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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000014663
Receipt No. R000017056
Scientific Title Three-dimensional transesophagial echocardiography for Tricuspid valve assessment during cardiac surgery
Date of disclosure of the study information 2014/08/01
Last modified on 2016/02/27

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Basic information
Public title Three-dimensional transesophagial echocardiography for Tricuspid valve assessment during cardiac surgery
Acronym Three-dimensional transesophagial echocardiography for Tricuspid valve assessment during cardiac surgery
Scientific Title Three-dimensional transesophagial echocardiography for Tricuspid valve assessment during cardiac surgery
Scientific Title:Acronym Three-dimensional transesophagial echocardiography for Tricuspid valve assessment during cardiac surgery
Region
Japan

Condition
Condition valve disease
Classification by specialty
Cardiology Anesthesiology Cardiovascular surgery
Operative medicine Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 tricuspid valve assesment
Basic objectives2 Others
Basic objectives -Others comparison,observational
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes postoperative right ventricular failure
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

Not applicable
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria none
Key exclusion criteria none
Target sample size 200

Research contact person
Last name of lead principal investigator
1st name
Middle name
Last name Takeshi Tateda
Organization St.Marianna University School of Medicine
Division name Anesthesiology
Zip code
Address Sugao 2-16-1 Miyamae Kawasaki Kanagawa
TEL 044-977-8111
Email t2tateda@marianna-u.ac.jp

Public contact
1st name of contact person
1st name
Middle name
Last name Yumi Obata
Organization St.Marianna University School of Medicine
Division name Anesthesiology
Zip code
Address Sugao 2-16-1 Miyamae Kawasaki Kanagawa
TEL 044-977-8111
Homepage URL
Email y2obata@marianna-u.ac.jp

Sponsor
Institute St.Marianna University School of Medicine
Institute
Department

Funding Source
Organization St.Marianna University School of Medicine
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
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 聖マリアンナ医科大学病院

Other administrative information
Date of disclosure of the study information
2014 Year 08 Month 01 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 Preinitiation
Date of protocol fixation
2014 Year 07 Month 27 Day
Date of IRB
Anticipated trial start date
2014 Year 08 Month 01 Day
Last follow-up date
2016 Year 03 Month 31 Day
Date of closure to data entry
2016 Year 03 Month 31 Day
Date trial data considered complete
2016 Year 06 Month 30 Day
Date analysis concluded
2016 Year 07 Month 31 Day

Other
Other related information postoperative right ventricular failure

Management information
Registered date
2014 Year 07 Month 27 Day
Last modified on
2016 Year 02 Month 27 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000017056

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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