperative follow-up time and unstable condition such as incision infection, angina, etc.)
Patients with lung, liver, and kidney failure (Due to organ dysfunction which needs more professional health care and not suitable for this trial)
Patients with Urinary system diseases (Getting up during sleep, which will interfere with sleep monitoring)
Patients mentally or legally disabled
Breastfeeding or pregnant women
End-stage disease, estimated survival time is less than 3 months
Participate in other perioperative intervention studies at the same time
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jia Shi, MD
Phone
86-10-88322467
Email
shiandypumc@sina.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jia Shi, MD
Organizational Affiliation
National Center for Cardiovascular Disease, China
Official's Role
Study Chair
Facility Information:
Facility Name
Cardiovascular Institute and Fuwai Hospital, CAMS&PUMC
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100037
Country
China
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
30571361
Citation
Shen C, Ge J. Epidemic of Cardiovascular Disease in China: Current Perspective and Prospects for the Future. Circulation. 2018 Jul 24;138(4):342-344. doi: 10.1161/CIRCULATIONAHA.118.033484. No abstract available.
Results Reference
result
PubMed Identifier
25748612
Citation
Mega JL, Stitziel NO, Smith JG, Chasman DI, Caulfield M, Devlin JJ, Nordio F, Hyde C, Cannon CP, Sacks F, Poulter N, Sever P, Ridker PM, Braunwald E, Melander O, Kathiresan S, Sabatine MS. Genetic risk, coronary heart disease events, and the clinical benefit of statin therapy: an analysis of primary and secondary prevention trials. Lancet. 2015 Jun 6;385(9984):2264-2271. doi: 10.1016/S0140-6736(14)61730-X. Epub 2015 Mar 4.
Results Reference
result
PubMed Identifier
22951205
Citation
Hogh AL. The use of secondary medical prevention after primary vascular reconstruction: studies on usage and effectiveness. Dan Med J. 2012 Sep;59(9):B4514.
Results Reference
result
PubMed Identifier
27583372
Citation
Kulik A. Secondary prevention after coronary artery bypass graft surgery: a primer. Curr Opin Cardiol. 2016 Nov;31(6):635-643. doi: 10.1097/HCO.0000000000000331.
Results Reference
result
PubMed Identifier
22052934
Citation
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 Cardiovascular Nurses Association. AHA/ACCF Secondary Prevention and Risk Reduction Therapy for Patients with Coronary and other Atherosclerotic Vascular Disease: 2011 update: a guideline from the American Heart Association and American College of Cardiology Foundation. Circulation. 2011 Nov 29;124(22):2458-73. doi: 10.1161/CIR.0b013e318235eb4d. Epub 2011 Nov 3. No abstract available. Erratum In: Circulation. 2015 Apr 14;131(15):e408.
Results Reference
result
PubMed Identifier
29961032
Citation
Dorje T, Zhao G, Scheer A, Tsokey L, Wang J, Chen Y, Tso K, Tan BK, Ge J, Maiorana A. SMARTphone and social media-based Cardiac Rehabilitation and Secondary Prevention (SMART-CR/SP) for patients with coronary heart disease in China: a randomised controlled trial protocol. BMJ Open. 2018 Jun 30;8(6):e021908. doi: 10.1136/bmjopen-2018-021908.
Results Reference
result
PubMed Identifier
31169429
Citation
Pradeepa R, Rajalakshmi R, Mohan V. Use of Telemedicine Technologies in Diabetes Prevention and Control in Resource-Constrained Settings: Lessons Learned from Emerging Economies. Diabetes Technol Ther. 2019 Jun;21(S2):S29-S216. doi: 10.1089/dia.2019.0038.
Results Reference
result
PubMed Identifier
22588748
Citation
Hawker GA, Mian S, Kendzerska T, French M. Measures of adult pain: Visual Analog Scale for Pain (VAS Pain), Numeric Rating Scale for Pain (NRS Pain), McGill Pain Questionnaire (MPQ), Short-Form McGill Pain Questionnaire (SF-MPQ), Chronic Pain Grade Scale (CPGS), Short Form-36 Bodily Pain Scale (SF-36 BPS), and Measure of Intermittent and Constant Osteoarthritis Pain (ICOAP). Arthritis Care Res (Hoboken). 2011 Nov;63 Suppl 11:S240-52. doi: 10.1002/acr.20543. No abstract available.
Results Reference
result
PubMed Identifier
18375982
Citation
Kolloch R, Legler UF, Champion A, Cooper-Dehoff RM, Handberg E, Zhou Q, Pepine CJ. Impact of resting heart rate on outcomes in hypertensive patients with coronary artery disease: findings from the INternational VErapamil-SR/trandolapril STudy (INVEST). Eur Heart J. 2008 May;29(10):1327-34. doi: 10.1093/eurheartj/ehn123. Epub 2008 Mar 29.
Results Reference
result
PubMed Identifier
15982594
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. doi: 10.1016/j.ejcts.2005.03.011. Epub 2005 Apr 8.
Results Reference
result
PubMed Identifier
22560918
Citation
Lakusic N, Mahovic D, Sonicki Z, Slivnjak V, Baborski F. Outcome of patients with normal and decreased heart rate variability after coronary artery bypass grafting surgery. Int J Cardiol. 2013 Jun 20;166(2):516-8. doi: 10.1016/j.ijcard.2012.04.040. Epub 2012 May 5.
Results Reference
result
PubMed Identifier
16845896
Citation
Cox JL, Bata IR, Gregor RD, Johnstone DE, Wolf HK. Trends in event rate and case fatality of patients hospitalized with myocardial infarction between 1984 and 2001. Can J Physiol Pharmacol. 2006 Jan;84(1):121-7. doi: 10.1139/Y05-141.
Results Reference
result
PubMed Identifier
28179398
Citation
Lindahl B, Baron T, Erlinge D, Hadziosmanovic N, Nordenskjold A, Gard A, Jernberg T. Medical Therapy for Secondary Prevention and Long-Term Outcome in Patients With Myocardial Infarction With Nonobstructive Coronary Artery Disease. Circulation. 2017 Apr 18;135(16):1481-1489. doi: 10.1161/CIRCULATIONAHA.116.026336. Epub 2017 Feb 8.
Results Reference
result
PubMed Identifier
3035326
Citation
Roberts DM, Zimmer WE, Watterson DM. The use of synthetic oligodeoxyribonucleotides in the examination of calmodulin gene and protein structure and function. Methods Enzymol. 1987;139:290-303. doi: 10.1016/0076-6879(87)39093-7. No abstract available.
Results Reference
result
PubMed Identifier
27571048
Citation
McEvoy RD, Antic NA, Heeley E, Luo Y, Ou Q, Zhang X, Mediano O, Chen R, Drager LF, Liu Z, Chen G, Du B, McArdle N, Mukherjee S, Tripathi M, Billot L, Li Q, Lorenzi-Filho G, Barbe F, Redline S, Wang J, Arima H, Neal B, White DP, Grunstein RR, Zhong N, Anderson CS; SAVE Investigators and Coordinators. CPAP for Prevention of Cardiovascular Events in Obstructive Sleep Apnea. N Engl J Med. 2016 Sep 8;375(10):919-31. doi: 10.1056/NEJMoa1606599. Epub 2016 Aug 28.
Results Reference
result
PubMed Identifier
30504110
Citation
Otto-Yanez M, Torres-Castro R, Nieto-Pino J, Mayos M. [Obstructive sleep apnea-hypopnea and stroke]. Medicina (B Aires). 2018;78(6):427-435. Spanish.
Results Reference
result
Learn more about this trial
Effects of AI Assisted Follow-up Strategy on Secondary Prevention in CABG Patients
We'll reach out to this number within 24 hrs