UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000042874 |
|---|---|
| Receipt number | R000048936 |
| Scientific Title | Multicenter study on the usefulness of mitral valve repair with the addition of papillary muscle relocation for severe ischemic mitral regurgitation |
| Date of disclosure of the study information | 2021/01/04 |
| Last modified on | 2020/12/29 16:48:30 |
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Basic information
Public title
Multicenter study on the usefulness of mitral valve repair with the addition of papillary muscle relocation for severe ischemic mitral regurgitation
Acronym
Multicenter study on the usefulness of mitral valve repair with the addition of papillary muscle relocation for severe ischemic mitral regurgitation
Scientific Title
Multicenter study on the usefulness of mitral valve repair with the addition of papillary muscle relocation for severe ischemic mitral regurgitation
Scientific Title:Acronym
Multicenter study on the usefulness of mitral valve repair with the addition of papillary muscle relocation for severe ischemic mitral regurgitation
Region
| Japan |
Condition
Condition
severe ischemic mitral regurgitation
Classification by specialty
| Cardiovascular surgery |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The main purpose of this study is to compare clinical results of mitral valve replacement and mitral valvuloplasty using papillary muscle relocation for severe ischemic mitral regurgitation retrospectively.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Major adverse cardiac or cerebrovascular events and other serious adverse events
Key secondary outcomes
LV reverse remodeling represented by the end-systolic left ventricular volume index one year later, left ventricular diameter and contractility, and recurrence of moderate MR or more
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
| 16 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Cases in which elective mitral valvuloplasty or mitral valve replacement for severe ischemic mitral regurgitation 16 years or older performed from January 1, 2015 to December 31, 2019. Cases with additional coronary artery bypass grafting, tricuspid valve repair, and maze procedure can be included.
Key exclusion criteria
1. Emergency surgery cases such as acute infective endocarditis
2. Hypothermia surgery requiring circulatory arrest
3. Preoperative catecholamine or IABP use cases
4. When the patient requests withdrawal of information after announcing the right to opt-out
5. Other cases that the research doctor deems inappropriate for research
Target sample size
300
Research contact person
Name of lead principal investigator
| 1st name | Takashi |
| Middle name | |
| Last name | Kunihara |
Organization
The Jikei University School of Medicine
Division name
Department of Cardiac Surgery
Zip code
105-8461
Address
3-25-8 Nishishinbashi, Minato-ku, Tokyo 105-8461 Japan
TEL
03-3433-1111
kunihara@jikei.ac.jp
Public contact
Name of contact person
| 1st name | Ken |
| Middle name | |
| Last name | Nakamura |
Organization
Saitama Cardiovascular and Respiratory Center
Division name
Cardiovascular Surgery
Zip code
360-0197
Address
1696 Itai, Kumagaya City, Saitama, 360-0197 Japan
TEL
048-536-9900
Homepage URL
kenkentakota@yahoo.co.jp
Sponsor or person
Institute
The Jikei University School of Medicine
Institute
Department
Personal name
Funding Source
Organization
The Jikei 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
The Jikei University School of Medicine
Address
3-25-8, Nishishinbashi, Minato-ku, Tokyo 105-8461, Japan
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
| 2021 | Year | 01 | Month | 04 | 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
| 2021 | Year | 02 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2021 | Year | 02 | Month | 01 | Day |
Last follow-up date
| 2021 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
None
Management information
Registered date
| 2020 | Year | 12 | Month | 29 | Day |
Last modified on
| 2020 | Year | 12 | Month | 29 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000048936
