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

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 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

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

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000051902


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name