UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000012824 |
|---|---|
| Receipt number | 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 | 2020/01/16 11:04:13 |
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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 | 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
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
naya@med.hokudai.ac.jp
Sponsor or person
Institute
Hokkaido University Hospital, Department of Cardiology
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
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Hokkaido Universtiy
Address
north 14, west 5, Sapporo
Tel
011-701-7636
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000014983
