UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000038307 |
|---|---|
| Receipt number | R000043660 |
| Scientific Title | Characteristics and prognosis study of real-world cardiac amyloidosis |
| Date of disclosure of the study information | 2019/11/01 |
| Last modified on | 2023/12/08 09:56:18 |
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Basic information
Public title
Characteristics and prognosis study of
real-world cardiac amyloidosis
Acronym
CAPTURE-AMYLOID
Scientific Title
Characteristics and prognosis study of
real-world cardiac amyloidosis
Scientific Title:Acronym
CAPTURE-AMYLOID
Region
| Japan |
Condition
Condition
Cardiac amyloidosis
Classification by specialty
| Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the characteristics of patients with cardiac amyloidosis
Basic objectives2
Others
Basic objectives -Others
To evaluate the prognosis of patients with cardiac amyloidosis
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
A composite of all-cause death and hospitalization for heart failure
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1. Patients who were diagnosed as cardiac amyloidosis after September 1, 2019
2. Patients in whom written informed consent was obtained
Key exclusion criteria
Patients in whom written informed consent was not obtained
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Takao |
| Middle name | |
| Last name | Kato |
Organization
Kyoto University Hospital
Division name
Department of Cardiovascular Medicine
Zip code
606-8507
Address
54 Shogoin-Kawahara-cho, Sakyo-ku, Kyoto 606-8507 Japan
TEL
075-751-4255
tkato75@kuhp.kyoto-u.ac.jp
Public contact
Name of contact person
| 1st name | Ryusuke |
| Middle name | |
| Last name | Nishikawa |
Organization
Kyoto University Hospital
Division name
Department of Cardiovascular Medicine
Zip code
606-8507
Address
54 Shogoin-Kawahara-cho, Sakyo-ku, Kyoto 606-8507 Japan
TEL
075-751-4255
Homepage URL
rn6072@kuhp.kyoto-u.ac.jp
Sponsor or person
Institute
Kyoto University Hospital
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
Kyoto University Graduate School and Faculty of Medicine Kyoto University Hospital Ethics Committe
Address
Yoshidakonoe-cho, Sakyo-ku, Kyoto 606-8501 Japan
Tel
075-753-4680
ethcom@kuhp.kyoto-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
| 2019 | Year | 11 | 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
141
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
| 2019 | Year | 10 | Month | 07 | Day |
Date of IRB
| 2019 | Year | 10 | Month | 07 | Day |
Anticipated trial start date
| 2019 | Year | 11 | Month | 01 | Day |
Last follow-up date
| 2024 | Year | 10 | Month | 07 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Prospective cohort study
Management information
Registered date
| 2019 | Year | 10 | Month | 16 | Day |
Last modified on
| 2023 | Year | 12 | Month | 08 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000043660
| 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 |
