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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000007911
Receipt No. 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

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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
Email 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
Email asezai.med@gmail.com

Sponsor
Institute Nihon University school of medicine
Institute
Department

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
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000009319

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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