UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000013299 |
|---|---|
| Receipt number | 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 10:05:04 |
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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
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
numberboy1122@yahoo.co.jp
Sponsor or person
Institute
National cerebral and cardiovascular center
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
Address
Tel
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000015511
