UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000054121 |
|---|---|
| Receipt number | R000061779 |
| Scientific Title | Computed Tomography Perfusion Tissue Time to Maximum Predict Delayed Cerebral Ischemia Following Aneurysmal Subarachnoid Hemorrhage |
| Date of disclosure of the study information | 2024/04/11 |
| Last modified on | 2024/04/11 14:41:54 |
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Basic information
Public title
Computed Tomography Perfusion Tissue Time to Maximum Predict Delayed Cerebral Ischemia Following Aneurysmal Subarachnoid Hemorrhage
Acronym
Computed Tomography Perfusion Tissue Time to Maximum Predict Delayed Cerebral Ischemia Following Aneurysmal Subarachnoid Hemorrhage
Scientific Title
Computed Tomography Perfusion Tissue Time to Maximum Predict Delayed Cerebral Ischemia Following Aneurysmal Subarachnoid Hemorrhage
Scientific Title:Acronym
Computed Tomography Perfusion Tissue Time to Maximum Predict Delayed Cerebral Ischemia Following Aneurysmal Subarachnoid Hemorrhage
Region
| Japan |
Condition
Condition
Subarachnoid hemorrhage
Classification by specialty
| Neurosurgery |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Delayed ischemia is known to occur 3-18 days after the onset of subarachnoid hemorrhage. However, patients with cerebral vasospasm do not always develop delayed ischemia, and although there are various reports on the prediction of delayed ischemia, there is still no biomarker that has achieved a certain level of consensus. Using time-to-maximum analysis by RAPID software with perfusion CT, which has recently attracted attention in the endovascular treatment field, we will search for predictors of delayed cerebral ischemia during cerebral vasospasm after subarachnoid hemorrhage using time-to-maximum analysis and investigate their predictive ability.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
We defined delayed cerebral ischemia as a new cerebral infarction occurring 3-18 days after the onset of subarachnoid hemorrhage. The primary endpoint was the ability of RAPID Software's time to maximam analysis values using perfusion CT performed after 8-12 days of onset to predict the development of delayed cerebral ischemia.
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
All patients with subarachnoid hemorrhage who underwent endovascular treatment or craniotomy at Japanese Red Cross Kumamoto Hospital during the 2-year period from May 12, 2021 to May 11, 2023
Key exclusion criteria
Exclusions were made for individuals with a fifth grade of the World Federation of Neurosurgical Societies (WFNS) Grade and those who had undergone parent artery occlusion, as their inclusion might compromise the accuracy of cerebral perfusion assessment. Within our institution, all patients afflicted with aSAH underwent CT perfusion imaging between days 8 and 12 following the onset of SAH. Following day 14 post-SAH, either CT or MRI was performed, with the date of SAH onset denoted as day 0. Nevertheless, patients who, for any conceivable reason, did not undergo CT perfusion imaging at any point during their clinical trajectory or did not undergo evaluation for DCI, were subject to exclusion.
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | Todaka |
| Middle name | |
| Last name | Tatemi |
Organization
Japanese Red Cross Kumamoto Hospital
Division name
Department of Neurosurgery
Zip code
861-8520
Address
2-1-1 Nagamineminami, Kumamoto City, Kumamoto Prefecture, Japan
TEL
096-384-2111
tsuboki.si@gmail.com
Public contact
Name of contact person
| 1st name | Tsuboki |
| Middle name | |
| Last name | Shimpei |
Organization
Kameda Medical Center
Division name
Department of Neuroendovascular surgery
Zip code
296-8602
Address
929 Higashi-cho, Kamogawa City, Chiba Prefecture, Japan
TEL
04-7092-2211
Homepage URL
si.tsuboki@gmail.com
Sponsor or person
Institute
Japanese Red Cross Kumamoto Hospital
Institute
Department
Personal name
Todaka Tatemi
Funding Source
Organization
Noshing
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
Japanese Red Cross Kumamoto Hospital, Ethical Review Board
Address
2-1-1 Nagamineminami, Kumamoto City, Kumamoto Prefecture, Japan
Tel
096-384-2111
tsuboki.si@gmail.com
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
| 2024 | Year | 04 | 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
58
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
No longer recruiting
Date of protocol fixation
| 2024 | Year | 01 | Month | 29 | Day |
Date of IRB
| 2024 | Year | 03 | Month | 27 | Day |
Anticipated trial start date
| 2024 | Year | 03 | Month | 27 | Day |
Last follow-up date
| 2025 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Retrospective observational analysis
Management information
Registered date
| 2024 | Year | 04 | Month | 11 | Day |
Last modified on
| 2024 | Year | 04 | Month | 11 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000061779
