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
CRIS Registration Number |
KCT0003955 |
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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
Board Approval Status | Submitted approval |
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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 Person for Principal Investigator / Scientific Queries | |
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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
Study Site | Single | |
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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
1. Source of Monetary/Material Support | |
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Organization Name | Yonsei University Health System, Severance Hospital |
Organization Type | Medical Institute |
Project ID |
6. Sponsor Organization
1. Sponsor Organization | |
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Organization Name | Yonsei University Health System, Severance Hospital |
Organization Type | Medical Institute |
7. Study Summary
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. |
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8. Study Design
Study Type | Interventional Study |
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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
Condition(s)/Problem(s) |
* (I00-I99)Diseases of the circulatory system (I47.2)Ventricular tachycardia Refractory Ventricular Tachycardia |
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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)
Type of Primary Outcome | Efficacy | |
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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
Result Registered | No |
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12. Sharing of Study Data(Deidentified Individual-Patient Data, IPD)
Sharing Statement | Not provided at time of Registration |
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