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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000013299
Receipt No. R000015511
Scientific Title Cerebral blood flow measurement using near infrared spectroscopy in carotid endarterectomy
Date of disclosure of the study information 2014/03/01
Last modified on 2016/06/19

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Basic information
Public title Cerebral blood flow measurement using near infrared spectroscopy in carotid endarterectomy
Acronym Cerebral blood flow measurement using near infrared spectroscopy in carotid endarterectomy
Scientific Title Cerebral blood flow measurement using near infrared spectroscopy in carotid endarterectomy
Scientific Title:Acronym Cerebral blood flow measurement using near infrared spectroscopy in carotid endarterectomy
Region
Japan

Condition
Condition IC stenosis
Classification by specialty
Anesthesiology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To evaluate cerebral blood flow (CBF) during carotid endarterectomy (CEA) is very crucial. However, it is difficult to measure CBF in the operating room. Recently, near-infrared spectroscopy (NIRS) with high accuracy has developed, which enables to measure regional cerebral blood flow by injection of indocyanine green. Kubler et al. reported that regional cerebral blood flow derived from NIRS correlated well with values assessed by radioactive microspheres in pigs. Therefore, we conducted to measure the regional cerebral blood flow derived from NIRS during CEA.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes The impact of the carotid cross clamping on blood flow index was evaluated.
Key secondary outcomes

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 Carotid endarterectomy
Key exclusion criteria Wound in the forehead
Target sample size 50

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Yoshihiko Ohnishi
Organization National cerebral and cardiovascular center
Division name Anesthesiology
Zip code
Address Fujishirodai 5-7-1, Suita, Osaka
TEL 06-6833-5012
Email yonishi@hotmail.co.jp

Public contact
Name of contact person
1st name
Middle name
Last name Shinya Kato
Organization National cerebral and cardiovascular center
Division name Anesthesiology
Zip code
Address Fujishirodai 5-7-1, Suita, Osaka
TEL 06-6833-5012
Homepage URL
Email numberboy1122@yahoo.co.jp

Sponsor
Institute National cerebral and cardiovascular center
Institute
Department

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
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

Other administrative information
Date of disclosure of the study information
2014 Year 03 Month 01 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
Fifty patients were enrolled. The BFI significantly decreased during carotid cross-clamping compared to baseline values . After unclamping the common carotid artery, the BFI recovered to the pre-clamping level. Multiple logistic regression analysis revealed that abnormalities of the circle of Willis correlated significantly with reduced BFI.
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
2012 Year 10 Month 01 Day
Date of IRB
Anticipated trial start date
2012 Year 11 Month 01 Day
Last follow-up date
2015 Year 03 Month 31 Day
Date of closure to data entry
2015 Year 03 Month 31 Day
Date trial data considered complete
2015 Year 03 Month 31 Day
Date analysis concluded
2015 Year 03 Month 31 Day

Other
Other related information The impact of the carotid cross clamping on blood flow index was evaluated in this study.

Management information
Registered date
2014 Year 02 Month 28 Day
Last modified on
2016 Year 06 Month 19 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000015511

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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