UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000043834 |
|---|---|
| Receipt number | R000049417 |
| Scientific Title | The Association Between Beta2 Adrenergic Receptor Polymorphism and Coronary Microvascular Dysfunction |
| Date of disclosure of the study information | 2021/04/05 |
| Last modified on | 2024/10/06 13:10:00 |
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Basic information
Public title
The Association Between Beta2 Adrenergic Receptor Polymorphism and Coronary Microvascular Dysfunction
Acronym
The Association Between ADRB2 Polymorphism and Coronary Microvascular Dysfunction
Scientific Title
The Association Between Beta2 Adrenergic Receptor Polymorphism and Coronary Microvascular Dysfunction
Scientific Title:Acronym
The Association Between ADRB2 Polymorphism and Coronary Microvascular Dysfunction
Region
| Japan |
Condition
Condition
Coronary microvascular dysfunction
Classification by specialty
| Cardiology |
Classification by malignancy
Others
Genomic information
YES
Objectives
Narrative objectives1
To assess the association between Beta2 adrenergic receptor (ADRB2) gene polymorphism and coronary microvascular dysfunction
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Beta2 adrenergic receptor gene polymorphism was associated with coronary microvascular dysfunction.
Key secondary outcomes
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
| 15 | years-old | <= |
Age-upper limit
| 100 | years-old | > |
Gender
Male and Female
Key inclusion criteria
The patients with coronary microvascular dysfunction.
The patients with denied coronary artery disease (as control group).
The cases in medical checkup without cardiovascular diseases (as control group).
Key exclusion criteria
Other than those above.
Target sample size
800
Research contact person
Name of lead principal investigator
| 1st name | Kenichi |
| Middle name | |
| Last name | Tsujita |
Organization
Graduate School of Medical Sciences, Kumamoto University
Division name
Department of Cardiovascular Medicine
Zip code
860-8556
Address
1-1-1 Honjo, Chuo-ku, Kumamoto City 860-8556, Japan
TEL
0963735175
tsujita@kumamoto-u.ac.jp
Public contact
Name of contact person
| 1st name | Satoru |
| Middle name | |
| Last name | SUZUKI |
Organization
Graduate School of Medical Science,Kumamoto University
Division name
Department of Cardiovascular Medicine
Zip code
860-8556
Address
1-1-1 Honjo, Chuo-ku, Kumamoto City 860-8556, Japan
TEL
0963735175
Homepage URL
s-satoru@kumamoto-u.ac.jp
Sponsor or person
Institute
Kumamoto University
Institute
Department
Personal name
Funding Source
Organization
Kumamoto University
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
Kumamoto University
Address
1-1-1 Honjo, Chuo-ku, Kumamoto City 860-8556, Japan
Tel
0963735175
s-satoru@kumamoto-u.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
| 2021 | Year | 04 | Month | 05 | 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
1200
Results
Results date posted
Results Delayed
| Delay expected |
Results Delay Reason
This is because I am writing the paper.
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
No longer recruiting
Date of protocol fixation
| 2021 | Year | 01 | Month | 11 | Day |
Date of IRB
| 2021 | Year | 03 | Month | 29 | Day |
Anticipated trial start date
| 2021 | Year | 01 | Month | 11 | Day |
Last follow-up date
| 2021 | Year | 01 | Month | 11 | Day |
Date of closure to data entry
| 2024 | Year | 04 | Month | 10 | Day |
Date trial data considered complete
| 2024 | Year | 04 | Month | 10 | Day |
Date analysis concluded
Other
Other related information
The aim of this study is to investigate the association between coronary microvascular dysfunction and ADRB2 polymorphism.
Management information
Registered date
| 2021 | Year | 04 | Month | 04 | Day |
Last modified on
| 2024 | Year | 10 | Month | 06 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000049417
