UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000041537 |
|---|---|
| Receipt number | R000047284 |
| Scientific Title | Study for usefulness on cardiac CT strain in evaluation of pathology in cardiac amyloidosis |
| Date of disclosure of the study information | 2020/09/01 |
| Last modified on | 2022/08/29 08:06:24 |
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Basic information
Public title
Study for usefulness on cardiac CT strain in evaluation of pathology in cardiac amyloidosis
Acronym
CT strain in cardiac amyloidosis
Scientific Title
Study for usefulness on cardiac CT strain in evaluation of pathology in cardiac amyloidosis
Scientific Title:Acronym
CT strain in cardiac amyloidosis
Region
| Japan |
Condition
Condition
Cardiac amyloidosis
Classification by specialty
| Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Evaluate the diagnostic ability, severity and prognosis of cardiac amyloidosis using cardiac CT strain
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
Diagnostic ability and prognosis of 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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
morethan 20 years old,
cardiac CT and echocardiography are performed within 60 days,
In case of suspected cardiac amyloidosis, cardiac CT is performed for screening coronary artery disease, evaluation of cardiac thrombosis and TAVI,
In case of confirmed cardiac amyloidosis,cardiac CT is performed patients with passed over 2 years after CAG, angina pectoris (even in asymptomatic include a case where there is a ECG changes) or 2 or more coronary risk factors, and eGFR > 45 mL/min/1.73m2 (excluding dialysis patients)
Key exclusion criteria
Patients with a history of hypersensitivity to iodine or iodine contrast media,Patients with asthma and uncontrolled hyperthyroidism, Pregnant and lactating patients,Patients with arrhythmia during cardiac CT imaging,When the investigator determines that it is inappropriate to participate in the research (for example dementia patients)
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Masaki |
| Middle name | |
| Last name | Kinoshita |
Organization
Ehime University Graduate School of Medicine
Division name
Cardiology, Pulmonology, Hypertension and Nephrology
Zip code
791-0295
Address
Shitsukawa, Toon City, Ehime
TEL
089-960-5303
mkino0303@gmail.com
Public contact
Name of contact person
| 1st name | Masaki |
| Middle name | |
| Last name | Kinoshita |
Organization
Ehime University Graduate School of Medicine
Division name
Cardiology, Pulmonology, Hypertension and Nephrology
Zip code
791-0295
Address
Shitsukawa, Toon City, Ehime
TEL
089-960-5303
Homepage URL
mkino0303@gmail.com
Sponsor or person
Institute
Ehime University Graduate School of Medicine
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
Institutional Review Board,Ehime University Hospital
Address
Shitsukawa, Toon, Ehime
Tel
089-960-5172
rinri@m.ehime-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
| 2020 | Year | 09 | 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
0
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
Terminated
Date of protocol fixation
| 2020 | Year | 04 | Month | 01 | Day |
Date of IRB
| 2020 | Year | 04 | Month | 28 | Day |
Anticipated trial start date
| 2020 | Year | 06 | Month | 01 | Day |
Last follow-up date
| 2030 | Year | 03 | Month | 31 | 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
| 2020 | Year | 08 | Month | 25 | Day |
Last modified on
| 2022 | Year | 08 | Month | 29 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000047284
| 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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