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Recruitment status
Unique ID issued by UMIN UMIN000012824
Receipt No. R000014983
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.
Date of disclosure of the study information 2014/01/11
Last modified on 2017/01/18

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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
Middle name
Last name Hiroyuki Tsutsui
Organization Hokkaido University Hospital
Division name Department of Cardiology
Zip code
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
Middle name
Last name Masanao Naya
Organization Hokkaido University Hospital
Division name Department of Cardiology
Zip code
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
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

Other administrative information
Date of disclosure of the study information
2014 Year 01 Month 11 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
Date of protocol fixation
2013 Year 12 Month 12 Day
Date of IRB
Anticipated trial start date
2014 Year 01 Month 11 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2014 Year 01 Month 11 Day
Last modified on
2017 Year 01 Month 18 Day


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

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
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