UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000035246 |
|---|---|
| Receipt number | 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 | 2023/06/26 18:52:58 |
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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 | Daisuke |
| Middle name | |
| Last name | Yamazaki |
Organization
Tokyo heart center
Division name
Cardiovascular department
Zip code
1410001
Address
5-4-12 Kita-shinagawa,Shinagawa Tokyo 141-0001, Japan
TEL
0357898100
circulation_777@yahoo.co.jp
Public contact
Name of contact person
| 1st name | Daisuke |
| Middle name | |
| Last name | Yamazaki |
Organization
Tokyo heart center
Division name
Cardiovascular department
Zip code
1410001
Address
5-4-12 Kita-shinagawa,Shinagawa Tokyo 141-0001, Japan
TEL
0357898100
Homepage URL
circulation_777@yahoo.co.jp
Sponsor or person
Institute
Saitama memorial hospital
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
Saitama memorial hospital
Address
a
Tel
048-686-3111
yamazaki@tokyoheart.or.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
| 2018 | Year | 12 | Month | 13 | Day |
Related information
URL releasing protocol
https://www.clinicalkey.jp/service/content/pdf/watermarked/1-s2.0-S091450871930303X.pdf?locale=ja_JP
Publication of results
Partially published
Result
URL related to results and publications
https://www.clinicalkey.jp/service/content/pdf/watermarked/1-s2.0-S091450871930303X.pdf?locale=ja_JP
Number of participants that the trial has enrolled
63
Results
Baseline characteristics did not significantly differ between two groups. HR was significantly
lower upon arrival at the CCTA suite in Bis, than standard protocol group (67.5 +- 7.8 bpm vs.
75.0 +- 10.6 bpm; p = 0.00002), and the amount of elapsed time from arrival to the start of CCTA
evaluation was also significantly decreased in Bis group (76.9 +- 34.9 min vs. 94.8 +- 29.2 min; p = 0.0356).
Results date posted
| 2023 | Year | 06 | Month | 26 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
| 2019 | Year | 10 | Month | 16 | Day |
Baseline Characteristics
63 patients with an HR of >70 bpm and systolic blood pressure >120
mmHg
Participant flow
We randomly assigned 63 patients with an HR of >70 bpm and systolic blood pressure >120
mmHg to a standard protocol group (n = 33) or a group (n = 30) that applied a bisoprolol 8 mg
transdermal patch (Bis) at bedtime on the day before CCTA evaluation.
Adverse events
none
Outcome measures
The primary endpoint was a
change in HR between enrollment in the study and the time of CCTA evaluation. The secondary endpoints
were elapsed time from arrival at the CCTA suite to starting CCTA image acquisition.
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
| 2023 | Year | 06 | Month | 26 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040160
| Research Plan | |
|---|---|
| Registered date | File name |
| 2023/06/26 | 東京ハートセンター倫理委員会用①.docx |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| 2023/06/26 | Pilot study of bisoprolol 8 mg transdermal patch at bedtime before.pdf |
| Research case data | |
|---|---|
| Registered date | File name |
| 2023/06/26 | Pilot study of bisoprolol 8 mg transdermal patch at bedtime before.pdf |
