UMIN-CTR Clinical Trial

Basic information
Public title	Conparision of transdermal patch beta1 blocker or oral medication on Coronary Computed Tomography Angiography
Acronym	Conparision of transdermal patch beta1 blocker or oral medication on Coronary Computed Tomography Angiography
Scientific Title	Conparision of transdermal patch beta1 blocker or oral medication on Coronary Computed Tomography Angiography
Scientific Title:Acronym	Conparision of transdermal patch beta1 blocker or oral medication 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	Conparision of beta1 blocker patch and oral medication to reduce heart rate on coronary CT
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Exploratory
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	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Open -no one is blinded
Control	Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	bisono tape 4mg/
Interventions/Control_2	Metoprolol
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	85 years-old >
Gender	Male and Female
Key inclusion criteria	Suspicious ischemic heart desese patients
Key exclusion criteria	Afib
Target sample size	100

Research contact person
Name of lead principal investigator	1st name arai Middle name Last name junji
Organization	Kansai Medical Hospital
Division name	Depertment of Cardiology
Zip code	560-0083
Address	1-1-7-2 Shinsenrinishimachi,Toyonaka,Osaka
TEL	06-6836-1199
Email	junjiar@gmail.com

Public contact
Name of contact person	1st name arai Middle name Last name junji
Organization	Kansai Medical Hospital
Division name	Depertment of Cardiology
Zip code	560-0083
Address	1-1-7-2 Shinsenrinishimachi,Toyonaka,Osaka
TEL	06-6836-1199
Homepage URL
Email	junjiar@gmail.com

Sponsor
Institute	Kansai Medical Hospital
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	Kansai Medical Hospital
Address	1-1-7-2 Shinsenrinishimachi,Toyonaka,Osaka
Tel	06-6836-1199
Email	junjiar@gmail.com

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	2020 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	Preinitiation
Date of protocol fixation	2020 Year 01 Month 01 Day
Date of IRB
Anticipated trial start date	2020 Year 01 Month 11 Day
Last follow-up date	2020 Year 12 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	2020 Year 01 Month 11 Day
Last modified on	2020 Year 01 Month 11 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000044624