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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000007217
Receipt No. 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

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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
Institute Osaka Ekisaikai Hospital
Institute
Department

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
URL(English) https://upload.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


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