<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT04485143</url>
  </required_header>
  <id_info>
    <org_study_id>N202005037</org_study_id>
    <nct_id>NCT04485143</nct_id>
  </id_info>
  <brief_title>Cloud-based ECG Monitoring and Healthcare Model Building on the Population With Coronary Artery Revascularization</brief_title>
  <official_title>Cloud-based ECG Monitoring and Healthcare Model Building on the Population With Coronary Artery Revascularization</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Taipei Medical University Shuang Ho Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Taipei Medical University WanFang Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Taipei Medical University Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Lotung Poh-Ai Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Taipei Medical University Shuang Ho Hospital</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Percutaneous coronary intervention (PCI) and coronary artery bypass graft (CABG) are the&#xD;
      golden treatments for stable coronary artery disease (CAD) combined with heart failure (HF).&#xD;
      The goal of treating HF patients is to prevent repeated hospitalizations and improve&#xD;
      peri-operative survival; clinically, although routines including beta-receptor inhibitors,&#xD;
      angiotensin-converting enzyme (ACE) inhibitors, and mineralocorticoids have been shown&#xD;
      beneficial for the prognosis, for patients with severely low left ventricular ejection rate,&#xD;
      hypotension, and pulmonary disease, the introduction of these drugs in the early&#xD;
      postoperative period should still be cautious and may need to be adjusted with related&#xD;
      cardiovascular function parameters. Patients with low cardiac output syndrome, ventricular&#xD;
      arrhythmia, or hemodynamic instability should be suspected of the failure of bypass grafts if&#xD;
      accompanied by changes in the electrocardiogram (EKG) and an increase in myocardial enzymes.&#xD;
      Intervention should be carried out as soon as possible after angiography detects graft&#xD;
      failure to limit the occurrence of large-scale myocardial injury and prevent the development&#xD;
      of severe myocardial failure.&#xD;
&#xD;
      This study is start on June 1 2020. And will include 400 patients who have just undergone PCI&#xD;
      and 300 CABG patients who diagnosis of stable coronary artery disease. We will register their&#xD;
      medical history, medications, and routine medical examinations within one year, and perform&#xD;
      tests such as phonocardiography (Audiocor). They will be worn and measured daily at home&#xD;
      after discharge. The data of the electrocardiogram and the PPG bracelet will be registered&#xD;
      with their continuous daily values. All subjects tracked the occurrence of adverse medical&#xD;
      events within one year after discharge from the hospital. Based on the home-based remote&#xD;
      personal care model for patients with CABG, a risk prediction model for heart failure and&#xD;
      vascular restenosis was established to effectively reduce medical treatment, adverse events,&#xD;
      and medical expenditure.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This study is open, prospective study, multi-center, randomized controlled trial, unobtrusive&#xD;
      research. This study is start on June 1 2020. And will include 400 patients who have just&#xD;
      undergone PCI and 300 CABG patients who diagnosis of stable coronary artery disease. And&#xD;
      random allocation 350 experimental group (Non-invasive Wearable Device) and 350 control group&#xD;
      (routine medical).&#xD;
&#xD;
      Ask whether the patients who meet the exclusion criteria are willing to participate in the&#xD;
      screening (Screening), if they are willing to join and sign the consent of the subject, and&#xD;
      after the patient's condition is stable, conduct an electrocardiogram (V0) before discharge&#xD;
      from the hospital. On day 7 (±2 weeks), day 84 (±4 weeks), 168 days (±4 weeks), 252 days (±4&#xD;
      weeks), 336 days (±8 weeks) during routine clinical referral (V1-V5) Both are done once. The&#xD;
      results of these two tests and other basic information of the patient, including Demography,&#xD;
      Vital Signs, High, Weight, Medication, and European and Taiwan Cardiology Association&#xD;
      recommended routine test results of high-risk patients, including Blood Chemistry Panel,&#xD;
      NT-proBNP, Echocardiography, Myocardial Perfusion Scan, etc., will record the information of&#xD;
      the logged-in subjects on the paper case report form. The CRF only displays the study number,&#xD;
      and no subject is available. In addition to the examination of each return visit, the&#xD;
      subjects also took the ECG bracelet home at the time of discharge (V0) and wore it every day.&#xD;
      After the discharge, the ECG was measured every morning and evening, and their personal&#xD;
      activity and sleep were collected. Relevant information. After the subject was discharged&#xD;
      from the hospital, the subject tracked the date of all adverse events due to cardiovascular&#xD;
      disease within one year, including: heart failure, restenosis due to blood vessel, and&#xD;
      non-fatal myocardial infarction , To do blood vessel-related surgery again, and data on the&#xD;
      occurrence of death.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Not yet recruiting</overall_status>
  <start_date type="Anticipated">July 20, 2020</start_date>
  <completion_date type="Anticipated">July 20, 2024</completion_date>
  <primary_completion_date type="Anticipated">July 20, 2022</primary_completion_date>
  <study_type>Observational [Patient Registry]</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <target_duration>1 Year</target_duration>
  <primary_outcome>
    <measure>death</measure>
    <time_frame>Within a year</time_frame>
    <description>death, divided into yes or no</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Restenosis</measure>
    <time_frame>Within a year</time_frame>
    <description>Come back to the hospital for PCI or CABG or MI (Judged by the physician) after discharge, divided into yes or no</description>
  </primary_outcome>
  <primary_outcome>
    <measure>heart failure</measure>
    <time_frame>Within a year</time_frame>
    <description>Come back to the hospital for heart failure (Judged by the physician) after discharge, divided into yes or no</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>heart disease re-hospitalization</measure>
    <time_frame>Within a year</time_frame>
    <description>Re-hospitalization for heart disease (Judged by the physician) after discharge, divided into yes or no</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Stroke re-hospitalization</measure>
    <time_frame>Within a year</time_frame>
    <description>Re-hospitalization for Stroke (Judged by the physician) after discharge, divided into yes or no</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Arrhythmia re-hospitalization</measure>
    <time_frame>Within a year</time_frame>
    <description>Re-hospitalization for Arrhythmia (Judged by the physician) after discharge, divided into yes or no</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Physician adjusts medicine</measure>
    <time_frame>Within a year</time_frame>
    <description>According to the medicine order issued by the doctor, if there is any adjustment of the medicine, make a record,divided into yes or no</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Physician arranges examination early</measure>
    <time_frame>Within a year</time_frame>
    <description>If the doctor has arranged to do Cardiac ultrasound or stress &amp; redistribution myocardial perfusion scan with SPECT During non-table period, divided into yes or no</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Compliance</measure>
    <time_frame>Within a year</time_frame>
    <description>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 yes or no</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Medical cost</measure>
    <time_frame>Within a year</time_frame>
    <description>The sum of all medical and health insurance expenses of the patient in the past year</description>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Anticipated">700</enrollment>
  <condition>Coronary Artery Disease</condition>
  <condition>Percutaneous Coronary Intervention</condition>
  <condition>Coronary Artery Bypass Graft</condition>
  <arm_group>
    <arm_group_label>experimental group</arm_group_label>
    <description>Non-invasive Wearable Device</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Wisdom bracelet</intervention_name>
    <description>routine medical</description>
    <arm_group_label>experimental group</arm_group_label>
    <other_name>control group (routine medical)</other_name>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Age&gt;=20,Physician diagnosed with stable coronary artery disease (CAD), accepting PCI&#xD;
        patients with stents or CABG, and willing to sign the subject consent and cooperate with&#xD;
        return. And random allocation 350 experimental group (Non-invasive Wearable Device) and 350&#xD;
        control group (routine medical).&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        Age&gt;=20,Physician diagnosed with stable coronary artery disease (CAD), accepting PCI&#xD;
        patients with stents or CABG, and willing to sign the subject consent and cooperate with&#xD;
        return.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Not eligible&#xD;
&#xD;
          2. Patients judged to be STEMI or NSTEMI by the physician&#xD;
&#xD;
          3. PCI bracket&#xD;
&#xD;
          4. Patients with severe skin damage near the electrode or sensor device.&#xD;
&#xD;
          5. Failure to cooperate in signing consent&#xD;
&#xD;
          6. Those who cannot be admitted to the hospital after the onset and have their first&#xD;
             examination before the operation&#xD;
&#xD;
          7. Unable to measure the ECG heart sounds. For example, if you use a heart rate&#xD;
             regulator, the ECG will show ventricular tachycardia (VT) and Dextrocardia on&#xD;
             admission.&#xD;
&#xD;
          8. Patients who are bedridden and have difficulty in cooperating with return visits&#xD;
&#xD;
          9. Any physician evaluation is not suitable for inclusion in the trial, and subjects who&#xD;
             are at high risk in the future cannot cooperate with the follow-up&#xD;
&#xD;
         10. Direct participants in this plan&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Ju-Chi Liu, MD</last_name>
    <role>Study Chair</role>
    <affiliation>Chief, Internal of Medicine</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Ju-Chi Liu, MD</last_name>
    <phone>886-2-22490088</phone>
    <phone_ext>8170</phone_ext>
    <email>liumdcv@tmu.edu.tw</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Yu-Ann FANG, MS</last_name>
    <phone>886-2-22490088</phone>
    <phone_ext>8891</phone_ext>
    <email>runawayyu@hotmail.com</email>
  </overall_contact_backup>
  <verification_date>June 2020</verification_date>
  <study_first_submitted>June 29, 2020</study_first_submitted>
  <study_first_submitted_qc>July 21, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 24, 2020</study_first_posted>
  <last_update_submitted>July 21, 2020</last_update_submitted>
  <last_update_submitted_qc>July 21, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">July 24, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Percutaneous Coronary Intervention</keyword>
  <keyword>Coronary Artery Bypass</keyword>
  <keyword>Phonocardiography, PPG</keyword>
  <keyword>Bracelet</keyword>
  <keyword>Vascular Restenosis</keyword>
  <keyword>Artificial intelligence</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Coronary Artery Disease</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT04485143
org study id: N202005037
nct id: NCT04485143
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Percutaneous coronary intervention (PCI) and coronary artery bypass graft (CABG) are the
      golden treatments for stable coronary artery disease (CAD) combined with heart failure (HF).
      The goal of treating HF patients is to prevent repeated hospitalizations and improve
      peri-operative survival; clinically, although routines including beta-receptor inhibitors,
      angiotensin-converting enzyme (ACE) inhibitors, and mineralocorticoids have been shown
      beneficial for the prognosis, for patients with severely low left ventricular ejection rate,
      hypotension, and pulmonary disease, the introduction of these drugs in the early
      postoperative period should still be cautious and may need to be adjusted with related
      cardiovascular function parameters. Patients with low cardiac output syndrome, ventricular
      arrhythmia, or hemodynamic instability should be suspected of the failure of bypass grafts if
      accompanied by changes in the electrocardiogram (EKG) and an increase in myocardial enzymes.
      Intervention should be carried out as soon as possible after angiography detects graft
      failure to limit the occurrence of large-scale myocardial injury and prevent the development
      of severe myocardial failure.

      This study is start on June 1 2020. And will include 400 patients who have just undergone PCI
      and 300 CABG patients who diagnosis of stable coronary artery disease. We will register their
      medical history, medications, and routine medical examinations within one year, and perform
      tests such as phonocardiography (Audiocor). They will be worn and measured daily at home
      after discharge. The data of the electrocardiogram and the PPG bracelet will be registered
      with their continuous daily values. All subjects tracked the occurrence of adverse medical
      events within one year after discharge from the hospital. Based on the home-based remote
      personal care model for patients with CABG, a risk prediction model for heart failure and
      vascular restenosis was established to effectively reduce medical treatment, adverse events,
      and medical expenditure.
This study is open, prospective study, multi-center, randomized controlled trial, unobtrusive
      research. This study is start on June 1 2020. And will include 400 patients who have just
      undergone PCI and 300 CABG patients who diagnosis of stable coronary artery disease. And
      random allocation 350 experimental group (Non-invasive Wearable Device) and 350 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 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.
observational model: Cohort
time perspective: Prospective
measure: death
time frame: Within a year
description: death, divided into yes or no
measure: Restenosis
time frame: Within a year
description: Come back to the hospital for PCI or CABG or MI (Judged by the physician) after discharge, divided into yes or no
measure: heart failure
time frame: Within a year
description: Come back to the hospital for heart failure (Judged by the physician) after discharge, divided into yes or no
measure: heart disease re-hospitalization
time frame: Within a year
description: Re-hospitalization for heart disease (Judged by the physician) after discharge, divided into yes or no
measure: Stroke re-hospitalization
time frame: Within a year
description: Re-hospitalization for Stroke (Judged by the physician) after discharge, divided into yes or no
measure: Arrhythmia re-hospitalization
time frame: Within a year
description: Re-hospitalization for Arrhythmia (Judged by the physician) after discharge, divided into yes or no
measure: Physician adjusts medicine
time frame: Within a year
description: According to the medicine order issued by the doctor, if there is any adjustment of the medicine, make a record,divided into yes or no
measure: Physician arranges examination early
time frame: Within a year
description: If the doctor has arranged to do Cardiac ultrasound or stress & redistribution myocardial perfusion scan with SPECT During non-table period, divided into yes or no
measure: Compliance
time frame: Within a year
description: 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 yes or no
measure: Medical cost
time frame: Within a year
description: The sum of all medical and health insurance expenses of the patient in the past year
arm group label: experimental group
description: Non-invasive Wearable Device
intervention type: Device
intervention name: Wisdom bracelet
description: routine medical
arm group label: experimental group
other name: control group (routine medical)
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 20 Years
maximum age: N/A
healthy volunteers: No
last name: Ju-Chi Liu, MD
role: Study Chair
affiliation: Chief, Internal of Medicine
last name: Ju-Chi Liu, MD
phone: 886-2-22490088
phone ext: 8170
email: liumdcv@tmu.edu.tw
last name: Yu-Ann FANG, MS
phone: 886-2-22490088
phone ext: 8891
email: runawayyu@hotmail.com
responsible party type: Sponsor
mesh term: Coronary Artery Disease
sharing ipd: Undecided