UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000026820 |
|---|---|
| Receipt number | R000030731 |
| Scientific Title | Measurement of ocular blood flow using by laser speckle flowgraphy as an intraoperative monitoring during carotid endarterectomy |
| Date of disclosure of the study information | 2017/04/01 |
| Last modified on | 2020/10/09 11:52:41 |
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Basic information
Public title
Measurement of ocular blood flow using by laser speckle flowgraphy as an intraoperative monitoring during carotid endarterectomy
Acronym
Ocular LSFG during CEA
Scientific Title
Measurement of ocular blood flow using by laser speckle flowgraphy as an intraoperative monitoring during carotid endarterectomy
Scientific Title:Acronym
Ocular LSFG during CEA
Region
| Japan |
Condition
Condition
carotid artery stenosis
Classification by specialty
| Neurosurgery |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The aim of this study is to compare ocular blood flow by LSFG with preoperative balloon occlusion test for carotid endarterectomy.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
Agreement rate of intraoperative ocular blood flow by LSFG with finding on preoperative BOT
Key secondary outcomes
Agreement rate of intraoperative ocular blood flow by LSFG with intraoperative monitoring including EEG, MEP, SEP, NIRS
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Diagnosis
Type of intervention
| Maneuver |
Interventions/Control_1
medicine)mydriatic
maneuver)measurement of ocular blood flow
timing)during operation
frequency)3 times, before, during, after occlusion of ICA
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
Adult patients undergoing carotid endarterectomy.
Key exclusion criteria
(1)patients with allegy for iodine agent
(2)patients with glaucoma
(3)patients who reject the study
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Yasushi |
| Middle name | |
| Last name | Motoyama |
Organization
Nara Medical University
Division name
Department of Neurosrugery
Zip code
6348522
Address
840 Shijo-cho Kashihara city, Nara, Japan
TEL
0744298866
myasushi@naramed-u.ac.jp
Public contact
Name of contact person
| 1st name | Yasushi |
| Middle name | |
| Last name | Motoyama |
Organization
Nara Medical University
Division name
Department of Neurosrugery
Zip code
6348522
Address
840 Shijo-cho Kashihara city, Nara, Japan
TEL
0744298866
Homepage URL
myasushi@naramed-u.ac.jp
Sponsor or person
Institute
Department of Neurosurgery, Nara Medical University
Institute
Department
Personal name
Funding Source
Organization
Department of Neurosurgery, Nara Medical University
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
Nara Medical University
Address
840 Shijo-cho
Tel
+81744298866
myasushi@naramed-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
奈良県立医科大学付属病院
Other administrative information
Date of disclosure of the study information
| 2017 | Year | 04 | Month | 01 | Day |
Related information
URL releasing protocol
https://naraidai-neuro.jp/kenkyu/
Publication of results
Unpublished
Result
URL related to results and publications
https://link.springer.com/article/10.1007%2Fs10877-020-00475-1
Number of participants that the trial has enrolled
19
Results
The MBR reduction ratio between before and after carotid clamping ranged from -12 to 100%. The MBR reduction ratio was positively correlated with the rSO2 index (r=0.694, 95%CI: 0.336-0.877, p=0.001).
Results date posted
| 2020 | Year | 10 | Month | 09 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Nineteen patients undergoing CEA with ocular blood flow measurement by LSFG and intraoperative monitoring (IOM) were prospectively enrolled between August 2016 and March 2019. The mean blur rate (MBR) of ocular blood flow by LSFG, representing relative blood flow of the branch of the retinal artery originating from the optic nerve head, was compared between before and after carotid clamping during CEA.
Participant flow
During CEA, ocular blood flow was measured by LSFG 5 times. First, before the start of the operation, measurement of ocular blood flow by LSFG was performed as a control when the patient was placed on the operating table and the head was fixed by the skull clamp. After exposure of the carotid artery, ocular blood flow was measured by LSFG before carotid clamping as a baseline. Then, after carotid clamping, ocular blood flow was measured by LSFG to calculate the reduction ratio. After release of carotid clamping, followed by completed plaque removal and angiorrhaphy, ocular blood flow was measured by LSFG to confirm that blood flow of the carotid artery had restarted. Finally, ocular blood flow measured by LSFG was recorded at the end of surgery.
When an internal shunt was placed, measurement of ocular blood flow by LSFG was performed 7 times, by adding after insertion and then after removal of the internal shunt. The success rate of measurement of ocular blood flow by LSFG was calculated based on the number of successes divided by the total number of sessions.
Adverse events
none
Outcome measures
The MBR reduction ratio of ocular blood flow by LSFG after carotid clamping was significantly correlated with the rSO2 index. The ocular blood flow by LSFG could be considered an adjunct modality for evaluating cerebral ischemic tolerance during CEA.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2017 | Year | 03 | Month | 30 | Day |
Date of IRB
| 2017 | Year | 03 | Month | 30 | Day |
Anticipated trial start date
| 2017 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2019 | Year | 04 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2017 | Year | 04 | Month | 01 | Day |
Last modified on
| 2020 | Year | 10 | Month | 09 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030731
