UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000050325 |
|---|---|
| Receipt number | R000057126 |
| Scientific Title | Evaluation of aortic atherosclerosis and injuries in patients having the chest and/or back pain using Non-obstructive general angioscopy |
| Date of disclosure of the study information | 2025/04/01 |
| Last modified on | 2023/02/13 19:18:18 |
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Basic information
Public title
Evaluation of aortic atherosclerosis and injuries in patients having the chest and/or back pain using Non-obstructive general angioscopy
Acronym
Evaluation of aortic atherosclerosis and injuries in patients having the chest and/or back pain using angioscopy
Scientific Title
Evaluation of aortic atherosclerosis and injuries in patients having the chest and/or back pain using Non-obstructive general angioscopy
Scientific Title:Acronym
Evaluation of aortic atherosclerosis and injuries in patients having the chest and/or back pain using angioscopy
Region
| Japan |
Condition
Condition
Angina pectus, Atherosclerosis, Aortic injuries
Classification by specialty
| Cardiology | Vascular surgery | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Determine a cause of chest and/or back pain of unknown origin using Non-obstructive general angioscopy.
Basic objectives2
Others
Basic objectives -Others
Evaluate aortic atherosclerosis and injuries in patients having chest and/or back pain of unknown origin using NOGA.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Aortic atherosclerosis and injuries by NOGA.
Key secondary outcomes
Patients' characteristics, cardiovascular risk factors, pain property. Various tests such as blood examinations, physiological examinations, and imaging.
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 having chest and/or back pain from November 1,2015 to March 31, 2024.
Demonstrated unsignificant coronary artery stenosis and other non-cardiac causes.
Key exclusion criteria
Unstable hemodynamics, diagnosed acute aortic syndrome, pregnancy.
Target sample size
70
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
554-0012
Address
Nisikujo 5-4-8, Konohana-ku, Osaka city
TEL
0664620261
satoru_takahashi_hp@yahoo.co.jp
Public contact
Name of contact person
| 1st name | Satoru |
| Middle name | |
| Last name | TakahasTakahashi |
Organization
Osaka Gyoumeikan Hospital
Division name
Cardiovascular Center
Zip code
554-0012
Address
Nisikujo 5-4-8, Konohana-ku, Osaka city
TEL
0664620261
Homepage URL
satoru_takahashi_hp@yahoo.co.jp
Sponsor or person
Institute
Osaka Gyoumeikan Hospital
Institute
Department
Personal name
Funding Source
Organization
None
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
Osaka Gyoumeikan Hospital
Address
Nisikujo 5-4-8, Konohana-ku, Osaka city
Tel
0664620261
t.kawanishi@gyoumeikan.or.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
Other administrative information
Date of disclosure of the study information
| 2025 | Year | 04 | Month | 01 | 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
Open public recruiting
Date of protocol fixation
| 2015 | Year | 11 | Month | 01 | Day |
Date of IRB
| 2023 | Year | 01 | Month | 24 | Day |
Anticipated trial start date
| 2015 | Year | 11 | Month | 01 | Day |
Last follow-up date
| 2024 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
None
Management information
Registered date
| 2023 | Year | 02 | Month | 13 | Day |
Last modified on
| 2023 | Year | 02 | Month | 13 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000057126
