UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000007217
Receipt number R000008498
Scientific Title Diagnostic Accuracy and Cost-effectiveness of Pocket-sized Transthoracic Echocardiographic Imaging Device
Date of disclosure of the study information 2012/02/03
Last modified on 2013/08/05 15:49:32

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Basic information

Public title

Diagnostic Accuracy and Cost-effectiveness of Pocket-sized Transthoracic Echocardiographic Imaging Device

Acronym

Accuracy and Cost-effectiveness of Pocket-sized Echocardiography

Scientific Title

Diagnostic Accuracy and Cost-effectiveness of Pocket-sized Transthoracic Echocardiographic Imaging Device

Scientific Title:Acronym

Accuracy and Cost-effectiveness of Pocket-sized Echocardiography

Region

Japan


Condition

Condition

Patients who are scheduled for standard standard transthoracic echocardiography

Classification by specialty

Cardiology

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To examine the feasibility and diagnostic accuracy of pocket-sized transthoracic echocardiography in clinical practice as compared with the results of standard transthoracic echocardiography, and to investigate its cost-effectiveness.

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

The presence of left ventricular hypertrophy, 2) left ventricular systolic dysfunction, 3) left ventricular regional wall motion abnormalities, 4) left atrial enlargement, 5) right ventricular dilatation, 6) dilated ascending aorta, 7) pericardial effusion, and 8) more than moderate valvular heart disease.

Key secondary outcomes



Base

Study type

Interventional


Study design

Basic design

Single arm

Randomization

Non-randomized

Randomization unit


Blinding

Open -but assessor(s) are blinded

Control

Uncontrolled

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

1

Purpose of intervention

Prevention

Type of intervention

Device,equipment

Interventions/Control_1

To perform pocket-sized transthoracic echocardiography

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

Patients who are scheduled for standard transthoracic echocardiography

Key exclusion criteria

None

Target sample size

400


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Shota Fukuda

Organization

Osaka Ekisaikai Hospital

Division name

Department of Medicine

Zip code


Address

2-1-10 Honden, Nishi-ku, Osaka

TEL


Email



Public contact

Name of contact person

1st name
Middle name
Last name

Organization

Osaka Ekisaikai Hospital

Division name

Department of Medicine

Zip code


Address


TEL


Homepage URL


Email

h-syouta@mve.biglobe.ne.jp


Sponsor or person

Institute

Osaka Ekisaikai Hospital

Institute

Department

Personal name



Funding Source

Organization

None

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization



Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization


Address


Tel


Email



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

2012 Year 02 Month 03 Day


Related information

URL releasing protocol


Publication of results

Published


Result

URL related to results and publications


Number of participants that the trial has enrolled


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 02 Month 03 Day

Date of IRB


Anticipated trial start date

2012 Year 02 Month 01 Day

Last follow-up date

2013 Year 03 Month 25 Day

Date of closure to data entry

2013 Year 03 Month 25 Day

Date trial data considered complete

2013 Year 03 Month 25 Day

Date analysis concluded

2013 Year 03 Month 25 Day


Other

Other related information



Management information

Registered date

2012 Year 02 Month 03 Day

Last modified on

2013 Year 08 Month 05 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000008498


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name