UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000002689 |
|---|---|
| Receipt number | R000003284 |
| Scientific Title | Evaluation of pulmonary circulation dynamics by using CT perfusion technique. |
| Date of disclosure of the study information | 2009/10/30 |
| Last modified on | 2009/10/29 20:09:28 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Evaluation of pulmonary circulation dynamics by using CT perfusion technique.
Acronym
Evaluation of pulmonary circulation dynamics by using CT perfusion technique.
Scientific Title
Evaluation of pulmonary circulation dynamics by using CT perfusion technique.
Scientific Title:Acronym
Evaluation of pulmonary circulation dynamics by using CT perfusion technique.
Region
| Japan |
Condition
Condition
pulmonary hypertension
Classification by specialty
| Pneumology | Radiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Less invasively evaluating pulmonary circulation dynamics in pulmonary hypertension by using CT perfusion technique.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Correlation between estimated pulmonary arterial pressure by CT perfusion and directly measured pulmonary arterial pressure
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Diagnosis
Type of intervention
| Device,equipment |
Interventions/Control_1
CT perfusion study by contrast enhancement
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
| 15 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patient with pulmonary hypertension or presumed case
Key exclusion criteria
Children younger than 15 years old
Contraindication of contrast enhanced CT such as severe renal dysfunction or history of allergy for contrast agent, etc.
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Fumikazu Sakai |
Organization
Saitama Medical University International Medical Center
Division name
Department of Diagnostic Radiology
Zip code
Address
1397-1, Yamane, Hidaka, Saitama
TEL
042-984-4520
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Takeyuki Watadani |
Organization
Saitama Medical University International Medical Center
Division name
Department of Diagnostic Radiology
Zip code
Address
1397-1, Yamane, Hidaka, Saitama
TEL
042-984-4520
Homepage URL
watadani@saitama-med.ac.jp
Sponsor or person
Institute
Department of Diagnostic Radiology, Saitama Medical University International Medical Center
Institute
Department
Personal name
Funding Source
Organization
Nothing
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
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
埼玉医科大学国際医療センター（埼玉県）
Other administrative information
Date of disclosure of the study information
| 2009 | Year | 10 | Month | 30 | 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
Preinitiation
Date of protocol fixation
| 2009 | Year | 10 | Month | 14 | Day |
Date of IRB
Anticipated trial start date
| 2009 | Year | 11 | Month | 01 | Day |
Last follow-up date
| 2011 | Year | 04 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2009 | Year | 10 | Month | 29 | Day |
Last modified on
| 2009 | Year | 10 | Month | 29 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003284
