UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000032938 |
|---|---|
| Receipt number | R000037551 |
| Scientific Title | Usefulness of perfusion measurement using C-arm angiography device in acute stage cerebral infarction |
| Date of disclosure of the study information | 2018/06/11 |
| Last modified on | 2023/06/14 00:53:08 |
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Basic information
Public title
Usefulness of perfusion measurement using C-arm angiography device in acute stage cerebral infarction
Acronym
Usefulness of perfusion measurement using C-arm angiography device in acute stage cerebral infarction
Scientific Title
Usefulness of perfusion measurement using C-arm angiography device in acute stage cerebral infarction
Scientific Title:Acronym
Usefulness of perfusion measurement using C-arm angiography device in acute stage cerebral infarction
Region
| Japan |
Condition
Condition
Acute stage cerebral infarction
Classification by specialty
| Neurosurgery |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Endovascular treatment for acute stage cerebral infarction is performed using a C-arm angiography device in an angiography room. Conventionally, in order to confirm image diagnosis prior to intravascular treatment and confirm the success or failure of treatment, it was necessary for the patient to move from the cerebral vascular treatment room to the examination room etc. and photograph the CT perfusion image or SPECT. The purpose of this study is to verify that it is useful for improving patient prognosis and treatment process by shooting a perfusion image using a C-arm angiography device in intravascular treatment for acute stage cerebral infarction is there.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Main evaluation item MRI image is used as a reference and the C-arm perfusion image is evaluated and the ASPECTS score is compared
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Diagnosis
Type of intervention
| Device,equipment |
Interventions/Control_1
Acquire C arm perfusion image
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 undergo cerebrovascular examination and cerebrovascular treatment depending on medical necessity (2) If consent of participation of research by free will, if not sufficient for consent of the principal or the principal, from the substitute person in writing Patient acquired (3) Age: over 20 years old (4) Gender: no questions (5) different from outpatient outpatient: no question
Key exclusion criteria
(1) Patients with moderate or higher renal dysfunction (eGFR <45 ml / min / 1.73 m 2) (2) Patients who are predictive of allergy by contrast agent (3) Other patients who are deemed inappropriate by a doctor
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Shinichi Yoshimmura |
Organization
Hyogo College of Medicine
Division name
Neurosurgery
Zip code
Address
1-1 Mukogawa, Nishinomiya, Hyogo, Japan
TEL
0798-45-6458
s-yoshi@hyo-med.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Kazutaka Uchida |
Organization
Hyogo College of Medicine
Division name
Neurosurgery
Zip code
Address
1-1 Mukogawa, Nishinomiya, Hyogo, Japan
TEL
0798-45-6458
Homepage URL
kuchidans@yahoo.co.jp
Sponsor or person
Institute
Hyogo College of Medicine
Institute
Department
Personal name
Funding Source
Organization
siemens-healthineers
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
| 2018 | Year | 06 | Month | 11 | 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
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
| 2017 | Year | 05 | Month | 01 | Day |
Date of IRB
| 2017 | Year | 05 | Month | 10 | Day |
Anticipated trial start date
| 2017 | Year | 05 | Month | 30 | Day |
Last follow-up date
| 2021 | Year | 06 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2018 | Year | 06 | Month | 10 | Day |
Last modified on
| 2023 | Year | 06 | Month | 14 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037551
