UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000050312 |
|---|---|
| Receipt number | R000054415 |
| Scientific Title | Association between changes in intracranial blood flow and higher brain function before and after carotid endarterectomy |
| Date of disclosure of the study information | 2023/02/12 |
| Last modified on | 2023/02/12 11:21:16 |
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Basic information
Public title
Association between cerebral blood flow and cognitive function in carotid endarterectomy
Acronym
Association between cerebral blood flow and cognitive function in carotid endarterectomy
Scientific Title
Association between changes in intracranial blood flow and higher brain function before and after carotid endarterectomy
Scientific Title:Acronym
Association between changes in intracranial blood flow and higher brain function before and after carotid endarterectomy
Region
| Japan |
Condition
Condition
carotid artery stenosis
Classification by specialty
| Neurosurgery |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The effects of carotid endarterectomy on postoperative cognitive function have yet to be controversial. In this study, near-infrared spectroscopy was performed before and after surgery to investigate the relationship between the blood flow pattern in the cerebral cortex and changes in cognitive function.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Changes in Mini-Mental state Examination (MMSE) score between before and 6-month after carotid endarterectomy surgery
Key secondary outcomes
Changes in Frontal Assessment Battery at bedside (FAB) score between before and 6-month after carotid endarterectomy surgery
Changes in measurement value of near-infrared spectroscopy between before and 6-month after carotid endarterectomy surgery
Changes of cerebral blood flow at rest between before and 6-month after carotid endarterectomy surgery
Preoperative factors affecting MMSE score improvement from preoperative to 6 months
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
| Device,equipment |
Interventions/Control_1
near-infrared spectroscopy
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
Grade 1 or lower on the preoperative modified Rankin Scale (mRS)
At least 1 month had passed from the last stroke or transient ischemic attack to carotid endarterectomy in the symptomatic case
Key exclusion criteria
Aphasia, apraxia, or agnosia
Psychiatric diseases except mild cognitive impairment
History of revascularization procedures including carotid endarterectomy
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Shunpei |
| Middle name | |
| Last name | Andoh |
Organization
Department of Neurosurgery (Omori), School of Medicine, Faculty of Medicine, Toho University
Division name
Neurosurgery
Zip code
143-8541
Address
6-11-1, Omori-nishi, Ota-ku, Tokyo
TEL
03-3762-4151
s.andoh.ns@gmail.com
Public contact
Name of contact person
| 1st name | Shunpei |
| Middle name | |
| Last name | Andoh |
Organization
Department of Neurosurgery (Omori), School of Medicine, Faculty of Medicine, Toho University
Division name
Neurosurgery
Zip code
143-8541
Address
6-11-1, Omori-nishi, Ota-ku, Tokyo
TEL
03-3762-4151
Homepage URL
s.andoh.ns@gmail.com
Sponsor or person
Institute
Toho University
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
Medical research ethics committee, Toho university faculty of medicine
Address
5-21-16, Omori-nishi, Ota-ku, Tokyo
Tel
03-3762-4151(ext.2455)
med.rinri@ext.toho-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
| 2023 | Year | 02 | Month | 12 | Day |
Related information
URL releasing protocol
Protocol is not available to the public and there is no URL.
Publication of results
Unpublished
Result
URL related to results and publications
Results are not available to the public and there is no URL.
Number of participants that the trial has enrolled
20
Results
Significant improvement in postoperative MMSE score was observed at 6 months in all patients and at 3 and 6 months in the mild cognitive impairment group (group M). SPECT and NIRS showed no significant changes. Preoperative factors affecting MMSE score improvement from preoperative to 6 months were examined: in Group M, multivariate analysis in the backward selection method revealed statistically significant differences in preoperative MMSE score and preoperative frontal centroid and slope.
Results date posted
| 2023 | Year | 02 | Month | 12 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
The mean age of all patients was 72.8 years, and all were male. There were no complications such as symptomatic cerebral infarction, hyperperfusion syndrome, or cerebral hemorrhage. The 12 patients in Group M were significantly older than the 8 patients in the cognitively normal group　(Group N) (p=0.03). No significant differences were noted in stenosis rate, percentage of symptomatic cases, or years of education between the two groups.
Participant flow
Between March 2018 and February 2020, 32 consecutive carotid endarterectomy were performed at the Department of Neurosurgery, Toho University Medical Center Omori Hospital. Of these, 20 cases that met the inclusion criteria were prospectively reviewed.
Adverse events
none
Outcome measures
In all 20 patients, the preoperative MMSE was 26.9 points. The postoperative score was 27.9 at 6 months. A significant improvement was noted in scores from preoperative to 6 months (p=0.0409). In Group M, the preoperative MMSE was 25.3 points. The postoperative scores was 27.0 at 6 months. There was a significant improvement in scores from preoperative to 6 months (p=0.0166). In contrast, no significant difference was noted in MMSE scores between the preoperative and postoperative periods in Group N.
In all 20 patients, the preoperative Frontal Assessment Battery at bedside (FAB) score was 15.8 points. The postoperative score was 16.7 points at 6 months. A significant improvement was noted from the preoperative to 6 months (p=0.0099). In Group M, the preoperative FAB was 15.3 points. The postoperative score was 16.2 points at 6 months. A significant improvement was noted in scores from preoperative to 6 months postoperative (p=0.0357). In contrast, there was no change in FAB between the preoperative and postoperative periods in Group N.
The resting cerebral blood flow in the operative hemisphere, ACA, and MCA region was examined. No significant changes were noted in resting cerebral blood flow before and after surgery, and the same was true for Groups M and N.
Changes over time in integral, centroid, and slope were examined in all near-infrared spectroscopy (NIRS) channels, the operative channel, the operative frontal channel, and the operative temporal channel. The results showed no significant changes from preoperative to 6 months postoperative in all cases, in both Group M and Group N.
In Group M, univariate analysis was performed using the change in MMSE scores preoperatively and 6 months postoperatively as the dependent variable. The results showed that no significant preoperative factors were involved. Multivariate analysis in the backward selection method revealed statistically significant differences in preoperative MMSE scores and preoperative frontal centroid and slope (p=0.0229, p=0.0268, p=0.0085, respectively). A positive correlation was found between the MMSE score change at 6 months postoperatively and the multiple regression equation obtained from the preoperative MMSE, the preoperative centroid and slope value in the frontal region. The correlation coefficient R was as high as 0.81 (p=0.0013).
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2017 | Year | 09 | Month | 01 | Day |
Date of IRB
| 2017 | Year | 09 | Month | 06 | Day |
Anticipated trial start date
| 2018 | Year | 03 | Month | 01 | Day |
Last follow-up date
| 2020 | Year | 08 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2023 | Year | 02 | Month | 12 | Day |
Last modified on
| 2023 | Year | 02 | Month | 12 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000054415
