<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/NCT04455568</url>
  </required_header>
  <id_info>
    <org_study_id>N202004123</org_study_id>
    <nct_id>NCT04455568</nct_id>
  </id_info>
  <brief_title>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.</brief_title>
  <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.</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>Taipei Medical University</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>
      Heart disease is still one of the world's most important health problems, and it ranks second&#xD;
      among the top ten causes of death among Taiwan. The main cause of death is acute coronary&#xD;
      syndrome, and vascular stent placement is the main treatment method for acute coronary&#xD;
      syndrome. The probability of restenosis in patients within half a year after a general stent&#xD;
      is as high as 25% to 40%. Re-hospitalization and surgery is a big burden on patients and the&#xD;
      country's medical costs. However, a set of convenient and accurate clinical tools to&#xD;
      determine the prognosis of patients has not yet been developed. Miniaturized wearable devices&#xD;
      have been the mainstream trend in medical development in recent years. ECG and heart sound&#xD;
      analysis technology are an easy to used medical device for automatically calculating the&#xD;
      parameters including EMAT (electromechanical activation time), S4, S4, SDI (Systolic&#xD;
      dyssynchrony index). ECG and heart sound could evaluate the heart function, and has the&#xD;
      potential to be an effective tools for prognosis and treatment guidelines. Heart rate&#xD;
      variability (HRV) and Accelerationplethysmogram (APG) is also proved the predictive effect&#xD;
      the outcome of patients.&#xD;
&#xD;
      This study is start on June 1 2020. We will enroll 400 patients who diagnosis of acute&#xD;
      coronary syndrome and have been a heart stent surgery, and registry there medical&#xD;
      history,routine examination and medication, ECG and heart, HRV and APG record at admission,&#xD;
      pre-discharge and every routine return visit within I year after discharge.Patients will also&#xD;
      wear ECG and PPG (Photoplethysmography) band ever day after discharge, and collected the&#xD;
      longitutinal data .All subjects will be tracked the medical adverse events in 1 years after&#xD;
      discharge, and compare the characteristic and prognosis value of between patients with and&#xD;
      without events. Therefore, our purpose of this study is to drive an effective outcome&#xD;
      prediction model by non-invasive device, and establish a telecare model of patient with heart&#xD;
      stent implantation to reducing medical adverse events.&#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. We will enroll 400 patients who diagnosis of&#xD;
      acute coronary syndrome and have been a heart stent surgery. And random allocation 200&#xD;
      experimental group (Non-invasive Wearable Device) and 200 control group (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 (case report form) only&#xD;
      displays the study number, and no subject is available. In addition to the examination of&#xD;
      each return visit, the subjects also took the ECG bracelet home at the time of discharge (V0)&#xD;
      and wore it every day. After the discharge, the ECG was measured every morning and evening,&#xD;
      and their personal activity and sleep were collected. Relevant information. After the subject&#xD;
      was discharged from the hospital, the subject tracked the date of all adverse events due to&#xD;
      cardiovascular disease within one year, including: heart failure, restenosis due to blood&#xD;
      vessel, and non-fatal myocardial infarction , To do blood vessel-related surgery again, and&#xD;
      data on the 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>Other</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</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Restenosis</measure>
    <time_frame>Within a year</time_frame>
    <description>Restenosis</description>
  </primary_outcome>
  <primary_outcome>
    <measure>heart failure</measure>
    <time_frame>Within a year</time_frame>
    <description>heart failure</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>heart disease re-hospitalization</measure>
    <time_frame>Within a year</time_frame>
    <description>heart disease re-hospitalization</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Stroke re-hospitalization</measure>
    <time_frame>Within a year</time_frame>
    <description>Stroke re-hospitalization</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Arrhythmia re-hospitalization</measure>
    <time_frame>Within a year</time_frame>
    <description>Arrhythmia re-hospitalization</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Physician adjusts medicine</measure>
    <time_frame>Within a year</time_frame>
    <description>Physician adjusts medicine</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Physician arranges examination early</measure>
    <time_frame>Within a year</time_frame>
    <description>Physician arranges examination early</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Medical 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 presence and absence</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Medical Costs</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">400</enrollment>
  <condition>Acute Coronary Syndrome</condition>
  <condition>Percutaneous Transluminal Coronary Angioplasty</condition>
  <arm_group>
    <arm_group_label>experimental group</arm_group_label>
    <description>Non-invasive Wearable Device, use ECG Wisdom bracelet</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>use EKG Wisdom bracelet</intervention_name>
    <description>Non-invasive Wearable Device (use EKG Wisdom bracelet)</description>
    <arm_group_label>experimental group</arm_group_label>
    <other_name>control group (routine medical)</other_name>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        We will enroll 400 patients who diagnosis of acute coronary syndrome and have been a heart&#xD;
        stent surgery. And random allocation 200 experimental group (Non-invasive Wearable Device)&#xD;
        and 200 control group (routine medical).&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. ≥ 20-year-old&#xD;
&#xD;
          2. Patients performing general metal stent surgery&#xD;
&#xD;
          3. Diagnosis of Acute Coronary Syndrome&#xD;
&#xD;
          4. Willing to sign the consent form of the subject and cooperate with the return visit&#xD;
&#xD;
          5. Those who are admitted to the hospital and enter the general ward can receive the&#xD;
             first ECG heart sound examination&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. &lt;20-year-old&#xD;
&#xD;
          2. Before the stent was installed, the same blood vessel had been used in patients with&#xD;
             PCI (percutaneous coronary intervention) and CABG (Coronary artery bypass graft).&#xD;
&#xD;
          3. Those who cannot perform the first examination after being admitted to the hospital&#xD;
             and entering the general ward&#xD;
&#xD;
          4. It is impossible to measure the group of ECG and heart sounds. For example, when using&#xD;
             Pacemaker, the ECG showed ventricular tachycardia (VT) and Dextrocardia on admission.&#xD;
&#xD;
          5. Patients who are bedridden and have difficulty in cooperating with return visits&#xD;
&#xD;
          6. Any subject that the physician believes is at high risk for future uncooperative&#xD;
             tracking&#xD;
&#xD;
          7. Direct participants in this program&#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>Principal Investigator</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 28, 2020</study_first_submitted>
  <study_first_submitted_qc>June 28, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 2, 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 23, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Artificial Intelligence</keyword>
  <keyword>Non-invasive Wearable Device</keyword>
  <keyword>Telecare Model of Patient,</keyword>
  <keyword>Acute Coronary Syndrome</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Acute Coronary Syndrome</mesh_term>
    <mesh_term>Syndrome</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/NCT04455568
org study id: N202004123
nct id: NCT04455568
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
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.
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.
observational model: Other
time perspective: Prospective
measure: death
time frame: Within a year
description: death
measure: Restenosis
time frame: Within a year
description: Restenosis
measure: heart failure
time frame: Within a year
description: heart failure
measure: heart disease re-hospitalization
time frame: Within a year
description: heart disease re-hospitalization
measure: Stroke re-hospitalization
time frame: Within a year
description: Stroke re-hospitalization
measure: Arrhythmia re-hospitalization
time frame: Within a year
description: Arrhythmia re-hospitalization
measure: Physician adjusts medicine
time frame: Within a year
description: Physician adjusts medicine
measure: Physician arranges examination early
time frame: Within a year
description: Physician arranges examination early
measure: Medical 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 presence and absence
measure: Medical Costs
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, use ECG Wisdom bracelet
intervention type: Device
intervention name: use EKG Wisdom bracelet
description: Non-invasive Wearable Device (use EKG Wisdom bracelet)
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: Principal Investigator
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: Acute Coronary Syndrome
mesh term: Syndrome
sharing ipd: Undecided