UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000003510 |
|---|---|
| Receipt number | R000004252 |
| Scientific Title | Quantitative coronary optical coherence tomography analysis for signal attenuation and intensity |
| Date of disclosure of the study information | 2010/04/20 |
| Last modified on | 2010/04/20 12:16:09 |
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Basic information
Public title
Quantitative coronary optical coherence tomography analysis for signal attenuation and intensity
Acronym
Quantitative coronary optical coherence tomography analysis
Scientific Title
Quantitative coronary optical coherence tomography analysis for signal attenuation and intensity
Scientific Title:Acronym
Quantitative coronary optical coherence tomography analysis
Region
| Japan |
Condition
Condition
The patients who underwent coronary optical coherence tomography study for the evaluation of restenosis tissue
Classification by specialty
| Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the signal attenuation and intensity of coronary optical coherence tomography image, retrospectively; to compare of the quantitative data with clinical demographics, retrospectively; to study the impact of imaging wire location and the reproducibility of the analysis, retrospectively
Basic objectives2
Others
Basic objectives -Others
To predict the lethal stent thrombosis by means of the quantitative optical coherence tomography analysis for restenosis tissue, subjectively and automatically
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
This study retrospectively compares of the clinical and percutaneous coronary intervention related demographics with the quantitative coronary optical coherence tomography data.
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
The patients who underwent the coronary optical coherence tomography study for the evaluation of in-stent restenosis by November 2009.
Key exclusion criteria
Not applicable
Target sample size
17
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Takaaki Isshiki |
Organization
Teikyo University Hospital
Division name
Division of Cardiology
Zip code
Address
2-11-1, Kaga, Itabashi-ku, Tokyo, Japan
TEL
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name |
Organization
Teikyo University Hospital
Division name
Division of Cardiology
Zip code
Address
TEL
Homepage URL
nsuzu@bronze.ocn.ne.jp
Sponsor or person
Institute
Division of Cardiology, Teikyo University Hospital
Institute
Department
Personal name
Funding Source
Organization
Division of Cardiology, Teikyo University Hospital
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
Other administrative information
Date of disclosure of the study information
| 2010 | Year | 04 | Month | 20 | 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
Completed
Date of protocol fixation
| 2009 | Year | 10 | Month | 31 | Day |
Date of IRB
Anticipated trial start date
| 2009 | Year | 11 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Retrospective, observational trial
Management information
Registered date
| 2010 | Year | 04 | Month | 20 | Day |
Last modified on
| 2010 | Year | 04 | Month | 20 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004252
