UMIN-CTR Clinical Trial

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
Email	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
Email	kenkentakota@yahoo.co.jp

Sponsor
Institute	The Jikei University School of Medicine
Institute
Department

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
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	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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000048936

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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