UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000020045
Receipt number R000023149
Scientific Title A prospective study for impact of the carotid artery stenting on cognitive function in patients with extracranial carotid artery stenosis.
Date of disclosure of the study information 2015/12/04
Last modified on 2018/02/14 11:22:05

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Basic information

Public title

A prospective study for impact of the carotid artery stenting on cognitive function in patients with extracranial carotid artery stenosis.

Acronym

A prospective study for impact of the carotid artery stenting on cognitive function in patients with extracranial carotid artery stenosis.

Scientific Title

A prospective study for impact of the carotid artery stenting on cognitive function in patients with extracranial carotid artery stenosis.

Scientific Title:Acronym

A prospective study for impact of the carotid artery stenting on cognitive function in patients with extracranial carotid artery stenosis.

Region

Japan


Condition

Condition

Extracranial carotid artery stenosis

Classification by specialty

Neurology Neurosurgery

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

In some cases, cognitive function improves after carotid artery stenting in patients with carotid artery stenosis. The aim of this study is to figure out predictors of postoperative cognitive function from preoperative functional connectivity analysis of the brain network and regional cerebral blood flow study.

Basic objectives2

Others

Basic objectives -Others

Basic objectives are to understand the mechanisms of the of cognitive function improvement following carotid artery stenting, and to establish biomarkers which can predict the cognitive function after carotid artery stenting based on preoperative functional connectivity analysis of brain network and regional cerebral blood flow study.

Trial characteristics_1

Exploratory

Trial characteristics_2

Explanatory

Developmental phase

Not applicable


Assessment

Primary outcomes

Improvement of cognitive function after carotid artery stenting

Key secondary outcomes

1)Alteration of functional connectivity
2)Alteration of regional cerebral blood flow


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


Not applicable

Gender

Male and Female

Key inclusion criteria

1) Patients who are scheduled for carotid artery stenting

2) Patients who have agreed to participate in this study with an informed consent.

Key exclusion criteria

1) Patients judged not to be eligible by the primary doctor
2) Any other disease which can affect patient's cognitive function

Target sample size

40


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Naoki Tani

Organization

Osaka General Medical Center

Division name

Department of Neurosurgery

Zip code


Address

Sumiyoshi-ku Mandai Higashi 3-1-56, Osaka city, Osaka, Japan

TEL

06-6692-1201

Email

n-tani@gh.opho.jp


Public contact

Name of contact person

1st name
Middle name
Last name Naoki Tani

Organization

Osaka General Medical Center

Division name

Department of Neurosurgery

Zip code


Address

Sumiyoshi-ku Mandai Higashi 3-1-56, Osaka city, Osaka, Japan

TEL

06-6692-1201

Homepage URL


Email

n-tani@gh.opho.jp


Sponsor or person

Institute

Osaka General Medical Center

Institute

Department

Personal name



Funding Source

Organization

Mitsui Life Social Welfare Foundation

Organization

Division

Category of Funding Organization

Non profit foundation

Nationality of Funding Organization

Japan


Other related organizations

Co-sponsor

Hanwa Memorial Hospital

Name of secondary funder(s)



IRB Contact (For public release)

Organization


Address


Tel


Email



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

大阪府立急性期総合医療センター (大阪府)、阪和記念病院 (大阪府)


Other administrative information

Date of disclosure of the study information

2015 Year 12 Month 04 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

Post-CAS cognitive function varied between patients and between categories of neuropsychological tests. Although there was no significant overall improvement in working memory scores after CAS, post-CAS working memory scores changed in negative correlation with changes in FC of the DMN between the precentral/superior frontal gyrus and middle frontal gyrus. In addition, FC of the DMN between the preoperative precentral/superior frontal gyrus and medial frontal gyrus correlated positively with the post-CAS improvement in working memory.

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

Completed

Date of protocol fixation

2015 Year 09 Month 10 Day

Date of IRB


Anticipated trial start date

2015 Year 12 Month 04 Day

Last follow-up date

2017 Year 12 Month 31 Day

Date of closure to data entry

2017 Year 12 Month 31 Day

Date trial data considered complete

2017 Year 12 Month 31 Day

Date analysis concluded

2018 Year 02 Month 14 Day


Other

Other related information

This is a prospective cohort study. Participants have already been indicated for carotid artery stenting (CAS) in Osaka General Medical Center or Hanwa Memorial Hospital independently of this study from December 2015 to March 2017 (all participants will receive standard CAS in clinical settings provided by their attending neurosurgeons. The informed consent for CAS have already been obtained before recruitment independently of the study).
Participants are required to meet the inclusion criteria (1.Patients that are scheduled for carotid artery stenting. 2.The patients who have agreed to participate in this study with an informed consent.) and are required not to meet the exclusion criteria (1. Patients judged not to be eligible by the principal investigator. 2.Any other disease that can affect patient's cognitive function.)

Participants will undergo cognitive assessment (WMS-R, WAIS-III), MRI and cerebral blood flow assessment (SPECT) before and after CAS.
For control group, we will include age- and gender-matched healthy controls.


Management information

Registered date

2015 Year 12 Month 03 Day

Last modified on

2018 Year 02 Month 14 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000023149


Research Plan
Registered date File name
2018/02/14 介入研究計画書_CASと高次脳機能 .doc

Research case data specifications
Registered date File name

Research case data
Registered date File name