UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000007999 |
|---|---|
| Receipt number | R000009343 |
| Scientific Title | Role of CT and SPECT in the assessment of therapeutic effect of anticoagulation or thrombolytic therapy for pulmonary thromboemboslism |
| Date of disclosure of the study information | 2012/06/01 |
| Last modified on | 2015/05/21 09:23:36 |
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Basic information
Public title
Role of CT and SPECT in the assessment of therapeutic effect of anticoagulation or thrombolytic therapy for pulmonary thromboemboslism
Acronym
ROL of CT and SPECT in the PTE
Scientific Title
Role of CT and SPECT in the assessment of therapeutic effect of anticoagulation or thrombolytic therapy for pulmonary thromboemboslism
Scientific Title:Acronym
ROL of CT and SPECT in the PTE
Region
| Japan |
Condition
Condition
pulmonary thromboembolism
Classification by specialty
| Pneumology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To assess the frequncy of natural history and transition from acute to chronic pulmonary thromboembolism in a theree-year period.
Basic objectives2
Others
Basic objectives -Others
none
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Transition of acute pulmonary thromboembolism to chronic thromboembolic pulmonary hypertension
Key secondary outcomes
Findings of CT pulmonary angiography and SPECT
RV dimension, RV dyssynergy and estimated PA pressure on cardica US
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Diagnosis
Type of intervention
| Other |
Interventions/Control_1
CT pulmonary agngiography
CT venography
lung perfusin SPECT
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients diagnosed as acute pulmonary thromboembolism with CT paulmonary angiographt
Key exclusion criteria
Past history of pulmonary thromboembolsim
Target sample size
36
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Shigeru Kosuda |
Organization
Self Defence Meidical School
Division name
Department of Radiology
Zip code
Address
Namiki 1-1, Tokorozawa, Saitama
TEL
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name |
Organization
Self Defence Meidical School
Division name
Department of Radiology
Zip code
Address
Namiki 1-1, Tokorozawa, Saitama
TEL
Homepage URL
Sponsor or person
Institute
Postgraduate School, Saitama Meidcal University
Institute
Department
Personal name
Funding Source
Organization
Postgraduate School, Saitama Meidcal University
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
埼玉医科大学死総合医療センター放射線科、心臓内科、呼吸器内科、呼吸器外科（埼玉県）
Other administrative information
Date of disclosure of the study information
| 2012 | Year | 06 | Month | 01 | 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
| 2012 | Year | 05 | Month | 16 | Day |
Date of IRB
Anticipated trial start date
| 2012 | Year | 08 | Month | 01 | Day |
Last follow-up date
| 2016 | Year | 08 | Month | 01 | Day |
Date of closure to data entry
| 2016 | Year | 09 | Month | 01 | Day |
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2012 | Year | 05 | Month | 21 | Day |
Last modified on
| 2015 | Year | 05 | Month | 21 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000009343
