UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000007911 |
|---|---|
| Receipt number | R000009319 |
| Scientific Title | A search for a biomarker to predict the occurrence of atrial fibrillation prior to cardiac surgery |
| Date of disclosure of the study information | 2012/05/08 |
| Last modified on | 2014/10/27 13:15:46 |
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Basic information
Public title
A search for a biomarker to predict the occurrence of atrial fibrillation prior to cardiac surgery
Acronym
A search for a biomarker to predict the occurrence of atrial fibrillation prior to cardiac surgery
Scientific Title
A search for a biomarker to predict the occurrence of atrial fibrillation prior to cardiac surgery
Scientific Title:Acronym
A search for a biomarker to predict the occurrence of atrial fibrillation prior to cardiac surgery
Region
| Japan |
Condition
Condition
Patient who undergoing cardia surgery
Classification by specialty
| Cardiovascular surgery |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To search for a biomarker to predict to atrial fibrillation after cardiac surgery
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
hyaluronan, KL-6, I-CTP, ANP, angiotensin-II
Key secondary outcomes
incidence of postoperative atrial fibrillation
Age
LA diameter
BNP
hs-CRP
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
| 20 | years-old | <= |
Age-upper limit
| 90 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
patients from whom informed consent was obtained
Key exclusion criteria
Doctor's decision not to register to this regimen
Target sample size
800
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Akira Sezai |
Organization
Nihon University school of medicine
Division name
Department of Cardiovascular Surgery
Zip code
Address
30-1 Oyaguchi kami-machi, Itabashi-ku, Tokyo, Japan
TEL
03-3982-8111
asezai.med@gmail.com
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Akira Sezai |
Organization
Nihon University school of medicine
Division name
Department of Cardiovascular Surgery
Zip code
Address
30-1 Oyagichi kami-machi, Itabashi-ku, Tokyo
TEL
03-3972-8111
Homepage URL
asezai.med@gmail.com
Sponsor or person
Institute
Nihon University school of medicine
Institute
Department
Personal name
Funding Source
Organization
A grant for scientific research from the Japanese Ministry of Education, Culture, Sports, Science and Technology
Organization
Division
Category of Funding Organization
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
日本大学医学部付属板橋病院
Other administrative information
Date of disclosure of the study information
| 2012 | Year | 05 | Month | 08 | 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
| 2005 | Year | 01 | Month | 15 | Day |
Date of IRB
Anticipated trial start date
| 2005 | Year | 02 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Prospective study
Management information
Registered date
| 2012 | Year | 05 | Month | 08 | Day |
Last modified on
| 2014 | Year | 10 | Month | 27 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000009319
