UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000049998 |
|---|---|
| Receipt number | R000056947 |
| Scientific Title | Validation of right ventricular endomyocardial biopsy as a surrogate marker of left ventricular fibrosis in dilated cardiomyopathy |
| Date of disclosure of the study information | 2023/01/11 |
| Last modified on | 2024/01/11 09:10:39 |
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Basic information
Public title
Validation of right ventricular endomyocardial biopsy as a surrogate marker of left ventricular fibrosis in dilated cardiomyopathy
Acronym
Biopsy as a surrogate maker for left ventricular fibrosis
Scientific Title
Validation of right ventricular endomyocardial biopsy as a surrogate marker of left ventricular fibrosis in dilated cardiomyopathy
Scientific Title:Acronym
Biopsy as a surrogate maker for left ventricular fibrosis
Region
| Japan |
Condition
Condition
dilated cardiomyopathy
Classification by specialty
| Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To compare the extent of fibrosis on right ventricular (RV) endomyocardial biopsy (EMB) and left ventricular (LV) fibrosis on excised hearts, and to assess the correlation between RV-EMB and LV- fibrosis in dilated cardiomyopathy (DCM).
Basic objectives2
Others
Basic objectives -Others
Correlation analysis between histopathology and imaging diagnosis
Trial characteristics_1
Confirmatory
Trial characteristics_2
Others
Developmental phase
Not applicable
Assessment
Primary outcomes
Association of right ventricular (RV) endocardial myocardial biopsy (EMB) histopathology with the degree of left ventricular (LV) fibrosis in explanted hearts that subsequently underwent pathologic dissection or heart transplantation.
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1) Patients who have had pathological evaluation performed in the Pathology Department of our institution.
2) For autopsy cases, patients who had a right ventricular endocardial biopsy performed prior to death.
3) For heart transplant cases, patients who have undergone right ventricular endocardial biopsy prior to transplantation.
Key exclusion criteria
1) Patients with coronary artery disease, previous cardiac surgery (excluding assistive device implantation including LVAD), or apparent acute myocarditis.
2) Patients who have declared non-participation in the study after reading the opt-out document.
3) Patients who are deemed inappropriate by the Principal Investigator or the Principal Investigator.
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Kinta |
| Middle name | |
| Last name | Hatakeyama |
Organization
National Cerebral and Cardiovascular Center
Division name
Department of Pathology
Zip code
564-8565
Address
6-1 Kishibe-Shimmachi, Suita, Osaka
TEL
+81-(6)6-6170-1070
kpathol@ncvc.go.jp
Public contact
Name of contact person
| 1st name | Kisaki |
| Middle name | |
| Last name | Amemiya |
Organization
National Cerebral and Cardiovascular Center
Division name
Department of Pathology
Zip code
564-8565
Address
6-1 Kishibe-Shimmachi, Suita, Osaka
TEL
+81-(6)6-6170-1070
Homepage URL
amemiya.kisaki@ncvc.go.jp
Sponsor or person
Institute
National Cerebral and Cardiovascular Center
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
JAPAN
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
National Cerebral and Cardiovascular Center
Address
6-1 Kishibe-Shimmachi, Suita, Osaka
Tel
+81-(6)6170-1070
clinical.research.desk@ncvc.go.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
国立循環器病研究センター
Other administrative information
Date of disclosure of the study information
| 2023 | Year | 01 | Month | 11 | 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
70
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
No longer recruiting
Date of protocol fixation
| 2021 | Year | 09 | Month | 24 | Day |
Date of IRB
| 2021 | Year | 11 | Month | 19 | Day |
Anticipated trial start date
| 2021 | Year | 11 | Month | 19 | Day |
Last follow-up date
| 2023 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
To determine the relationship between right ventricular endocardial myocardial biopsy histopathology and the extent of left ventricular fibrosis in explanted hearts that subsequently underwent pathologic dissection or heart transplantation.
Management information
Registered date
| 2023 | Year | 01 | Month | 10 | Day |
Last modified on
| 2024 | Year | 01 | Month | 11 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000056947
