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ECG monitoring with novel wireless machine in patients with cryptogenic Ischemic stroke

Status Approved

  • First Submitted Date

    2021/03/19

  • Registered Date

    2021/03/25

  • Last Updated Date

    2021/03/19

CRIS Required

WHO ICTRP (International Clinical Trial Registry Platform) Required

  • 1. Background

    Background - CRIS Registration Number, Unique Protocol ID, Public/Brief Title, Scientific Title, Acronym, MFDS Regulated Study, IND/IDE Protocol, Registered at Other Registry, Name of Registry/Registration Number
    CRIS
    Registration Number
    KCT0006027
    Unique Protocol ID SCHCA 2021-02-043
    Public/Brief Title ECG monitoring with novel wireless machine in patients with cryptogenic Ischemic stroke
    Scientific Title ECG monitoring with novel wireless machine in patients with cryptogenic Ischemic stroke
    Acronym
    MFDS Regulated Study No
    IND/IDE Protocol No
    Registered at Other Registry No
    Healthcare Benefit Approval Status Not applicable
  • 2. Institutional Review Board / Ethics Committee

    Institutional Review Board Information
    Board Approval Status Submitted approval
    Board Approval Number SCHCA 2021-02-043
    Approval Date 2021-03-05
    Institutional Review Board Name Soon Chun Hyang University Hospital Cheonan IRB
    Institutional Review Board Address 31, Suncheonhyang 6-gil, Dongnam-gu, Cheonan-si, Chungcheongnam-do
    Institutional Review Board Telephone 041-570-2985
    Data Monitoring Committee
  • 3. Contact Details

    Contact Details Information - Contact Person for Principal Investigator / Scientific Queries, Contact Person for Public Queries, Contact Person for Updating Information의 Name, Title, Email, Telephone, Cellular Phone, Affiliation, Address
    Contact Person for Principal Investigator / Scientific Queries
    Name Hyo-wook Gil
    Title Prof
    Telephone +82-41-570-3671
    Affiliation Soon Chun Hyang University Hospital Cheonan
    Address 31 Suncheonhyang 6-gil, Dongnam-gu, Cheonan-si, Chungcheongnam-do
    Contact Person for Public Queries
    Name Hanna Lee
    Title CRN
    Telephone +82-41-570-3677
    Affiliation Soon Chun Hyang University Hospital Cheonan
    Address 31 Suncheonhyang 6-gil, Dongnam-gu, Cheonan-si, Chungcheongnam-do
    Contact Person for Updating Information
    Name Hanna Lee
    Title CRN
    Telephone +82-41-570-3677
    Affiliation Soon Chun Hyang University Hospital Cheonan
    Address 31 Suncheonhyang 6-gil, Dongnam-gu, Cheonan-si, Chungcheongnam-do
  • 4. Status

    Status Information - Study Site, Overall Recruitment Status, Date of First Enrollment, Status of First Enrollment, Target Number of Participant, Primary Completion Date, Recruitment Status by Participating Study Site, Name of Study Site, Recruitment Status, Date of First Enrollment, Status of First Enrollemnt
    Study Site Single
    Overall Recruitment Status Not yet recruiting
    Date of First Enrollment 2021-04-01 Anticipated
    Target Number of Participant 87
    Primary Completion Date 2021-12-01 , Anticipated
    Study Completion Date 2021-12-01 , Anticipated
    Recruitment Status by Participating Study Site 1
    Name of Study Soon Chun Hyang University Hospital Cheonan
    Recruitment Status Not yet recruiting
    Date of First Enrollment 2021-04-01 ,
  • 5. Source of Monetary / Material Support

    Source of Monetary / Material Support Information - Organization Name, Organization Type, Project ID
    1. Source of Monetary/Material Support
    Organization Name National Research Foundation
    Organization Type Government
    Project ID 2019M3E5D1A02069073
  • 6. Sponsor Organization

    Sponsor Organization Information - Organization Name, Organization Type
    1. Sponsor Organization
    Organization Name Soon Chun Hyang University Hospital Cheonan
    Organization Type Medical Institute
  • 7. Study Summary

    Study Summary Information
    Lay Summary
    In about 20-40% of ischemic strokes, the exact cause has not been determined, which is defined as “cryptogenic stroke”. Atrial fibrillation(Af) is a major risk factor for ischemic stroke and at least 30% of patients with cryptogenic stroke have paroxysmal Af, but often remains undiagnosed in patients who have had an acute ischemic stroke. The detection of Af in patients with acute ischemic stroke is of major clinical relevance, because it usually shifts the secondary prevention therapy from antiplatelet drugs to oral anticoagulation. Oral anticoagulation therapy leads to a 60-70% relative risk reduction of recurrent strokes in those with Af, compared with placebo. However, due to the paroxysmal and asymptomatic nature of Af, Af might escape routine short-term electrocardiogram (ECG)-monitoring. Therefore, there are many strategies to improved the detection of Af, including in-hospital monitoring, serial electrocardiography and Holter monitoring, and the use of loop recorders or insertable cardiac monitors. In recent years, the wearable device (smart watch, pads...) for continuous ambulatory ECG recording have developed and expected to enhance the recognition ability of Af, but clinical experience with those products is limited. We therefore will investigate whether wireless ECG monitoring patch (which developed by Korean company Seerstech) is better for detection of Af than standard care procedures in patients with acute cryptogenic ischemic stroke.
  • 8. Study Design

    Study Design Information - Study Type, Observational Study Model, Time Perspective, Target Number of Participant, Cohort/Group Number, Cohort/Group, Cohort/Group Label, Cohort/Group Description, Biospecimen Collection & Archiving, Biospecimen Description
    Study Type Observational Study
    Observational Study Model Cohort
    Time Perspective Prospective  
    Target Number of Participant 87
    Cohort/Group Number 1
    Cohort/
    Group 1

    Cohort/Group Label

    Cryptogenic ischemic stroke patients with wireless ECG monitoring patch

    Cohort/Group Description

    Cryptogenic inschemic stroke patients are observed in a cohort. Atrial fibrillation detection rates are observed in patients with wireless ECG monitoring patches in cryotogeni ischemic stroke patients.
    Biospecimen
    Collection & Archiving
    Not collect nor Archive
    Biospecimen Description
  • 9. Subject Eligibility

    Subject Eligibility Information
    Study Population Description
    Patients aged 19 or older who have been hospitalized with cryotogenic ischemic stroke at Soonhunhyang University Cheonan Hospital within seven days.
    Sampling Method
    The sample size estimation is based findings of the previous trial Find-AF (Lancet Neurol 2017; 16: 282-290).
    Condition(s)/Problem(s) * (I00-I99)Diseases of the circulatory system 
       (I62.9)Intracranial haemorrhage(nontraumatic), unspecified 

    Cryptogenic Ischemic Stroke
    Rare Disease No
    Inclusion Criteria

    Gender

    Both

    Age

    19Year~No Limit

    Description

    1. Patients who have been hospitalized with cryotogenic ischemic stroke at Soonhunhyang University Cheonan Hospital (clinical symptom onset < 7days)
    2. Patients who agree to participate in this study
    3. Age ; 19 years or older
    Exclusion Criteria
    1. Patients with known or documented atrial fibrillation.
    2. Patients with ipsilateral carotid stenosis (>50% according to the North American Symptomatic Carotid Endarterectomy Trial [NASCET] classification)
    3. Patients with clinically significant vertebral artery stenosis of more than 50%, and those with acute arterial dissections.
    4. Patients with a pacemaker inserted
    5. Children
    6. Pregnant women
    7. Patients with allergic reactions to patches.
    Healthy Volunteers No
  • 10. Outcome Measure(s)

    Outcome Measure(s) Information - Type of Primary Outcome, Primary Outcome, Outcome, Timepoint, Secondary Outcome, Outcome, Timepoint
    Type of Primary Outcome Efficacy
    Primary Outcome(s) 1
    Outcome
    The detection rate of atrial fibrillation
    Timepoint
    After removing the wireless ECG monitoring patch at the time of discharge
    Secondary Outcome(s) 1
    Outcome
    The detection rate of other arrhythmia except atrial fibrillation
    Timepoint
    After removing the wireless ECG monitoring patch at the time of discharge
  • 11. Study Results and Publication

    Study Results and Publication Information - Result Registered, Final Enrollment Number, Number of Publication, Publications, Results Upload, Date of Posting Results, Protocol URL or File Upload, Brief Summary
    Result Registered No
  • 12. Sharing of Study Data(Deidentified Individual-Patient Data, IPD)

    Sharing of Study Data Information - Sharing Statement, Time of Sharing, Way of Sharing
    Sharing Statement No
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