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
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
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
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
