UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000032799 |
|---|---|
| Receipt number | R000037379 |
| Scientific Title | Multicenter prospective observational study to examine the predictability of pathological assessment for staging of cardiomyopathy |
| Date of disclosure of the study information | 2018/06/01 |
| Last modified on | 2022/06/03 13:18:36 |
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Basic information
Public title
Multicenter prospective observational study to examine the predictability of pathological assessment for staging of cardiomyopathy
Acronym
Multicenter prospective observational study with pathological assessment in cardiomyopathy
Scientific Title
Multicenter prospective observational study to examine the predictability of pathological assessment for staging of cardiomyopathy
Scientific Title:Acronym
Multicenter prospective observational study with pathological assessment in cardiomyopathy
Region
| Japan |
Condition
Condition
cardiomyopathy
Classification by specialty
| Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To examine a pathological assessment with electron microscopy for predicting cardiac prognosis, including reverse remodeling, in multicenter prospective observational study and to investigate for the establishment of blood markers related to cardiac prognosis and pathological changes
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Cardiac event (cardiac death or LVAD implantation)
Key secondary outcomes
Reverse remodeling, change of LVEF, change of LV dimension
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 (LVEF<40%) who consent to participation and have a scheduled myocardial biopsy within 1 month
2. Patients without coronary artery disease or valvular disease as a major cause of cardiac dysfunction
Key exclusion criteria
1. Patients with systemic disease with poor prognosis (within 1 year)
2. Patients with LVAD support
3. no follow-up
4. Patients without standard treatment
5. Patients judged to be inappropriate by investigator
Target sample size
180
Research contact person
Name of lead principal investigator
| 1st name | Yasushi |
| Middle name | |
| Last name | Sakata |
Organization
Osaka University Graduate School of Medicine
Division name
Department of Cardiovascular Medicine
Zip code
565-0871
Address
2-2 Yamadaoka, Suita, Osaka, 565-0871 Japan
TEL
06-6879-3631
yasushisk@cardiology.med.osaka-u.ac.jp
Public contact
Name of contact person
| 1st name | Tomohito |
| Middle name | |
| Last name | Ohtani |
Organization
Osaka University Graduate School of Medicine
Division name
Department of Cardiovascular Medicine
Zip code
565-0871
Address
2-2 Yamadaoka, Suita, Osaka, 565-0871 Japan
TEL
06-6879-3638
Homepage URL
ohtani@cardiology.med.osaka-u.ac.jp
Sponsor or person
Institute
Osaka University
Institute
Department
Personal name
Funding Source
Organization
Japan Agency for Medical Research and Development
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Osaka University Clinical Research Review Committee
Address
Yamadaoka 2-15, Suita City, Osaka
Tel
06-6210-8296
rinri@hp-crc.med.osaka-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
大阪大学医学部附属病院（大阪府）、国立循環器病研究センター(大阪府)、東京大学医学部附属病院（東京都）、名古屋大学医学部附属病院（愛知県）、大阪急性期・総合医療センター（大阪府）
Other administrative information
Date of disclosure of the study information
| 2018 | Year | 06 | Month | 01 | 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
Completed
Date of protocol fixation
| 2018 | Year | 05 | Month | 27 | Day |
Date of IRB
| 2018 | Year | 05 | Month | 28 | Day |
Anticipated trial start date
| 2018 | Year | 06 | Month | 01 | Day |
Last follow-up date
| 2021 | Year | 06 | Month | 30 | Day |
Date of closure to data entry
| 2021 | Year | 09 | Month | 28 | Day |
Date trial data considered complete
| 2021 | Year | 10 | Month | 01 | Day |
Date analysis concluded
Other
Other related information
This study is a prospective observational study.
Data for analysis is as follows:
*Pathological findings (electron microscopic assessments)
*Cardiac events
*Echocardiographic data
*Patients characteristics, including laboratory data
Management information
Registered date
| 2018 | Year | 05 | Month | 31 | Day |
Last modified on
| 2022 | Year | 06 | Month | 03 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037379
| Research Plan | |
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| Registered date | File name |
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| Registered date | File name |
| Research case data | |
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