UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000044021 |
|---|---|
| Receipt number | R000044072 |
| Scientific Title | An investigation to establish the practical approach for diagnosis of wild-type transthyretin cardiac amyloidosis |
| Date of disclosure of the study information | 2024/03/31 |
| Last modified on | 2023/04/21 10:23:11 |
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Basic information
Public title
An investigation to establish the practical approach for diagnosis of wild-type transthyretin cardiac amyloidosis
Acronym
An investigation to establish the practical approach for diagnosis of wild-type transthyretin cardiac amyloidosis
Scientific Title
An investigation to establish the practical approach for diagnosis of wild-type transthyretin cardiac amyloidosis
Scientific Title:Acronym
An investigation to establish the practical approach for diagnosis of wild-type transthyretin cardiac amyloidosis
Region
| Japan |
Condition
Condition
wild-type transthyretin cardiac amyloidosis
Classification by specialty
| Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To establish the practical approach for early diagnosis of wild-type transthyretin cardiac amyloidosis
Basic objectives2
Others
Basic objectives -Others
Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
To establish the practical approach for early diagnosis of wild-type transthyretin cardiac amyloidosis
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
| 70 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
out patients with equal to or greater than 70 years old
Key exclusion criteria
patients with hemodialysis, patients with history of heart failure hospitalization
Target sample size
1600
Research contact person
Name of lead principal investigator
| 1st name | Toru |
| Middle name | |
| Last name | Kubo |
Organization
Kochi Medical School, Kochi University
Division name
Department of Cardiology and Geriatrics
Zip code
783-8505
Address
Kohasu, Nankoku-shi, Kochi-ken, JAPAN
TEL
088-880-2352
jm-kubotoru@kochi-u.ac.jp
Public contact
Name of contact person
| 1st name | Minaguchi, Tabuchi |
| Middle name | |
| Last name | Minaguchi, Tabuchi |
Organization
Kochi Medical School Hospital
Division name
Kochi Medical School Hospital
Zip code
783-8505
Address
Kohasu, Nankoku-shi, Kochi-ken, JAPAN
TEL
088-880-2797
Homepage URL
http://www.kochi-ms.ac.jp/~fm_gratr/
rinri21@kochi-u.ac.jp
Sponsor or person
Institute
Kochi Medical School, Kochi University
Institute
Department
Personal name
Funding Source
Organization
None
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
Kochi Medical School Hospital
Address
Kohasu, Nankoku-shi, Kochi-ken, JAPAN
Tel
088-880-2797
rinri21@kochi-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
Other administrative information
Date of disclosure of the study information
| 2024 | Year | 03 | Month | 31 | 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
1142
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
Enrolling by invitation
Date of protocol fixation
| 2019 | Year | 12 | Month | 20 | Day |
Date of IRB
| 2019 | Year | 12 | Month | 20 | Day |
Anticipated trial start date
| 2020 | Year | 01 | Month | 01 | Day |
Last follow-up date
| 2024 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2024 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
Date analysis concluded
Other
Other related information
Observational study
Management information
Registered date
| 2021 | Year | 04 | Month | 23 | Day |
Last modified on
| 2023 | Year | 04 | Month | 21 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000044072
