UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000016145 |
|---|---|
| Receipt number | 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 16:16:31 |
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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
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
kunihara@jikei.ac.jp
Sponsor or person
Institute
The Jikei University
Institute
Department
Personal name
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
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
Value
https://center6.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 | |
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| Registered date | File name |
