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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000016145
Receipt No. R000018744
Scientific Title The registry of aortic root reconstruction
Date of disclosure of the study information 2015/01/07
Last modified on 2019/07/22

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Basic information
Public title The registry of aortic root reconstruction
Acronym The registry of aortic root reconstruction
Scientific Title The registry of aortic root reconstruction
Scientific Title:Acronym The registry of aortic root reconstruction
Region
Japan

Condition
Condition Aortic valve regurgitation with annulo-aortic ectasia
Classification by specialty
Cardiovascular surgery
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To evaluate the morphologic and hemodynamical change after the aortic root reconstruction
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes cardiac function using echocardiography and MACCE (major adverse cardiovascular and cerebral event)
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 (1)elective cases who underwent aortic root reconstruction
(2)cases who underwent other concomitant cardiac operation via a median sternotomy
(3)cases who gave their documentary consent to this study
Key exclusion criteria (1) emergent aortic root reconstruction surgery such as acute aortic dissection or infective endocarditis or trauma
(2) history of other cardiac and aortic operation via a median sternotomy prior to aortic root reconstruction
Target sample size 200

Research contact person
Name of lead principal investigator
1st name Takashi
Middle name
Last name Kunihara
Organization The Jikei University
Division name Cardiac Surgery
Zip code 105-8471
Address 3-25-8 Nishi-shinbashi Minato-ku Tokyo
TEL 03-3433-1111
Email kunihara@jikei.ac.jp

Public contact
Name of contact person
1st name Takashi
Middle name
Last name Kunihara
Organization The Jikei University
Division name Cardiac Surgery
Zip code 105-8461
Address 3-25-8 Nishi-shinbashi Minato-ku Tokyo
TEL 03-3433-1111
Homepage URL
Email kunihara@jikei.ac.jp

Sponsor
Institute The Jikei University
Institute
Department

Funding Source
Organization The Jikei University
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 The Jikei University
Address 3-25-8 Nishi-shinbashi Minato-ku Tokyo
Tel 03-3433-1111
Email kunihara@jikei.ac.jp

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 01 Month 07 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 Open public recruiting
Date of protocol fixation
2015 Year 01 Month 01 Day
Date of IRB
Anticipated trial start date
2015 Year 01 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 cardiac function using echocardiography and MACCE
(major adverse cardiovascular and cerebral event)

Management information
Registered date
2015 Year 01 Month 07 Day
Last modified on
2019 Year 07 Month 22 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000018744

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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