UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000029772 |
|---|---|
| Receipt number | R000034016 |
| Scientific Title | Detecting Ruptured Aortic Plaques by Non-obstructive angioscopy |
| Date of disclosure of the study information | 2017/11/03 |
| Last modified on | 2017/11/23 21:00:59 |
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Basic information
Public title
Detecting Ruptured Aortic Plaques by Non-obstructive angioscopy
Acronym
Detecting Ruptured Aortic Plaques by angioscopy
Scientific Title
Detecting Ruptured Aortic Plaques by Non-obstructive angioscopy
Scientific Title:Acronym
Detecting Ruptured Aortic Plaques by angioscopy
Region
| Japan |
Condition
Condition
coronary heart disease or suspected
Classification by specialty
| Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To clarify the ruptured aortic plaques by non-obstructive angioscopy (2015.10-2017.9)
Basic objectives2
Others
Basic objectives -Others
cross-sectional, observational study
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
the incidence and pathologic classification of ruptured aortic plaque
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
consecutive patients who underwent coronary angioscopy for diagnosic coronary angioscopy or percutaneous coronary intervention.
Key exclusion criteria
acute coronary syndrome, use of intra-aortic balloon pumping or percutaneous cardiopulmonary support, hemodynamic instability, aortic dissection, aortic aneurysm larger than the size indicated for surgery, allergy to contrast media, and pregnancy.
Target sample size
324
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Sei Komatsu, MD, PhD |
Organization
Osaka Gyoumeikan Hospital
Division name
Cardiovascular Center
Zip code
Address
5-4-8, Nishi-Kujo, Konohana, Osaka
TEL
06-6462-0261
plaquemap@yahoo.co.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Sei Komatsu, MD, PhD |
Organization
Osaka Gyoumeikan Hospital
Division name
Cardiovascular Center
Zip code
Address
5-4-8, Nishi-Kujo, Konohana, 554-0012, Osaka
TEL
06-6462-0261
Homepage URL
plaquemap@yahoo.co.jp
Sponsor or person
Institute
Osaka Gyoumeikan Hospital
Institute
Department
Personal name
Funding Source
Organization
Osaka Gyoumeikan Hospital
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
大阪暁明館病院（大阪府）
Other administrative information
Date of disclosure of the study information
| 2017 | Year | 11 | Month | 03 | 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
The sizes of aortic plaque rupture were smaller than thought.
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
| 2007 | Year | 10 | Month | 31 | Day |
Date of IRB
Anticipated trial start date
| 2017 | Year | 10 | Month | 31 | Day |
Last follow-up date
| 2017 | Year | 11 | Month | 19 | Day |
Date of closure to data entry
| 2017 | Year | 11 | Month | 19 | Day |
Date trial data considered complete
| 2017 | Year | 11 | Month | 19 | Day |
Date analysis concluded
| 2017 | Year | 11 | Month | 19 | Day |
Other
Other related information
to identify the incidence of aortic plaque rupture, and to measure the sizes of aortic plaque rupture by direct sampling using non-obstructive angioscopy system
Management information
Registered date
| 2017 | Year | 10 | Month | 31 | Day |
Last modified on
| 2017 | Year | 11 | Month | 23 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034016
