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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000035246
Receipt No. R000040160
Scientific Title Efficiency evaluation of coronary computed tomography by using transdermal patch beta-blocker (high rate)
Date of disclosure of the study information 2018/12/13
Last modified on 2019/07/03

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Basic information
Public title Efficiency evaluation of coronary computed tomography by using transdermal patch beta-blocker (high rate)
Acronym Efficiency evaluation of coronary computed tomography by using transdermal patch beta-blocker (high rate)
Scientific Title Efficiency evaluation of coronary computed tomography by using transdermal patch beta-blocker (high rate)
Scientific Title:Acronym Efficiency evaluation of coronary computed tomography by using transdermal patch beta-blocker (high rate)
Region
Japan

Condition
Condition Ischemic heart disease
Classification by specialty
Medicine in general
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Efficiency of heart rate reduction by using transdermal patch beta-blocker on coronary computed tomography
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Time until taking an image on coronary computed tomography
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -no one is blinded
Control No treatment
Stratification NO
Dynamic allocation
Institution consideration Institution is not considered as adjustment factor.
Blocking YES
Concealment Central registration

Intervention
No. of arms 2
Purpose of intervention Diagnosis
Type of intervention
Medicine
Interventions/Control_1 bisoprolol tape 8mg
Interventions/Control_2 none
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
100 years-old >
Gender Male and Female
Key inclusion criteria Suspicious ischemic heart disease patients
Key exclusion criteria asthma
chronic kidney disease stage 4.5
Target sample size 60

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Yamazaki Daisuke
Organization Tokyo heart center
Division name Cardiovascular department
Zip code
Address 5-4-12 Kita-shinagawa,Shinagawa Tokyo 141-0001, Japan
TEL 0357898100
Email circulation_777@yahoo.co.jp

Public contact
Name of contact person
1st name
Middle name
Last name Yamazaki Daisuke
Organization Tokyo heart center
Division name Cardiovascular department
Zip code
Address 5-4-12 Kita-shinagawa,Shinagawa Tokyo 141-0001, Japan
TEL 0357898100
Homepage URL
Email circulation_777@yahoo.co.jp

Sponsor
Institute Saitama memorial hospital
Institute
Department

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
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
2018 Year 12 Month 13 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 Open public recruiting
Date of protocol fixation
2018 Year 12 Month 13 Day
Date of IRB
2018 Year 12 Month 13 Day
Anticipated trial start date
2018 Year 12 Month 13 Day
Last follow-up date
2019 Year 07 Month 02 Day
Date of closure to data entry
Date trial data considered complete
2019 Year 07 Month 02 Day
Date analysis concluded

Other
Other related information

Management information
Registered date
2018 Year 12 Month 13 Day
Last modified on
2019 Year 07 Month 03 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040160

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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