UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000034712 |
|---|---|
| Receipt number | R000039579 |
| Scientific Title | Detecting Spontaneous Ruptured Aortic Plaques and Injuries by Non-obstructive General Angioscopy and Safety of Angioscopy |
| Date of disclosure of the study information | 2018/11/30 |
| Last modified on | 2020/11/01 09:44:19 |
* 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
Detecting Spontaneous Ruptured Aortic Plaques and Injuries by Non-obstructive General Angioscopy and Safety of Angioscopy
Acronym
Detecting Spontaneous Ruptured Aortic Plaques and Injuries by Angioscopy
Scientific Title
Detecting Spontaneous Ruptured Aortic Plaques and Injuries by Non-obstructive General Angioscopy and Safety of Angioscopy
Scientific Title:Acronym
Detecting Spontaneous Ruptured Aortic Plaques and Injuries 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 identify and classify the spontaneous ruptured aortic plaques/injuries by non-obstructive general angioscopy (2015.12-2018.8)
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Others
Trial characteristics_2
Others
Developmental phase
Not applicable
Assessment
Primary outcomes
the classification and the incidence of spontaneous ruptured aortic plaques
Key secondary outcomes
change of blood marker and thrombotic symptoms
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
consecutie patients who underwent coronary angioscopy for diagnostic coronary angioscopy or percutaneous coronary intervention.
Key exclusion criteria
acute coronary syndrome, use of intra-aortic balloon pumping or percutaneous cardiopulmonary support, hemodynamic instability (i.e., Killip state >2 or cardiogenic shock), allergy to contrast media, dialysis, and pregnancy.
Target sample size
880
Research contact person
Name of lead principal investigator
| 1st name | Sei |
| Middle name | |
| Last name | Komatsu |
Organization
Osaka Gyoumeikan Hospital
Division name
Cardiovasular Center
Zip code
5540012
Address
5-4-8, Nishi-kujo, Konohana, Osaka
TEL
06-6462-0261
plaquemap@yahoo.co.jp
Public contact
Name of contact person
| 1st name | Sei |
| Middle name | |
| Last name | Komatsu |
Organization
Osaka Gyoumeikan Hospital
Division name
Cardiovasular Center
Zip code
5540012
Address
5-4-8, Nishi-kujo, Konohana, 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
Research Ethics Committee, Osaka Gyoumeikan Hospital
Address
5-4-8, Nishikujo, Osaka
Tel
0664620261
gyoumeikan_hosp_cardiol@yahoo.co.jp
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
Other administrative information
Date of disclosure of the study information
| 2018 | Year | 11 | 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
Completed
Date of protocol fixation
| 2018 | Year | 10 | Month | 31 | Day |
Date of IRB
| 2016 | Year | 07 | Month | 29 | Day |
Anticipated trial start date
| 2018 | Year | 11 | Month | 15 | Day |
Last follow-up date
| 2019 | Year | 10 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
to classify spontaenous ruptured aortic plaques and injuries by non-obstructive general angioscopy and the safety of angioscopy
Management information
Registered date
| 2018 | Year | 10 | Month | 31 | Day |
Last modified on
| 2020 | Year | 11 | Month | 01 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039579
