UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000013673 |
|---|---|
| Receipt number | R000015960 |
| Scientific Title | Study on factors related to early atrial fibrillation following cardiac surgery -the influence of epicardial adipose tissue- |
| Date of disclosure of the study information | 2015/04/08 |
| Last modified on | 2019/01/08 12:17:46 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Study on factors related to early atrial fibrillation following cardiac surgery -the influence of epicardial adipose tissue-
Acronym
Study on factors related to early atrial fibrillation following cardiac surgery
Scientific Title
Study on factors related to early atrial fibrillation following cardiac surgery -the influence of epicardial adipose tissue-
Scientific Title:Acronym
Study on factors related to early atrial fibrillation following cardiac surgery
Region
| Japan |
Condition
Condition
Patients undergoing cardiac surgery with cardiopulmonary bypass
Classification by specialty
| Cardiovascular surgery |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Searching for the factors of post operative atrial fibrillation analyzed with relationships among epicardial adipose tissue, inflammation, cytokine and fibrosis
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Occurrence of post operative atrial fibrillation
Key secondary outcomes
patients' characteristics, transthoracic echocardiography, Carto CT(left atrium volume, epicardial adipose tissue volume), Holter ECG, inflammation marker, fibrotic marker, fluid balance, hemodynamics
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients undergoing cardiovascular surgery with cardiopulmonary bypass
Key exclusion criteria
thyroid disease
inflammatory disease
malignancy
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yaoita Hiroko |
Organization
Nihon University Itabashi hospital
Division name
Cardiac Surgery
Zip code
Address
30-1Oyaguchikami-cho, Itabashi-ku, Tokyo, Japan
TEL
03-3972-8111
yaoita.h@gmail.com
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Yaoita Hiroko |
Organization
Nihon University Itabashi hospital
Division name
Cardiac Surgery
Zip code
Address
30-1Oyaguchikami-cho, Itabashi-ku, Tokyo, Japan
TEL
03-3972-8111
Homepage URL
yaoita.h@gmail.com
Sponsor or person
Institute
Nihon University Itabashi hospital Cardiac Surgery
Institute
Department
Personal name
Funding Source
Organization
Nihon University Itabashi hospital Cardiac Surgery
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
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
| 2015 | Year | 04 | Month | 08 | Day |
Related information
URL releasing protocol
Publication of results
Published
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
| 2014 | Year | 03 | Month | 15 | Day |
Date of IRB
Anticipated trial start date
| 2014 | Year | 03 | Month | 15 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
see article
Management information
Registered date
| 2014 | Year | 04 | Month | 08 | Day |
Last modified on
| 2019 | Year | 01 | Month | 08 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000015960
