UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000045458 |
|---|---|
| Receipt number | R000051902 |
| Scientific Title | Clinical significance of combination of left atrial and left ventricular function estimated by two-dimensional speckle tracking echocardiography for diagnosis of concomitant transthyretin amyloid cardiomyopathy in patients with aortic stenosis |
| Date of disclosure of the study information | 2021/09/12 |
| Last modified on | 2021/09/12 12:33:06 |
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Basic information
Public title
Clinical significance of combination of left atrial and left ventricular function estimated by two-dimensional speckle tracking echocardiography for diagnosis of concomitant transthyretin amyloid cardiomyopathy in patients with aortic stenosis
Acronym
Peak LSR and RapLSI are useful in ATTR-CM with AS
Scientific Title
Clinical significance of combination of left atrial and left ventricular function estimated by two-dimensional speckle tracking echocardiography for diagnosis of concomitant transthyretin amyloid cardiomyopathy in patients with aortic stenosis
Scientific Title:Acronym
Peak LSR and RapLSI are useful in ATTR-CM with AS
Region
| Japan |
Condition
Condition
Transthyretin amyloid cardiomyopathy
Classification by specialty
| Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To clarify the usefulness of left atrial (LA) function and left ventricular (LV) function obtained by two-dimensional (2D) speckle tracking echocardiography to diagnose concomitant transthyretin amyloid cardiomyopathy (ATTR-CM) in patients with Aortic stenosis (AS).
Basic objectives2
Others
Basic objectives -Others
Peak longitudinal strain in left atrium and relative apical longitudinal index in left ventricule.
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
left atrial (LA) function and left ventricular (LV) function obtained by two-dimensional (2D) speckle tracking echocardiography
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
| 90 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Patients with moderate to severe aortic stenosis who underwent 99mTc-pyrophosphate (PYP) scintigraphy at Kumamoto University Hospital.
Key exclusion criteria
Insufficient information for 2D speckle tracking echocardiography.
Target sample size
72
Research contact person
Name of lead principal investigator
| 1st name | Kenichi |
| Middle name | |
| Last name | Tsujita |
Organization
Kumamoto University
Division name
Cardiovascular Medicine
Zip code
8608556
Address
1-1-1 Honjo, Chuo-ku, Kumamoto
TEL
0963735175
tsujita@kumamoto-u.ac.jp
Public contact
Name of contact person
| 1st name | Fumi |
| Middle name | |
| Last name | Oike |
Organization
Kumamoto University
Division name
Cardiovascular Medicine
Zip code
8608556
Address
1-1-1 Honjo, Chuo-ku, Kumamoto
TEL
0963735175
Homepage URL
oike-fmi@kumamoto-u.ac.jp
Sponsor or person
Institute
Kumamoto University
Institute
Department
Personal name
Funding Source
Organization
Grant-in-Aid for Scientific Research from the Japan Society for the Promotion of Science
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
Kumamoto university certified clinical research review board
Address
1-1-1 Honjo, Chuo-ku, Kumamoto
Tel
0963735842
Not applicable
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
| 2021 | Year | 09 | Month | 12 | 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
75
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
| 2012 | Year | 01 | Month | 01 | Day |
Date of IRB
| 2012 | Year | 01 | Month | 01 | Day |
Anticipated trial start date
| 2012 | Year | 01 | Month | 01 | Day |
Last follow-up date
| 2020 | Year | 09 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
nothing
Management information
Registered date
| 2021 | Year | 09 | Month | 12 | Day |
Last modified on
| 2021 | Year | 09 | Month | 12 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000051902
