UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000046533 |
|---|---|
| Receipt number | R000053095 |
| Scientific Title | Visualization of vascular cross section by application of optical coherence tomography in carotid endarterectomy |
| Date of disclosure of the study information | 2022/01/05 |
| Last modified on | 2022/01/04 14:58:28 |
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Basic information
Public title
Observation of cervical arteriosclerotic lesions by optical coherence tomography
Acronym
Observation of cervical arteriosclerotic lesions by optical coherence tomography
Scientific Title
Visualization of vascular cross section by application of optical coherence tomography in carotid endarterectomy
Scientific Title:Acronym
Visualization of vascular cross section by application of optical coherence tomography in carotid endarterectomy
Region
| Japan |
Condition
Condition
Cervical carotid stenosis
Classification by specialty
| Vascular surgery |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
By applying the optical coherence tomography method used for in vivo evaluation of coronary arteries to carotid endarterectomy, detailed evaluation of carotid arteries and plaques (arteriosclerotic lesions) will be performed in vivo.
Basic objectives2
Others
Basic objectives -Others
To compare with the imaging and pathological findings by observing the cross section of the blood vessel before and after the lesion is removed.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Comparison of findings of optical coherence tomography and pathological findings of atehlosclerosis.
Key secondary outcomes
Comparison of findings of optical coherence tomography and preoperative imaging findings of atehlosclerosis.
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
| 90 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Patient undergoing carotid endarterectomy
Key exclusion criteria
none
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Tsutomu |
| Middle name | |
| Last name | Ichinose |
Organization
Osaka City University
Division name
Neurosurgery
Zip code
545-8585
Address
1-4-3, Asahi-machi, Abeno-ku, Osaka
TEL
0666453846
ichinose-t@med.osaka-cu.ac.jp
Public contact
Name of contact person
| 1st name | Tsutomu |
| Middle name | |
| Last name | Ichinose |
Organization
Osaka City University
Division name
Neurosurgery
Zip code
545-8585
Address
1-4-3, Asahi-machi, Abeno-ku, Osaka
TEL
0666453846
Homepage URL
ichinose-t@med.osaka-cu.ac.jp
Sponsor or person
Institute
Osaka City University
Institute
Department
Personal name
Funding Source
Organization
Japan Science and Technology Agency
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Ethical Committee of Osaka City University Graduate School of Medicine
Address
1-4-3, Asahi-machi, Abeno-ku,Osaka
Tel
06-6645-3456
ethics@med.osaka-cu.ac.jp
Secondary IDs
Secondary IDs
YES
Study ID_1
2021-205
Org. issuing International ID_1
Ethical Committee of Osaka City University Graduate School of Medicine
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2022 | Year | 01 | Month | 05 | 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
Preinitiation
Date of protocol fixation
| 2021 | Year | 12 | Month | 21 | Day |
Date of IRB
| 2021 | Year | 12 | Month | 28 | Day |
Anticipated trial start date
| 2022 | Year | 01 | Month | 05 | Day |
Last follow-up date
| 2026 | 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
| 2022 | Year | 01 | Month | 04 | Day |
Last modified on
| 2022 | Year | 01 | Month | 04 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000053095
