UMIN-ICDS 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

carotid artery stenosis

Classification by specialty

Neurosurgery

Classification by malignancy

Others

Genomic information

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

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

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

Email

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

Email

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)

Email

med.rinri@ext.toho-u.ac.jp

Secondary IDs

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

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

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/icdr_e/ctr_view.cgi?recptno=R000054415

Research Plan
Registered date	File name

Research case data specifications
Registered date	File name

Research case data
Registered date	File name