UMIN-CTR Clinical Trial

Basic information
Public title	Evaluation of myocardial sympathetic activity and myocardial blood flow assessed by the C-11 hydroxyephedrine and O-15 water PET/CT in patients who underwent implantable cardioverter-defibrillator for the treatment of ventricular arrhythmia.
Acronym	Evaluation of myocardial sympathetic activity and blood flow for the patients with ventricular arrhythmia.
Scientific Title	Evaluation of myocardial sympathetic activity and myocardial blood flow assessed by the C-11 hydroxyephedrine and O-15 water PET/CT in patients who underwent implantable cardioverter-defibrillator for the treatment of ventricular arrhythmia.
Scientific Title:Acronym	Evaluation of myocardial sympathetic activity and blood flow for the patients with ventricular arrhythmia.
Region	Japan

Condition
Condition	ventricular arrhythmia
Classification by specialty	Cardiology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To clarify the effect of myocardial sympathetic activity on ICD discharge.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2	Pragmatic
Developmental phase	Not applicable

Assessment
Primary outcomes	The changes of myocardial sympathetic activity in patients with ventricular arrhythmia after ICD implantation.
Key secondary outcomes	The effect for ICD discharge or sudden cardiac death by changes of regional myocardial sympathetic activity.

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	Prevention
Type of intervention	Medicine
Interventions/Control_1	C11-hydroxyephedrine 185MBq, intravenous infusion at PET/CT scan O15-water 500MBq, intravenous infusion at PET/CT scan
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	20 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	We will include patients with ventricular arrhythmia who regularly come to Department of Cardiology at Hokkaido University Hospital, and who satisfy all criteria as shown below. 1) Patients who is more than 20 years old at registration. 2) Patients with severe ventricular arrhythmia who need either ICD or CRTD according to the guideline of Japanese Circulation Society. 3) Patients who consented this study under enough understanding after sufficient explanation from us.
Key exclusion criteria	We will exclude the patients who satisfy any criteria as shown below. 1) Patients do not agree with the study protocol. 2) Patients who are expected to die within a year. 3) Patients who will be scheduled cardiac surgery or who underwent cardiac surgery within 3 months. 4) Patients who are expected to be difficult to follow up. 5) Patients whom we judge as inappropriate for this study.
Target sample size	30

Research contact person
Name of lead principal investigator	1st name Tsutsui Middle name Last name Hiroyuki
Organization	Hokkaido University Hospital
Division name	Department of Cardiology
Zip code	060-8638
Address	N-15, W-7, Kita-ku, Sapporo, Hokkaido
TEL	011-716-1161
Email	htsutsui@med.hokudai.ac.jp

Public contact
Name of contact person	1st name Naya Middle name Last name Masanao
Organization	Hokkaido University Hospital
Division name	Department of Cardiology
Zip code	060-8638
Address	N-15, W-7, Kita-ku, Sapporo, Hokkaido
TEL	011-716-1161
Homepage URL
Email	naya@med.hokudai.ac.jp

Sponsor
Institute	Hokkaido University Hospital, Department of Cardiology
Institute
Department

Funding Source
Organization	None
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization	Hokkaido Universtiy
Address	north 14, west 5, Sapporo
Tel	011-701-7636
Email	crjimu@huhp.hokudai.ac.jp

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

Other administrative information
Date of disclosure of the study information	2014 Year 01 Month 11 Day

Related information
URL releasing protocol	None
Publication of results	Unpublished

Result
URL related to results and publications	None
Number of participants that the trial has enrolled	0
Results	NA
Results date posted	2020 Year 01 Month 16 Day
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics	NA
Participant flow	NA
Adverse events	NA
Outcome measures	NA
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status	Completed
Date of protocol fixation	2013 Year 12 Month 12 Day
Date of IRB	2013 Year 12 Month 24 Day
Anticipated trial start date	2013 Year 01 Month 11 Day
Last follow-up date	2017 Year 03 Month 31 Day
Date of closure to data entry	2017 Year 03 Month 31 Day
Date trial data considered complete
Date analysis concluded

Other
Other related information	none

Management information
Registered date	2014 Year 01 Month 11 Day
Last modified on	2020 Year 01 Month 16 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000014983