UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000058860 |
|---|---|
| Receipt number | R000067313 |
| Scientific Title | Histopathological Findings of Myocardium in Patients with Primary Mitral Regurgitation: Association between Postoperative Course and Computed Tomography-Derived Extracellular Volume Fraction |
| Date of disclosure of the study information | 2025/08/22 |
| Last modified on | 2025/08/21 23:13:57 |
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Basic information
Public title
A Study on the Changes in Heart Muscle Caused by Mitral Regurgitation
Acronym
Study on Heart Damage Caused by MR
Scientific Title
Histopathological Findings of Myocardium in Patients with Primary Mitral Regurgitation: Association between Postoperative Course and Computed Tomography-Derived Extracellular Volume Fraction
Scientific Title:Acronym
Histopathological Myocardial Findings in Primary MR: Relation to Postoperative Outcomes and CT-Derived ECV
Region
| Japan |
Condition
Condition
Degenerative mitral regurgitation
Classification by specialty
| Cardiovascular surgery |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The present study aims to elucidate the histopathological characteristics of myocardial tissue, including fibrosis, using left atrial and left ventricular biopsy specimens obtained during mitral valve repair in patients with degenerative mitral regurgitation (DMR). Furthermore, it seeks to investigate how these histological findings are associated with postoperative left ventricular function and clinical outcomes such as the maintenance of sinus rhythm. In addition, by examining the correlation between computed tomography-derived extracellular volume fraction (CT-ECV), a noninvasive imaging modality, and histological markers of myocardial fibrosis, this study aims to clarify the clinical utility of CT-ECV.
Basic objectives2
Others
Basic objectives -Others
In this study, we will investigate the association between histopathological findings of intraoperatively obtained myocardial biopsy specimens and postoperative left ventricular reverse remodeling in patients with degenerative mitral regurgitation (DMR) undergoing mitral valve repair.
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
Presence of Left Ventricular Reverse Remodeling
Left ventricular reverse remodeling will be defined as a reduction of more than 15% in the left ventricular end-systolic volume index (LVESVi) on transthoracic echocardiography performed postoperatively compared with the preoperative value.
Key secondary outcomes
Correlation Between CT-ECV and Histological CVF and ECV
The correlation between preoperative CT-derived extracellular volume fraction (CT-ECV) and histological collagen volume fraction (CVF) as well as histological ECV, both semi-quantitatively calculated from Masson-Trichrome-stained myocardial biopsy specimens using image analysis software, will be evaluated. In addition, the anatomical consistency between the measurement regions of CT-ECV and the corresponding biopsy sites will be examined.
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
No need to know
Intervention
No. of arms
1
Purpose of intervention
Diagnosis
Type of intervention
| Maneuver |
Interventions/Control_1
In patients with primary mitral regurgitation (degenerative mitral regurgitation, DMR) undergoing mitral valve repair, myocardial tissue will be obtained intraoperatively.
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1) Patients enrolled on or after the initiation date of the present study in the existing observational cohort study entitled "A Cohort Study on the Association Between Preoperative Cardiac CT-Derived Extracellular Volume Fraction and Postoperative Left Ventricular Reverse Remodeling in Patients with Primary Mitral Regurgitation" (March 1, 2024-March 31, 2029).
2) Patients who have received a thorough explanation of this study and have provided written informed consent.
Key exclusion criteria
1) Patients in whom intraoperative myocardial biopsy is deemed technically difficult to perform or associated with significant risk, as determined by the operating surgeon.
2) Patients judged by the investigators or the attending physician to be inappropriate for participation in this study.
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Takahashi |
| Middle name | |
| Last name | Hiroaki |
Organization
Kobe University Hospital
Division name
Department of Cardiovascular Surgery
Zip code
650-0017
Address
7-5-1, Kusunokimachi-town, Chuo-ward, Kobe City
TEL
0783825942
daiki522@med.kobe-u.ac.jp
Public contact
Name of contact person
| 1st name | Kato |
| Middle name | |
| Last name | Daiki |
Organization
Kobe University Hospital
Division name
Department of Cardiovascular Surgery
Zip code
650-0017
Address
7-5-1, Kusunokimachi-town, Chuo-ward, Kobe City
TEL
0783825942
Homepage URL
daiki522@med.kobe-u.ac.jp
Sponsor or person
Institute
Kobe University
Institute
Department
Personal name
Funding Source
Organization
N.A
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
Department of Cardiovascular Surgery, Kobe University Hospital
Address
7-5-1, Kusunokimachi-town, Chuo-ward, Kobe City
Tel
0783825942
daiki522@med.kobe-u.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
神戸大学病院
Other administrative information
Date of disclosure of the study information
| 2025 | Year | 08 | Month | 22 | 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
| 2025 | Year | 10 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2025 | Year | 10 | Month | 01 | Day |
Last follow-up date
| 2030 | Year | 06 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2025 | Year | 08 | Month | 21 | Day |
Last modified on
| 2025 | Year | 08 | Month | 21 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000067313
