NCT04636996

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
200

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2021

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 26, 2020

Completed
24 days until next milestone

First Posted

Study publicly available on registry

November 19, 2020

Completed
1 month until next milestone

Study Start

First participant enrolled

January 1, 2021

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2022

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2022

Completed
Last Updated

November 19, 2020

Status Verified

November 1, 2020

Enrollment Period

1.7 years

First QC Date

October 26, 2020

Last Update Submit

November 14, 2020

Conditions

Coronary Heart DiseaseArtificial IntelligenceSleep Apnea

Keywords

artificial intelligence

Outcome Measures

Primary Outcomes (1)

  • Heart rate

    The average heart rate during the first 35 days postoperatively

    35 days

Secondary Outcomes (8)

  • Duration of different sleep stages

    35 days

  • Average Pulse oxygen saturation

    35 days

  • Minimum pulse oxygen saturation

    35 days

  • Pain score

    35 days

  • Medication compliance

    35 days

  • +3 more secondary outcomes

Study Arms (2)

artificial intelligence assisted follow-up group

EXPERIMENTAL

artificial intelligence assisted follow-up group

Other: artificial intelligence assisted follow-up

Control group

PLACEBO COMPARATOR

Control group

Other: artificial intelligence assisted follow-up

Interventions

artificial intelligence assisted follow-upOTHER

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 groupartificial intelligence assisted follow-up group

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cardiovascular Institute and Fuwai Hospital, CAMS&PUMC

Beijing, Beijing Municipality, 100037, China

Location

Related Publications (16)

  • 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.

    PMID: 30571361RESULT

  • 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.

    PMID: 25748612RESULT

  • 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.

    PMID: 22951205RESULT

  • 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.

    PMID: 27583372RESULT

  • 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.

    PMID: 22052934RESULT

  • 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.

    PMID: 29961032RESULT

  • 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.

    PMID: 31169429RESULT

  • 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.

    PMID: 22588748RESULT

  • 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.

    PMID: 18375982RESULT

  • 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.

    PMID: 15982594RESULT

  • 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.

    PMID: 22560918RESULT

  • 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.

    PMID: 16845896RESULT

  • 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.

    PMID: 28179398RESULT

  • 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.

    PMID: 3035326RESULT

  • 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.

    PMID: 27571048RESULT

  • 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.

    PMID: 30504110RESULT

MeSH Terms

Conditions

Coronary DiseaseSleep Apnea Syndromes

Condition Hierarchy (Ancestors)

Myocardial IschemiaHeart DiseasesCardiovascular DiseasesVascular DiseasesApneaRespiration DisordersRespiratory Tract DiseasesSleep Disorders, IntrinsicDyssomniasSleep Wake DisordersNervous System Diseases

Study Officials

  • Jia Shi, MD

    National Center for Cardiovascular Disease, China

    STUDY CHAIR

Central Study Contacts

Jia Shi, MD

CONTACT

86-10-88322467shiandypumc@sina.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Deputy director of the anesthesia center

Study Record Dates

First Submitted

October 26, 2020

First Posted

November 19, 2020

Study Start

January 1, 2021

Primary Completion

September 30, 2022

Study Completion

December 31, 2022

Last Updated

November 19, 2020

Record last verified: 2020-11

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)