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

NCT ID: NCT04636996

Last Updated: 2020-11-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

200 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-01-01

Study Completion Date

2022-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Coronary Heart Disease Artificial Intelligence Sleep Apnea

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

artificial intelligence

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

artificial intelligence assisted follow-up group

artificial intelligence assisted follow-up group

Group Type EXPERIMENTAL

artificial intelligence assisted follow-up

Intervention Type OTHER

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

Control group

Control group

Group Type PLACEBO_COMPARATOR

artificial intelligence assisted follow-up

Intervention Type OTHER

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Chinese Academy of Medical Sciences, Fuwai Hospital

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

SHI Jia

Deputy director of the anesthesia center

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Jia Shi, MD

Role: STUDY_CHAIR

National Center for Cardiovascular Disease, China

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Cardiovascular Institute and Fuwai Hospital, CAMS&PUMC

Beijing, Beijing Municipality, China

Site Status

Countries

Review the countries where the study has at least one active or historical site.

China

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Jia Shi, MD

Role: CONTACT

Phone: 86-10-88322467

Email: [email protected]

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type RESULT
PMID: 30571361 (View on PubMed)

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.

Reference Type RESULT
PMID: 25748612 (View on PubMed)

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.

Reference Type RESULT
PMID: 22951205 (View on PubMed)

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.

Reference Type RESULT
PMID: 27583372 (View on PubMed)

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.

Reference Type RESULT
PMID: 22052934 (View on PubMed)

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.

Reference Type RESULT
PMID: 29961032 (View on PubMed)

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.

Reference Type RESULT
PMID: 31169429 (View on PubMed)

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.

Reference Type RESULT
PMID: 22588748 (View on PubMed)

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.

Reference Type RESULT
PMID: 18375982 (View on PubMed)

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.

Reference Type RESULT
PMID: 15982594 (View on PubMed)

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.

Reference Type RESULT
PMID: 22560918 (View on PubMed)

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.

Reference Type RESULT
PMID: 16845896 (View on PubMed)

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.

Reference Type RESULT
PMID: 28179398 (View on PubMed)

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.

Reference Type RESULT
PMID: 3035326 (View on PubMed)

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.

Reference Type RESULT
PMID: 27571048 (View on PubMed)

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.

Reference Type RESULT
PMID: 30504110 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

CIFuwaiHospital2019-1220

Identifier Type: -

Identifier Source: org_study_id