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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000000490
Receipt No. 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

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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
Email

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
Email s-suzuki@med.teikyo-u.ac.jp

Sponsor
Institute Radiological Protection During PCI Conference
Institute
Department

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
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000071

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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