UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000049302 |
|---|---|
| Receipt number | R000055352 |
| Scientific Title | Mechanism(s) of Expression of Epicardial Connection(s) between Atrium and Pulmonary Vein(s) |
| Date of disclosure of the study information | 2022/10/25 |
| Last modified on | 2024/06/10 08:24:50 |
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Basic information
Public title
Mechanism(s) of Expression of Epicardial Connection(s) between Atrium and Pulmonary Vein(s)
Acronym
Mechanism(s) of Expression of Epicardial Connection(s)
Scientific Title
Mechanism(s) of Expression of Epicardial Connection(s) between Atrium and Pulmonary Vein(s)
Scientific Title:Acronym
Mechanism(s) of Expression of Epicardial Connection(s)
Region
| Japan |
Condition
Condition
Atrial fibrillation
Classification by specialty
| Medicine in general | Cardiology | Pneumology |
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To determine whether left atrial remodeling and sleep disorder affect the expression the epicardial connection(s)
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Association among the Expression of Epicardial connections, Left atrial remodeling, and Sleep disorder
Key secondary outcomes
Base
Study type
Others,meta-analysis etc
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
| 20 | years-old | <= |
Age-upper limit
| 99 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Patients who perform ablation of AF
Key exclusion criteria
history of cardiac surgery, HD
Target sample size
400
Research contact person
Name of lead principal investigator
| 1st name | Masao |
| Middle name | |
| Last name | Takemoto |
Organization
Steel Memorial Yawata Hospital
Division name
Cardiovascular Center
Zip code
8058508
Address
Kitakyushu
TEL
09031975210
matakemo@outlook.jp
Public contact
Name of contact person
| 1st name | Masao |
| Middle name | |
| Last name | Takemoto |
Organization
Steel Memorial Yawata Hospital
Division name
Cardiovascular Center
Zip code
8058508
Address
Kitakyushu
TEL
0936723176
Homepage URL
matakemo@outlook.jp
Sponsor or person
Institute
Steel Memorial Yawata 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
Steel Memorial Yawata Hospital
Address
the institutional review committee and ethics review board of our hospital, the Ethical Review Board of Steel Memorial Yawata Hospital
Tel
0936723176
shimono.s@ns.yawata-mhp.or.jp
Secondary IDs
Secondary IDs
YES
Study ID_1
21-61-01
Org. issuing International ID_1
Steel Memorial Yawata Hospital
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2022 | Year | 10 | Month | 25 | 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
Completed
Date of protocol fixation
| 2019 | Year | 08 | Month | 01 | Day |
Date of IRB
| 2021 | Year | 03 | Month | 09 | Day |
Anticipated trial start date
| 2019 | Year | 08 | Month | 01 | Day |
Last follow-up date
| 2022 | Year | 09 | Month | 30 | Day |
Date of closure to data entry
| 2023 | Year | 04 | Month | 25 | Day |
Date trial data considered complete
| 2023 | Year | 04 | Month | 25 | Day |
Date analysis concluded
| 2023 | Year | 04 | Month | 25 | Day |
Other
Other related information
evaluation of the effect of sleep disorder on atrial remodeling and expression of epicardial connections
Management information
Registered date
| 2022 | Year | 10 | Month | 25 | Day |
Last modified on
| 2024 | Year | 06 | Month | 10 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000055352
