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Coronary Heart DiseaseNCT04636996

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

A study testing artificial intelligence assisted follow-up in people with Coronary Heart Disease and Artificial Intelligence, run by Chinese Academy of Medical Sciences, Fuwai Hospital at 1 site in China.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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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… Read more about this study

Who is it for?
Ages 18 to 70 years
What is being tested?
artificial intelligence assisted follow-up
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
200 participants
Where
1 siteChina
Study dates
1 Jan 2021to 31 Dec 2022
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 70 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

Jia Shi, MD contact

86-10-88322467

shiandypumc@sina.com

China1 site

  • Cardiovascular Institute and Fuwai Hospital, CAMS&PUMC

    Beijing, Beijing Municipality, 100037

Other trials in China

About this study

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

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.

Read the 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.

Being tested
artificial intelligence assisted follow-up
Keywords
artificial intelligence
Medical subject headings
Coronary Disease, Sleep Apnea Syndromes

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • 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

Study groups in NCT04636996
Study groupRoleWhat they receive
artificial intelligence assisted follow-up groupExperimentalartificial intelligence assisted follow-up group
Receives: Other: artificial intelligence assisted follow-up
Control groupPlacebo comparatorControl group
Receives: Other: artificial intelligence assisted follow-up

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Heart rate

    The average heart rate during the first 35 days postoperatively

    Measured: 35 days

Secondary outcomes (8)

  1. Duration of different sleep stages

    It includes duration of falling asleep, light sleep, and deep sleep period

    Measured: 35 days

  2. Average Pulse oxygen saturation

    The average pulse oxygen saturation during the sleep will be evaluated by the sleep monitor device automatically.

    Measured: 35 days

  3. 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.

    Measured: 35 days

  4. 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.

    Measured: 35 days

  5. 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.

    Measured: 35 days

  6. Re-admission rate

    It is defined as re-admission between discharge to 35 days after surgery.

    Measured: 35 days

  7. All-cause mortality

    refers to the incidence of death from the day of surgery to the end of the trial, regardless of the cause.

    Measured: 35 days

  8. Total cost of medical expenses

    It refers to the total medical expenses for CABG surgery and the following follow-up process.

    Measured: 35 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 Nov 2020
  2. Study start1 Jan 2021 (estimated)
  3. Primary completion30 Sep 2022 (estimated)
  4. Study completion31 Dec 2022 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Health services research
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
200 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04636996
Sponsor's protocol ID
CIFuwaiHospital2019-1220
Status last verified
Nov 2020
First submitted
26 Oct 2020
Last updated
19 Nov 2020
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 30571361

  • 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.

    PubMed 25748612

  • 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.

    PubMed 22951205

  • 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.

    PubMed 27583372

  • 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.

    PubMed 22052934

  • 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.

    PubMed 29961032

  • 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.

    PubMed 31169429

  • 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.

    PubMed 22588748

  • 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.

    PubMed 18375982

  • 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.

    PubMed 15982594

  • 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.

    PubMed 22560918

  • 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.

    PubMed 16845896

  • 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.

    PubMed 28179398

  • 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.

    PubMed 3035326

  • 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.

    PubMed 27571048

Questions about this trial

What is this clinical trial studying?

A study testing artificial intelligence assisted follow-up in people with Coronary Heart Disease and Artificial Intelligence, run by Chinese Academy of Medical Sciences, Fuwai Hospital at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 19 Nov 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Jia Shi, MD (86-10-88322467, shiandypumc@sina.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Heart rate (time frame: 35 days). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04636996, which also lists 16 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Nov 2020.

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