UMIN-CTR Clinical Trial

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
Email	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
Email	oike-fmi@kumamoto-u.ac.jp

Sponsor
Institute	Kumamoto University
Institute
Department

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
Email	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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000051902