UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000033497 |
|---|---|
| Receipt number | R000038199 |
| Scientific Title | Study on pulmonary perfusion blood flow and prognosis of venous thromboembolism |
| Date of disclosure of the study information | 2018/07/25 |
| Last modified on | 2018/07/24 18:59:44 |
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Basic information
Public title
Study on pulmonary perfusion blood flow and prognosis of venous thromboembolism
Acronym
pulmonary perfusion blood flow
Scientific Title
Study on pulmonary perfusion blood flow and prognosis of venous thromboembolism
Scientific Title:Acronym
pulmonary perfusion blood flow
Region
| Japan |
Condition
Condition
Venous thromboembolism
Classification by specialty
| Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Venous thromboembolism is a disease that is occasionally lethal due to pulmonary embolism, and it is one of diseases with a high incidence in university hospitals dealing with many malignant diseases. IQon Spectral CT newly introduced at our hospital since January this year is a multi-slice CT equipped with a dual layer detector, and spectral imaging by this CT is based on incident X-rays obtained by spectroscopy of continuous X- Multiple energy and its accompanying substance interactions are utilized, and composite image analysis results and new substance information by conventional CT images and various spectral images can be obtained in all inspections. As a result, not only anatomical findings but also information on lung perfusion blood flow rate can be obtained for pulmonary embolism (D. Sueta, D. Utsunomiya et al.. Anticoagulation therapy has been established as the first choice for treatment of pulmonary embolism, but its efficacy evaluation has not been sufficiently elucidated. By evaluating lung perfusion blood flow before and after the treatment of patients who evaluated images in our venous thromboembolic event this time we can quantitatively evaluate their efficacy.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
We investigate lung perfusion blood flow before and after treatment.
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
| 1 | years-old | <= |
Age-upper limit
| 100 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
We will cover all patients with venous thromboembolism from January to March, Heisei era.
Key exclusion criteria
none
Target sample size
500
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Daisuke Sueta |
Organization
Kumamoto University Hospital
Division name
Cardiovascular Medicine
Zip code
Address
1-1-1 Honjo, Kumamoto
TEL
096-373-5175
sueta-d@kumamoto-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Daisuke Sueta |
Organization
Kumamoto University Hospital
Division name
Cardiovascular Medicine
Zip code
Address
1-1-1 Honjo, Kumamoto
TEL
096-373-5175
Homepage URL
sueta-d@kumamoto-u.ac.jp
Sponsor or person
Institute
Kumamoto University Hospital
Institute
Department
Personal name
Funding Source
Organization
None
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
Address
Tel
Secondary IDs
Secondary IDs
YES
Study ID_1
Senshin 2243
Org. issuing International ID_1
Senshin 2243
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 | 07 | Month | 25 | 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
Open public recruiting
Date of protocol fixation
| 2018 | Year | 07 | Month | 24 | Day |
Date of IRB
Anticipated trial start date
| 2018 | Year | 07 | Month | 24 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
None
Management information
Registered date
| 2018 | Year | 07 | Month | 24 | Day |
Last modified on
| 2018 | Year | 07 | Month | 24 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038199
| Research Plan | |
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| Registered date | File name |
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| Registered date | File name |
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