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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000046533
Receipt No. 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

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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
Email 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
Email ichinose-t@med.osaka-cu.ac.jp

Sponsor
Institute Osaka City University
Institute
Department

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
Email 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
URL(English) https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000053095

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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