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Establish a Telecare Model of Acute Coronary Syndrome Patient With Heart Stent Implantation by a Non-invasive Wearable Device and Artificial Intelligence Cloud to Reducing Medical Adverse Events.

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ClinicalTrials.gov Identifier: NCT04455568
Recruitment Status : Not yet recruiting
First Posted : July 2, 2020
Last Update Posted : July 23, 2020
Sponsor:
Collaborators:
Taipei Medical University WanFang Hospital
Taipei Medical University Hospital
Taipei Medical University
Lotung Poh-Ai Hospital
Information provided by (Responsible Party):
Taipei Medical University Shuang Ho Hospital

Brief Summary:

Heart disease is still one of the world's most important health problems, and it ranks second among the top ten causes of death among Taiwan. The main cause of death is acute coronary syndrome, and vascular stent placement is the main treatment method for acute coronary syndrome. The probability of restenosis in patients within half a year after a general stent is as high as 25% to 40%. Re-hospitalization and surgery is a big burden on patients and the country's medical costs. However, a set of convenient and accurate clinical tools to determine the prognosis of patients has not yet been developed. Miniaturized wearable devices have been the mainstream trend in medical development in recent years. ECG and heart sound analysis technology are an easy to used medical device for automatically calculating the parameters including EMAT (electromechanical activation time), S4, S4, SDI (Systolic dyssynchrony index). ECG and heart sound could evaluate the heart function, and has the potential to be an effective tools for prognosis and treatment guidelines. Heart rate variability (HRV) and Accelerationplethysmogram (APG) is also proved the predictive effect the outcome of patients.

This study is start on June 1 2020. We will enroll 400 patients who diagnosis of acute coronary syndrome and have been a heart stent surgery, and registry there medical history,routine examination and medication, ECG and heart, HRV and APG record at admission, pre-discharge and every routine return visit within I year after discharge.Patients will also wear ECG and PPG (Photoplethysmography) band ever day after discharge, and collected the longitutinal data .All subjects will be tracked the medical adverse events in 1 years after discharge, and compare the characteristic and prognosis value of between patients with and without events. Therefore, our purpose of this study is to drive an effective outcome prediction model by non-invasive device, and establish a telecare model of patient with heart stent implantation to reducing medical adverse events.


Condition or disease Intervention/treatment
Acute Coronary Syndrome Percutaneous Transluminal Coronary Angioplasty Device: use EKG Wisdom bracelet

Detailed Description:

This study is open, prospective study, multi-center, randomized controlled trial, unobtrusive research. This study is start on June 1 2020. We will enroll 400 patients who diagnosis of acute coronary syndrome and have been a heart stent surgery. And random allocation 200 experimental group (Non-invasive Wearable Device) and 200 control group (routine medical).

Ask whether the patients who meet the exclusion criteria are willing to participate in the screening (Screening), if they are willing to join and sign the consent of the subject, and after the patient's condition is stable, conduct an electrocardiogram (V0) before discharge from the hospital. On day 7 (±2 weeks), day 84 (±4 weeks), 168 days (±4 weeks), 252 days (±4 weeks), 336 days (±8 weeks) during routine clinical referral (V1-V5) Both are done once. The results of these two tests and other basic information of the patient, including Demography, Vital Signs, High, Weight, Medication, and European and Taiwan Cardiology Association recommended routine test results of high-risk patients, including Blood Chemistry Panel, NT-proBNP, Echocardiography, Myocardial Perfusion Scan, etc., will record the information of the logged-in subjects on the paper case report form. The CRF (case report form) only displays the study number, and no subject is available. In addition to the examination of each return visit, the subjects also took the ECG bracelet home at the time of discharge (V0) and wore it every day. After the discharge, the ECG was measured every morning and evening, and their personal activity and sleep were collected. Relevant information. After the subject was discharged from the hospital, the subject tracked the date of all adverse events due to cardiovascular disease within one year, including: heart failure, restenosis due to blood vessel, and non-fatal myocardial infarction , To do blood vessel-related surgery again, and data on the occurrence of death.

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Study Type : Observational [Patient Registry]
Estimated Enrollment : 400 participants
Observational Model: Other
Time Perspective: Prospective
Target Follow-Up Duration: 1 Year
Official Title: Establish a Telecare Model of Acute Coronary Syndrome Patient With Heart Stent Implantation by a Non-invasive Wearable Device and Artificial Intelligence Cloud System to Heart Failure Monitoring and Reducing Medical Adverse Events.
Estimated Study Start Date : July 20, 2020
Estimated Primary Completion Date : July 20, 2022
Estimated Study Completion Date : July 20, 2024

Group/Cohort Intervention/treatment
experimental group
Non-invasive Wearable Device, use ECG Wisdom bracelet
Device: use EKG Wisdom bracelet
Non-invasive Wearable Device (use EKG Wisdom bracelet)
Other Name: control group (routine medical)




Primary Outcome Measures :
  1. death [ Time Frame: Within a year ]
    death

  2. Restenosis [ Time Frame: Within a year ]
    Restenosis

  3. heart failure [ Time Frame: Within a year ]
    heart failure


Secondary Outcome Measures :
  1. heart disease re-hospitalization [ Time Frame: Within a year ]
    heart disease re-hospitalization

  2. Stroke re-hospitalization [ Time Frame: Within a year ]
    Stroke re-hospitalization

  3. Arrhythmia re-hospitalization [ Time Frame: Within a year ]
    Arrhythmia re-hospitalization

  4. Physician adjusts medicine [ Time Frame: Within a year ]
    Physician adjusts medicine

  5. Physician arranges examination early [ Time Frame: Within a year ]
    Physician arranges examination early

  6. Medical Compliance [ Time Frame: Within a year ]
    Judged by the physician, when the patient returns to the consultation, the patient is asked about the compliance with the drug in the past, divided into presence and absence

  7. Medical Costs [ Time Frame: Within a year ]
    The sum of all medical and health insurance expenses of the patient in the past year



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   20 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
We will enroll 400 patients who diagnosis of acute coronary syndrome and have been a heart stent surgery. And random allocation 200 experimental group (Non-invasive Wearable Device) and 200 control group (routine medical).
Criteria

Inclusion Criteria:

  1. ≥ 20-year-old
  2. Patients performing general metal stent surgery
  3. Diagnosis of Acute Coronary Syndrome
  4. Willing to sign the consent form of the subject and cooperate with the return visit
  5. Those who are admitted to the hospital and enter the general ward can receive the first ECG heart sound examination

Exclusion Criteria:

  1. <20-year-old
  2. Before the stent was installed, the same blood vessel had been used in patients with PCI (percutaneous coronary intervention) and CABG (Coronary artery bypass graft).
  3. Those who cannot perform the first examination after being admitted to the hospital and entering the general ward
  4. It is impossible to measure the group of ECG and heart sounds. For example, when using Pacemaker, the ECG showed ventricular tachycardia (VT) and Dextrocardia on admission.
  5. Patients who are bedridden and have difficulty in cooperating with return visits
  6. Any subject that the physician believes is at high risk for future uncooperative tracking
  7. Direct participants in this program

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04455568


Contacts
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Contact: Ju-Chi Liu, MD 886-2-22490088 ext 8170 liumdcv@tmu.edu.tw
Contact: Yu-Ann FANG, MS 886-2-22490088 ext 8891 runawayyu@hotmail.com

Sponsors and Collaborators
Taipei Medical University Shuang Ho Hospital
Taipei Medical University WanFang Hospital
Taipei Medical University Hospital
Taipei Medical University
Lotung Poh-Ai Hospital
Investigators
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Principal Investigator: Ju-Chi Liu, MD Chief, Internal of Medicine
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Responsible Party: Taipei Medical University Shuang Ho Hospital
ClinicalTrials.gov Identifier: NCT04455568    
Other Study ID Numbers: N202004123
First Posted: July 2, 2020    Key Record Dates
Last Update Posted: July 23, 2020
Last Verified: June 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Taipei Medical University Shuang Ho Hospital:
Artificial Intelligence
Non-invasive Wearable Device
Telecare Model of Patient,
Acute Coronary Syndrome
Additional relevant MeSH terms:
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Acute Coronary Syndrome
Syndrome
Disease
Pathologic Processes
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases