UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000063618 |
|---|---|
| Receipt number | R000072710 |
| Scientific Title | REtinal imaging as a WiNDow into carotid stenosis and ischemic stroke |
| Date of disclosure of the study information | 2026/11/13 |
| Last modified on | 2026/11/13 10:20:23 |
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Basic information
Public title
REtinal imaging as a WiNDow into carotid stenosis and ischemic stroke
Acronym
ReWiND study
Scientific Title
REtinal imaging as a WiNDow into carotid stenosis and ischemic stroke
Scientific Title:Acronym
ReWiND study
Region
| Japan |
Condition
Condition
Carotid stenosis and ischemic stroke
Classification by specialty
| Neurology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This study aims to assess retinal imaging findings using techniques such as OCT, OCTA, and LSFG in patients with carotid stenosis or ischemic stroke, and to investigate the associations between these findings and carotid artery stenosis and ischemic stroke subtypes.
Basic objectives2
Others
Basic objectives -Others
An observational study investigating the associations of retinal imaging findings with carotid artery stenosis and ischemic stroke.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Association between characteristics of carotid artery stenosis and retinal imaging findings.
Key secondary outcomes
1. Association between retinal imaging findings and ischemic stroke subtypes.
2. Associations between retinal imaging findings and clinical characteristics, such as hypertension, diabetes mellitus, dyslipidemia, and atrial fibrillation.
3. Association of retinal imaging findings with the occurrence of ischemic stroke or TIA during follow-up.
4. Association between laboratory parameters and retinal imaging findings.
5. Association between retinal imaging findings and findings on carotid ultrasonography and echocardiography.
6. Association of retinal imaging findings with brain, carotid, and cardiac MRI findings.
7. Changes in retinal imaging findings before and after carotid artery stenting.
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Participants with carotid artery stenosis detected by carotid ultrasonography or a history of ischemic stroke.
Key exclusion criteria
1. Ocular diseases, such as macular or retinal diseases, that make it difficult to acquire or assess retinal images.
2. Use of mydriatic agents deemed inappropriate based on ophthalmologic examination findings, such as glaucoma or narrow anterior chamber angles.
3. History of carotid artery stenting or carotid endarterectomy before enrollment.
4. Contraindication to MRI or inability to undergo MRI.
Target sample size
300
Research contact person
Name of lead principal investigator
| 1st name | Junji |
| Middle name | |
| Last name | Takasugi |
Organization
The University of Osaka Graduate School of Medicine
Division name
Departmen of Neurology
Zip code
565-0871
Address
2-2, Yamadaoka, Suita City, Osaka, Japan
TEL
06-6879-3571
takasugi@neurol.med.osaka-u.ac.jp
Public contact
Name of contact person
| 1st name | Junji |
| Middle name | |
| Last name | Takasugi |
Organization
The University of Osaka Graduate School of Medicine
Division name
Department of Neurology
Zip code
565-0871
Address
2-2, Yamadaoka, Suita City, Osaka, Japan
TEL
06-6879-3571
Homepage URL
takasugi@neurol.med.osaka-u.ac.jp
Sponsor or person
Institute
The University of Osaka Graduate School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Daiwa Securities Foundation
Organization
Division
Category of Funding Organization
Non profit foundation
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
The University of Osaka Hospital Ethical Review Board
Address
2-2, Yamadaoka, Suita-city, Osaka
Tel
06-6210-8296
rinri@hp-crc.med.osaka-u.ac.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
| 2026 | Year | 11 | Month | 13 | 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
| 2026 | Year | 10 | Month | 26 | Day |
Date of IRB
| 2026 | Year | 11 | Month | 13 | Day |
Anticipated trial start date
| 2026 | Year | 12 | Month | 01 | Day |
Last follow-up date
| 2033 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
A prospective, single-center observational study
Management information
Registered date
| 2026 | Year | 11 | Month | 13 | Day |
Last modified on
| 2026 | Year | 11 | Month | 13 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000072710
