UMIN-CTR Clinical Trial

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
Email	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
Email	norikom627@gmail.com

Sponsor
Institute	Kyorin University, School of Medicine
Institute
Department

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
Email

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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000020738