UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000041174 |
|---|---|
| Receipt number | R000046966 |
| Scientific Title | Diagnostic performance and prognostic significance of myocardial pathological findings in cardiomyopathy |
| Date of disclosure of the study information | 2020/07/22 |
| Last modified on | 2024/04/08 09:16:28 |
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Basic information
Public title
Diagnostic performance and prognostic significance of myocardial pathological findings in cardiomyopathy
Acronym
Myocardial pathology in cardiomyopathy
Scientific Title
Diagnostic performance and prognostic significance of myocardial pathological findings in cardiomyopathy
Scientific Title:Acronym
Myocardial pathology in cardiomyopathy
Region
| Japan |
Condition
Condition
cardiomyopathy
Classification by specialty
| Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To examine the diagnostic performance and prognostic relevance of myocardial biopsy findings (e.g., pathology and molecular analysis findings) in cardiomyopathy
Basic objectives2
Others
Basic objectives -Others
none
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The relationship between findings obtained from myocardial biopsy and the rate of accurate diagnosis in various cardiomyopathies.
The relationship between myocardial biopsy findings and adverse events including all-cause death, cardiovascular death, and heart failure hospitalization.
Key secondary outcomes
The relationship between findings obtained from myocardial biopsy and events including fatal arrhythmias, new device implantation, left ventricular assist device implantation, and heart transplantation.
The relationship between findings obtained from myocardial biopsy and cardiac MRI, cardiac PET, and blood tests.
Trajectory of pathohistological findings in myocardial tissue.
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
| 18 | years-old | <= |
Age-upper limit
| 120 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
(1) 18 years of age or older
(2) Those who have given their voluntary consent to participate in this study or who do not refuse to participate in the study.
Key exclusion criteria
(1) Patients who are considered as inappropriate candidate for this study by the principal investigator
Target sample size
900
Research contact person
Name of lead principal investigator
| 1st name | Toshiyuki |
| Middle name | |
| Last name | Nagai |
Organization
Faculty of Medicine and Graduate School of Medicine, Hokkaido University
Division name
Department of Cardiovascular Medicine
Zip code
060-8638
Address
Kita-15 Nishi-7, Kita-ku, Sapporo, Hokkaido 060-8638, Japan
TEL
011-706-6973
nagai@med.hokudai.ac.jp
Public contact
Name of contact person
| 1st name | Atsushi |
| Middle name | |
| Last name | Tada |
Organization
Faculty of Medicine and Graduate School of Medicine, Hokkaido University
Division name
Department of Cardiovascular Medicine
Zip code
060-8638
Address
Kita-15 Nishi-7, Kita-ku, Sapporo, Hokkaido 060-8638, Japan
TEL
011-706-6973
Homepage URL
atsushi-tada.0409@med.hokudai.ac.jp
Sponsor or person
Institute
Department of Cardiovascular Medicine, Faculty of Medicine and Graduate School of Medicine, Hokkaido University
Institute
Department
Personal name
Funding Source
Organization
Non profit foundation
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Hokkaido University Faculty of Medicine and Graduate School of Medicine Independent Clinical Research Review Committee
Address
Kita 15 Nishi 7, Kita-ku, Sapporo, Hokkaido
Tel
011-706-5003
shomu@med.hokudai.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
| 2020 | Year | 07 | 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
Open public recruiting
Date of protocol fixation
| 2020 | Year | 07 | Month | 14 | Day |
Date of IRB
| 2020 | Year | 07 | Month | 14 | Day |
Anticipated trial start date
| 2020 | Year | 07 | Month | 22 | Day |
Last follow-up date
| 2040 | 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 | 07 | Month | 21 | Day |
Last modified on
| 2024 | Year | 04 | Month | 08 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000046966
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
