UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000042178 |
|---|---|
| Receipt number | R000048145 |
| Scientific Title | Detecting Vessel Abnormality such as Aortic Plaques and Injuries by Non-Obstructive General Angioscopy Having or Suspected coronary Artery Disease |
| Date of disclosure of the study information | 2022/10/30 |
| Last modified on | 2020/10/20 15:32:48 |
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Basic information
Public title
Detecting Vessel Abnormality such as Aortic Plaques and Injuries by Non-Obstructive General Angioscopy Having or Suspected coronary Artery Disease
Acronym
Detecting Vessel Abnormality such as Aortic Plaques and Injuries by Non-Obstructive General Angioscopy
Scientific Title
Detecting Vessel Abnormality such as Aortic Plaques and Injuries by Non-Obstructive General Angioscopy Having or Suspected coronary Artery Disease
Scientific Title:Acronym
Detecting Vessel Abnormality by Non-Obstructive General Angioscopy
Region
| Japan |
Condition
Condition
Vessel abnormality (Aorta, venous system)
Classification by specialty
| Cardiology | Vascular surgery |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To detect vessel abnormality such as aortic plaques and injuries, to evaluate the incidence and character and examine the relationship between aortic, coronary , and embolic disease
Basic objectives2
Others
Basic objectives -Others
observational, cross-sectional
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
embolic disease and rupturing aortic disease
Key secondary outcomes
The incidence of location, the inflammatory level, and the degree of plaques by non-obstructive general angioscopy, heart failure
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
patients who undergo cardiovascular catheter such as coronary artery, aorta and vein
Key exclusion criteria
cardiogenic shock without hemodynamic support, aortic disease which needed emergent operation, allergy to contrast media, and pregnancy
Target sample size
1500
Research contact person
Name of lead principal investigator
| 1st name | Sei |
| Middle name | |
| Last name | Komatsu |
Organization
Osaka Gyoumeikan Hospital
Division name
Cardiovascular Center
Zip code
5540012
Address
5-4-8, Nishikujo, Konohana, Japan
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
Cardiovascular Center
Zip code
554-0012
Address
5-4-8, nishi-kujo, Konohana, Osaka
TEL
06-6462-0261
Homepage URL
plaquemap@yahoo.co.jp
Sponsor or person
Institute
Cardiovascular Center, 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
Osaka Gyoumeikan Hospital
Address
5-4-8, Nishikujo, Osaka
Tel
06-6462-0261
plaquemap@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（大阪府）
Other administrative information
Date of disclosure of the study information
| 2022 | Year | 10 | 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
Enrolling by invitation
Date of protocol fixation
| 2017 | Year | 04 | Month | 26 | Day |
Date of IRB
| 2017 | Year | 04 | Month | 28 | Day |
Anticipated trial start date
| 2017 | Year | 05 | Month | 01 | Day |
Last follow-up date
| 2022 | Year | 04 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Characteristics of Vessels such as aortic and coronary injuries and venous system are compared among biomarkers, pathological ways and clinical characteristics.
Management information
Registered date
| 2020 | Year | 10 | Month | 20 | Day |
Last modified on
| 2020 | Year | 10 | Month | 20 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000048145
