UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000000490 |
|---|---|
| Receipt number | R000000071 |
| Scientific Title | Patients' entrance skin doses during percutaneous coronary intervention for chronic total occlusion |
| Date of disclosure of the study information | 2007/12/01 |
| Last modified on | 2009/09/17 17:08:24 |
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Basic information
Public title
Patients' entrance skin doses during percutaneous coronary intervention for chronic total occlusion
Acronym
ESD during PCI for CTO
Scientific Title
Patients' entrance skin doses during percutaneous coronary intervention for chronic total occlusion
Scientific Title:Acronym
ESD during PCI for CTO
Region
| Japan |
Condition
Condition
chronic total occlusion
Classification by specialty
| Cardiology | Dermatology | Radiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate patients' entrance skin doses during percutaneous coronary intervention for chronic total occlusion
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
patients' entrans skin dose
Key secondary outcomes
data of PCI, radiation induced skin injury
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients must be scheduled for PCI for CTO based on clinical indication
Key exclusion criteria
1. Patients scheduled for PCI, in which the upper arm may included in the irradiation field
2. Patient with skin lesion on the back which can be confused with radiation induced skin injury before the PCI procedure
3. Inability to sit before PCI prpcedure
4. Functional CTO
Target sample size
120
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Shigeru Furui |
Organization
Teikyo University school of Medicine
Division name
Department of Radiology
Zip code
Address
2-11-1, Kaga, Itabashi-ku, Tokyo 173-8605, Japan
TEL
03-3964-1211
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Shigeru Suzuki |
Organization
Teikyo University school of Medicine
Division name
Department of Radiology
Zip code
Address
2-11-1, Kaga, Itabashi-ku, Tokyo 173-8605, Japan
TEL
03-3964-1211
Homepage URL
s-suzuki@med.teikyo-u.ac.jp
Sponsor or person
Institute
Radiological Protection During PCI Conference
Institute
Department
Personal name
Funding Source
Organization
Ministry of Education, Culture, Sports, Science and Technology
Organization
Division
Category of Funding Organization
Nationality of Funding Organization
Japan
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
| 2007 | Year | 12 | Month | 01 | 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
The total fluoroscopic time was 45.0 +- 24.5 minutes (range: 10.3 - 113.0 minutes), and the total number of cine frames was 4558 +- 3440 (range: 855 - 22950). The maximum ESD for each patient was 3.2 +- 2.1 Gy (range: 0.5 - 10.2 Gy, median: 2.7 Gy).
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
| 2005 | Year | 08 | Month | 25 | Day |
Date of IRB
Anticipated trial start date
| 2005 | Year | 09 | Month | 01 | Day |
Last follow-up date
| 2007 | Year | 03 | Month | 01 | Day |
Date of closure to data entry
| 2007 | Year | 05 | Month | 01 | Day |
Date trial data considered complete
| 2007 | Year | 07 | Month | 01 | Day |
Date analysis concluded
| 2007 | Year | 10 | Month | 01 | Day |
Other
Other related information
retrospective study
Management information
Registered date
| 2006 | Year | 09 | Month | 15 | Day |
Last modified on
| 2009 | Year | 09 | Month | 17 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000071
