UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000024608 |
|---|---|
| Receipt number | R000028314 |
| Scientific Title | Validation of efficiency of transdermal patch beta1 blocker on Coronary Computed Tomography Angiography |
| Date of disclosure of the study information | 2016/10/30 |
| Last modified on | 2019/09/15 07:01:18 |
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Basic information
Public title
Validation of efficiency of transdermal patch beta1 blocker on Coronary Computed Tomography Angiography
Acronym
Validation of efficiency of transdermal patch beta1 blocker on Coronary Computed Tomography Angiography
Scientific Title
Validation of efficiency of transdermal patch beta1 blocker on Coronary Computed Tomography Angiography
Scientific Title:Acronym
Validation of efficiency of transdermal patch beta1 blocker on Coronary Computed Tomography Angiography
Region
| Japan |
Condition
Condition
Ischemic heart desese
Classification by specialty
| Medicine in general | Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Efficacy of beta1 blocker patch to reduce heart rate on coronary CT
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Reduction of heart rate at office and on coronary CT
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Factorial
Randomization
Randomized
Randomization unit
Cluster
Blinding
Open -no one is blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Diagnosis
Type of intervention
| Medicine |
Interventions/Control_1
bisono tape 4mg/notreatment
Interventions/Control_2
8hour before
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
| 35 | years-old | <= |
Age-upper limit
| 100 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Suspicious ischemic heart desese patients
Key exclusion criteria
Afib
Target sample size
80
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Arai Junji |
Organization
Sizuoka red cross Hospital
Division name
Cardiovascular department
Zip code
Address
420-0853 Sizuoka-city Aoi otte-cho 8-2
TEL
054-254-4311
junjiar@gmal.com
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Arai Junji |
Organization
Sizuoka red cross Hospital
Division name
Cardiovascular department
Zip code
Address
420-0853 Sizuoka-city Aoi otte-cho 8-2
TEL
054-254-4311
Homepage URL
junjiar@gmal.com
Sponsor or person
Institute
Sizuoka red cross Hospital Cardiovascular departent
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
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
| 2016 | Year | 10 | Month | 30 | 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
Enrolling by invitation
Date of protocol fixation
| 2015 | Year | 01 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2016 | Year | 11 | Month | 01 | Day |
Last follow-up date
| 2017 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
| 2017 | Year | 12 | Month | 31 | Day |
Date trial data considered complete
| 2017 | Year | 12 | Month | 31 | Day |
Date analysis concluded
| 2018 | Year | 03 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2016 | Year | 10 | Month | 28 | Day |
Last modified on
| 2019 | Year | 09 | Month | 15 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028314
