UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000017254 |
|---|---|
| Receipt number | R000020032 |
| Scientific Title | Tokyo CCU Network Home AED Program |
| Date of disclosure of the study information | 2015/04/23 |
| Last modified on | 2023/08/21 23:36:36 |
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Basic information
Public title
Tokyo CCU Network Home AED Program
Acronym
Home AED Program
Scientific Title
Tokyo CCU Network Home AED Program
Scientific Title:Acronym
Home AED Program
Region
| Japan |
Condition
Condition
Out-of-hospital cardiac arrest
Classification by specialty
| Cardiology | Emergency medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Clinical reserch
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Patient characteristics, outcomes
Key secondary outcomes
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
In-home AED
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
high risk for sudden death
Key exclusion criteria
implantatoin of implantable cardioverter defibrillator
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Morimasa |
| Middle name | |
| Last name | Takayama |
Organization
Tokyo Metropolitan Cardiovascular Care Unit Council
Division name
Secretariat
Zip code
151-0053
Address
2-5-4 Yoyogi Shibuya-ku Tokyo
TEL
03-6300-0317
yamamoto56@nms.ac.jp
Public contact
Name of contact person
| 1st name | Takeshi |
| Middle name | |
| Last name | Yamamoto |
Organization
Tokyo Metropolitan Cardiovascular Care Unit Council
Division name
Secretariat
Zip code
151-0053
Address
2-5-4 Yoyogi Shibuya-ku Tokyo
TEL
03-6300-0317
Homepage URL
yamamoto56@nms.ac.jp
Sponsor or person
Institute
Tokyo Metropolitan Cardiovascular Care Unit Council
Institute
Department
Personal name
Funding Source
Organization
Bureau of Social Welfare and Public Health, Tokyo Metropolitan Government
Organization
Division
Category of Funding Organization
Local Government
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Tokyo Metropolitan Cardiovascular Care Unit Council
Address
2-5-4 Yoyogi Shibuya-ku Tokyo
Tel
03-6300-0317
ccunet@nms.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
| 2015 | Year | 04 | Month | 23 | 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
30
Results
Results date posted
Results Delayed
| Delay expected |
Results Delay Reason
Final data compilation in progress
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
Main results already published
Date of protocol fixation
| 2008 | Year | 09 | Month | 30 | Day |
Date of IRB
| 2009 | Year | 01 | Month | 27 | Day |
Anticipated trial start date
| 2009 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2020 | Year | 03 | Month | 31 | 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 | 04 | Month | 23 | Day |
Last modified on
| 2023 | Year | 08 | Month | 21 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000020032
