UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000017961 |
|---|---|
| Receipt number | R000020738 |
| Scientific Title | Non-invasive Neuromodulation for Ventricular Electrical Etorm: RESCUE VT |
| Date of disclosure of the study information | 2015/06/18 |
| Last modified on | 2019/06/22 10:20:17 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Non-invasive Neuromodulation for Ventricular Electrical Etorm: RESCUE VT
Acronym
RESCUE VT
Scientific Title
Non-invasive Neuromodulation for Ventricular Electrical Etorm: RESCUE VT
Scientific Title:Acronym
RESCUE VT
Region
| Japan |
Condition
Condition
Ventricular tachycardia/ventricular fibrillation
Classification by specialty
| Cardiology | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
In healthy subject:
To evaluate the effect of stellate ganglion phototherapy on autonomic nervous system.
In patients with ventricular arrhythmia:
To clarify that stellate ganglion phototherapy suppresses ventricular arrhythmia in patients with ventricular arrhythmias.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Healthy population; Heart rate, QT, QTc in 12 lead ECG
Total heart beats, maximum/minimum/average heart rate, maximum RR interval, LF, HF, LF/HF in
ambulatory ECG
catecholamine concentration, WBC count
Patients; in addition to the parameters as healthy population, number of ventricular arrhythmia episodes
Key secondary outcomes
Patients: survival rate of 2 years, number of ventricular arrhythmia episodes, recurrence of ventricular arrhythmia
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
Linear Polarized Near lnfrared Ray lrradiation or Xenon Phototherapy
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Healthy population:
One with normal 12 lead ECG and without any previous medical history.
Patients:
1) Without ICD; patients with drug refractory VA and in a condition of electrical storm. Patients with VA and he/she could not undergo catheter ablation due to poor general status, or patients with VA in whom CA was not effective.
2) With ICD; patients with frequent ICD therapies for VA and he/she could not undergo CA or CA was not effective.
Key exclusion criteria
When the patient or his/her family does not agree with the enrollment
Target sample size
70
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Kyoko Soejima |
Organization
Kyorin University, School of Medicine
Division name
Second Department of Internal Medicine
Zip code
Address
Shinkawa 6-20-2 Mitaka-shi, Tokyo, JAPAN
TEL
0422-47-5511
norikom627@gmail.com
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Noriko Matsushita |
Organization
Kyorin University Hospital
Division name
Cardiology
Zip code
Address
Shinkawa 6-20-2 Mitaka-shi, Tokyo, JAPAN
TEL
0422-47-5511
Homepage URL
norikom627@gmail.com
Sponsor or person
Institute
Kyorin University, School of Medicine
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
University of Tsukuba Hospital, Yokohama Rosai Hospital, Sanin Rosai Hospital, Kanazawa Medical Center, Toyota Kosei Hospital
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
杏林大学医学部 (東京都)
Other administrative information
Date of disclosure of the study information
| 2015 | Year | 06 | Month | 18 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2015 | Year | 06 | Month | 01 | Day |
Date of IRB
| 2015 | Year | 06 | Month | 01 | Day |
Anticipated trial start date
| 2015 | Year | 06 | Month | 18 | Day |
Last follow-up date
| 2019 | Year | 03 | Month | 18 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2015 | Year | 06 | Month | 18 | Day |
Last modified on
| 2019 | Year | 06 | Month | 22 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000020738
