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Prospective randomized clinical trial for effect of stellate ganglion block in medically refractory ventricular tachycardia

Status Approved

  • First Submitted Date

    2018/06/14

  • Registered Date

    2019/05/21

  • Last Updated Date

    2019/05/20

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
    KCT0003955
    Unique Protocol ID 4-2015-0743
    Public/Brief Title Prospective randomized clinical trial for effect of stellate ganglion block in medically refractory ventricular tachycardia
    Scientific Title Prospective randomized clinical trial for effect of stellate ganglion block in medically refractory ventricular tachycardia
    Acronym
    MFDS Regulated Study No
    IND/IDE Protocol
    Registered at Other Registry No
    Healthcare Benefit Approval Status Submitted pending
  • 2. Institutional Review Board / Ethics Committee

    Institutional Review Board Information
    Board Approval Status Submitted approval
    Board Approval Number 4-2015-0743
    Approval Date 2015-09-22
    Institutional Review Board Name Yonsei University Health System, Severance Hospital, Institutional Review Board
    Institutional Review Board Address 50-1, Yonsei-ro, Seodaemun-gu, Seoul
    Institutional Review Board Telephone 02-2228-0435
    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 huinam Pak
    Title professor
    Telephone +82-2-2228-8459
    Affiliation Yonsei University Health System, Severance Hospital
    Address 50-1, Yonsei-ro, Seodaemun-gu, Seoul
    Contact Person for Public Queries
    Name sohee Joo
    Title CRC
    Telephone +82-2-2228-8528
    Affiliation Yonsei University Health System, Severance Hospital
    Address 50-1, Yonsei-ro, Seodaemun-gu, Seoul
    Contact Person for Updating Information
    Name sohee Joo
    Title CRC
    Telephone +82-2-2228-8528
    Affiliation Yonsei University Health System, Severance Hospital
    Address 50-1, Yonsei-ro, Seodaemun-gu, Seoul
  • 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 2019-06-14 Anticipated
    Target Number of Participant 20
    Primary Completion Date
    Study Completion Date
    Recruitment Status by Participating Study Site 1
    Name of Study Yonsei University Health System, Severance Hospital
    Recruitment Status Not yet recruiting
    Date of First Enrollment 2019-06-14 ,
  • 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 Yonsei University Health System, Severance Hospital
    Organization Type Medical Institute
    Project ID
  • 6. Sponsor Organization

    Sponsor Organization Information - Organization Name, Organization Type
    1. Sponsor Organization
    Organization Name Yonsei University Health System, Severance Hospital
    Organization Type Medical Institute
  • 7. Study Summary

    Study Summary Information
    Lay Summary
    The investigators will compare the effects of PSGB(percutaneous stellate ganglion block) in patients with recurrent sustained VT(ventricular tachycardia)/VF(ventricular flutter) in spite of appropriate medical therapy and cardio-version/ defibrillation after correction of underlying correctable factors with those without PSGB by prospective randomized trail. PSGB(percutaneous stellate ganglion block) will be performed every 3 days by anesthesiology specialist after cardiologist's request, until the stabilization of VT(ventricular tachycardia)/VF(ventricular flutter). We will compare the frequency and episode number of VT(ventricular tachycardia)/VF(ventricular flutter), procedure related complication, acute and long-term mortality.
  • 8. Study Design

    Study Design Information - Study Type, Study Purpose, Phase, Intervention Model, Blinding/Masking, Blinded Subject, Allocation, Intervention Type, Intervention Description, Number of Arms, Arm Label, Target Number of Participant, Arm Type, Arm Description
    Study Type Interventional Study
    Study Purpose
    Treatment
    Phase Not applicable
    Intervention Model Parallel  
    Blinding/Masking Open
    Allocation RCT
    Intervention Type /Procedure/Surgery  
    Intervention Description
    1. Research registration for medically refractory ventricular tachycardia
    2. Treatment of Antiarrhythmic drug in both the experimental group and the control group
    3. In addition, the experimental group implements percutaneous stellate ganglion block.
    
    < Study Arms >
    •Experimental : Antiarrhythmic drug + percutaneous stellate ganglion block
    •Active Comparator : Antiarrhythmic drug group
    
    4. Treat according to assigned group
    5. Additional treatments are performed three days after the implementation of the percutaneous stellate ganglion block.
    6. Continuous ECG monitoring and ICD interrogation during post-procedure hospitalization
     - Evaluation of the frequency of continuous ventricle tachycardia and ICD shock + anti-tachycardia pacing (ICD-insert patient) after treatment begins
    7. Evaluation of the frequency of death and persistence of tachycardia and ICD shock + anti-tachycardia pacing (ICD-insert patient) in each group thereafter
    8. Outpatient tracking after discharge
     - Assess all side effects that occur in each group
    Number of Arms 2
    Arm 1

    Arm Label

    (Antiarrhythmic drug + percutaneous stellate ganglion block) group

    Target Number of Participant

    10

    Arm Type

    Experimental

    Arm Description

    ◦Drug: Antiarrhythmic drug
    ◦Procedure: percutaneous stellate ganglion block (PSGB)
     - The subjects of this study were in a highly unstable blood flow condition and therefore difficult to move to the treatment room, making it the most likely to be conducted a method of the percutaneous stellate ganglion block for ultrasonography in bedside under these clinical circumstances.
    The percutaneous stellate ganglion block is performed in the cardiac intensive care unit where can monitor blood pressure, pulse, oxygen saturation, body temperature, and electrocardiogram on experienced and skilled anesthesia pain medicine specialists.
    Arm 2

    Arm Label

    Antiarrhythmic drug group

    Target Number of Participant

    10

    Arm Type

    Active comparator

    Arm Description

    It's a drug treatment group that takes antichromatic drugs.
  • 9. Subject Eligibility

    Subject Eligibility Information
    Condition(s)/Problem(s) * (I00-I99)Diseases of the circulatory system 
       (I47.2)Ventricular tachycardia  

    Refractory Ventricular Tachycardia
    Rare Disease No
    Inclusion Criteria

    Gender

    Both

    Age

    20Year~85Year

    Description

    1. Over 19 years old or The legal age at which consent for the target can be provided under national law.
    2. Patient are diagnosed Refractory Ventricular tachycardia
     - Patients who have generated Refractory Ventricular tachycardia despite of defibrillation and drug therapy
     - Patients with ICD have generated ICD shock or anti-tachycardia pacing despite of defibrillation and drug therapy
    Exclusion Criteria
    1. Patients who do not agree with study inclusion
    2. Patients who do not taken stellate ganglion block due to unstable hemodynamic status
    3. Patients have experienced major hemorrhagic complication
    4. Patients of the DNR(do not resuscitate) status
    5. Patients with malignancy tumor, major neurogenic disease or gastrointestinal disease
    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
    Comparison of frequency changes in persistent ventricular fibrillation that occurred 24 hours before and after treatment began in each group.
    Timepoint
    24 hours before and after treatment begins
    Primary Outcome(s) 2
    Outcome
    Comparison of Frequency Changes in persistent ventricular fibrillation in 5 Days  in each group
    Timepoint
    5 days after randomization
    Secondary Outcome(s) 1
    Outcome
    mortality
    Timepoint
    on discharge, 1 month and 1 year after the discharge,
    Secondary Outcome(s) 2
    Outcome
    For ICD(implantable cardioverter defibrillator) patients, anti - tachycardia + shock occurrence and frequency
    Timepoint
    at every visit after treatment
    Secondary Outcome(s) 3
    Outcome
    major complication related to stellate ganglion block.
    Timepoint
    after treatment
  • 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 Not provided at time of Registration
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