UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000033644 |
|---|---|
| Receipt number | R000038361 |
| Scientific Title | Study on pulmonary function imaging diagnosis by chest X-ray dynamics photographing with motion picture compatible flat panel detector.Application 1 in emergency area: For pulmonary embolism patients. |
| Date of disclosure of the study information | 2018/08/10 |
| Last modified on | 2022/02/11 13:09:38 |
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Basic information
Public title
Study on pulmonary function imaging diagnosis by chest X-ray dynamics photographing with motion picture compatible flat panel detector.Application 1 in emergency area: For pulmonary embolism patients.
Acronym
Clinical application of chest x-ray dynamic photography 1
Scientific Title
Study on pulmonary function imaging diagnosis by chest X-ray dynamics photographing with motion picture compatible flat panel detector.Application 1 in emergency area: For pulmonary embolism patients.
Scientific Title:Acronym
Clinical application of chest x-ray dynamic photography 1
Region
| Japan |
Condition
Condition
pulmonary embolism
Classification by specialty
| Emergency medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To compare the diagnostic ability of pulmonary embolism patients with chest x-ray dynamic imaging and contrast CT
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Phase II
Assessment
Primary outcomes
Sensitivity for diagnosis of pulmonary embolism in measurement method of heart rate variation of permeability of 18 lung fields by chest X-ray dynamic imaging apparatus with contrast CT examination as a reference
Key secondary outcomes
specificity for diagnosis of pulmonary embolism in measurement method of heart rate variation of permeability of 18 lung fields by chest X-ray dynamic imaging apparatus with contrast CT examination as a reference
Sensitivity and specificity of pulmonary embolism diagnosis of blood flow mapping image by chest x-ray dynamic imaging device
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Diagnosis
Type of intervention
| Device,equipment |
Interventions/Control_1
Chest x-ray dynamic photography
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1) Be an adult over 20 years old
2) Written informed consent
3) Patients suspected of pulmonary embolism or patients diagnosed with pulmonary embolism
4) Chest CT contrast test scheduled for diagnosis or follow-up of pulmonary embolism
Key exclusion criteria
1) have allergy to the contrast agent
2) During pregnancy, possibility of pregnancy, delivery within 28 days, breast-feeding
3) Psychiatric disorder or psychiatric symptoms are merged and it is judged difficult to participate in the trial
4) Severe cases (during artificial respiration, SpO2 <93% even when administered oxygen, wearing an extracorporeal circulation assisting device, shock index> 1, during noradrenaline administration, GCS <13)
5) Even if it does not apply to 4) above, the patient who judged treatment as priority by the attending physician
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | JIRO |
| Middle name | |
| Last name | SHIMADA |
Organization
Fukushima Medical University
Division name
Futaba Emergency General Medical Support Center
Zip code
9601247
Address
1 Hikariga-oka, Fukushima City, JAPAN
TEL
0245471111
jshimada@fmu.ac.jp
Public contact
Name of contact person
| 1st name | JIRO |
| Middle name | |
| Last name | SHIMADA |
Organization
Fukushima Medical University hospital
Division name
Emergency and Critical Care Center
Zip code
9601247
Address
1 Hikariga-oka, Fukushima City, JAPAN
TEL
0245471111
Homepage URL
jshimada@fmu.ac.jp
Sponsor or person
Institute
Fukushima Medical University
Institute
Department
Personal name
Funding Source
Organization
Konica Minolta Co., Ltd.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Fukushima Medical University Certified Review Board
Address
1 Hikariga-oka, Fukushima City, JAPAN
Tel
0245471111
fmucrb@fmu.ac.jp
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
| 2018 | Year | 08 | Month | 10 | 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
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
Terminated
Date of protocol fixation
| 2017 | Year | 10 | Month | 01 | Day |
Date of IRB
| 2018 | Year | 12 | Month | 18 | Day |
Anticipated trial start date
| 2017 | Year | 12 | Month | 01 | Day |
Last follow-up date
| 2021 | Year | 11 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Due to the coronavirus pandemic, case registration did not proceed and was canceled.
Management information
Registered date
| 2018 | Year | 08 | Month | 06 | Day |
Last modified on
| 2022 | Year | 02 | Month | 11 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038361
| Research Plan | |
|---|---|
| Registered date | File name |
| 2019/02/21 | 4認定臨床研究計画書 .pdf |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
