UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000039046 |
|---|---|
| Receipt number | R000044527 |
| Scientific Title | Observational study for ischemic penumbra using advanced MRI technology |
| Date of disclosure of the study information | 2020/03/01 |
| Last modified on | 2023/07/07 11:16:22 |
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Basic information
Public title
Observational study for ischemic penumbra using advanced MRI technology
Acronym
Ischemic penumbra imaging
Scientific Title
Observational study for ischemic penumbra using advanced MRI technology
Scientific Title:Acronym
Ischemic penumbra imaging
Region
| Japan |
Condition
Condition
Acute ischemic stroke
Classification by specialty
| Neurology | Neurosurgery | Emergency medicine |
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To assess lesion of ischemic penumbra using quantitative susceptibility mapping
Basic objectives2
Others
Basic objectives -Others
Property of ischemic penumbra using advanced MRI technology
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Correlation of quantitative susceptibility mapping with dynamic susceptibility contrast-derived ischemic penumbra tissues
Key secondary outcomes
Correlation of quantitative susceptibility mapping with National Institutes of Health Stroke Scale scores scores
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
| 90 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Patients with acute stroke diagnosed by MRI
Key exclusion criteria
Contraindication for MRI
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | Yuto |
| Middle name | |
| Last name | Uchida |
Organization
Toyokawa City Hospital
Division name
Neurology
Zip code
442-0857
Address
23 Noji, Yawata, Toyokawa, Aichi
TEL
0533-86-1111
uchidayuto0720@yahoo.co.jp
Public contact
Name of contact person
| 1st name | Shinobu |
| Middle name | |
| Last name | Kito |
Organization
Toyokawa City Hospital
Division name
Institutional Review Board
Zip code
467-8601
Address
23 Noji, Yawata, Toyokawa, Aichi
TEL
0533-86-1111
Homepage URL
kitomrn@toyokawa-ch-aichi.jp
Sponsor or person
Institute
Toyokawa City Hospital
Institute
Department
Personal name
Funding Source
Organization
Toyokawa City Hospital
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
Toyokawa City Hospital
Address
23 Noji, Yawata, Toyokawa, Aichi
Tel
0533-86-1111
kitomrn@toyokawa-ch-aichi.jp
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
| 2020 | Year | 03 | Month | 01 | Day |
Related information
URL releasing protocol
doi: 10.3389/fneur.2022.752450
Publication of results
Partially published
Result
URL related to results and publications
doi: 10.3389/fneur.2022.752450
Number of participants that the trial has enrolled
21
Results
In these patients, the volumes with increased OEF values of>51.5%, which was defined using the anterior circulation territory OEF values from the 21 healthy controls, were positively correlated with the ischemic penumbra volumes and inversely correlated with the 30-day change in the National Institutes of Health Stroke Scale scores.
Results date posted
| 2023 | Year | 07 | Month | 07 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
This prospective imaging study included 21 patients with
large anterior circulation vessel occlusion who were admitted <24 h after stroke onset
and 21 age-matched healthy controls.
Participant flow
We identified the ischemic penumbra as the region
with a Tmax of>6 s during dynamic susceptibility contrast-magnetic resonance imaging
(DSC-MRI) and calculated the perfusion-core mismatch ratio between the ischemic
penumbra and infarct core volumes. The OEF values were measured based on magnetic
susceptibility differences between the venous structures and brain tissues using rapid
QSM acquisition. Volumes with increased OEF values were compared to the ischemic
penumbra volumes using an anatomical template.
Adverse events
None
Outcome measures
In these patients, the volumes with increased OEF values of>51.5%, which was defined using the anterior circulation territory OEF values from the 21 healthy controls, were positively correlated with the ischemic penumbra volumes and inversely correlated with the 30-day change in the National Institutes of Health Stroke Scale scores.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
No longer recruiting
Date of protocol fixation
| 2020 | Year | 01 | Month | 03 | Day |
Date of IRB
| 2020 | Year | 01 | Month | 03 | Day |
Anticipated trial start date
| 2020 | Year | 03 | Month | 01 | Day |
Last follow-up date
| 2020 | Year | 09 | Month | 30 | Day |
Date of closure to data entry
| 2020 | Year | 09 | Month | 30 | Day |
Date trial data considered complete
| 2020 | Year | 09 | Month | 30 | Day |
Date analysis concluded
| 2020 | Year | 11 | Month | 01 | Day |
Other
Other related information
N.A.
Management information
Registered date
| 2020 | Year | 01 | Month | 03 | Day |
Last modified on
| 2023 | Year | 07 | Month | 07 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000044527
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