UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000060108 |
|---|---|
| Receipt number | R000068465 |
| Scientific Title | Clinical usefulness of measuring the content of amino acids modified by the Maillard reaction in vivo in acute cerebral infarction |
| Date of disclosure of the study information | 2025/12/19 |
| Last modified on | 2025/12/18 09:02:05 |
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Basic information
Public title
Clinical usefulness of measuring the content of amino acids modified by the Maillard reaction in vivo in acute cerebral infarction
Acronym
Clinical usefulness of measuring the content of amino acids modified by the Maillard reaction in vivo in acute cerebral infarction
Scientific Title
Clinical usefulness of measuring the content of amino acids modified by the Maillard reaction in vivo in acute cerebral infarction
Scientific Title:Acronym
Clinical usefulness of measuring the content of amino acids modified by the Maillard reaction in vivo in acute cerebral infarction
Region
| Japan |
Condition
Condition
acute ischemic stroke
Classification by specialty
| Neurosurgery |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The main objectives of this study are to 1 discover the usefulness of this as a new indicator that can predict the progression of acute cerebral infarction, 2 discover the usefulness of non invasive AGE measurement using an AGE sensor in this field, and 3 identify more specific structures that can predict acute cerebral infarction.
Basic objectives2
Bio-availability
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Primary endpoint: Patient outcome (mRS) one month after surgery.
Secondary endpoint: Improvement in NIHSS score 24 hours after surgery.
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
1. Subjects aged 18 years or older
2. Subjects who are deemed to be thrombectomy recipients by a full-time physician at Fukuoka Neurosurgical Hospital
3. Subjects who have received sufficient information regarding participation in this study and have provided written consent of their own free will
4. Subjects who are unable to make their own decisions, and whose blood relatives have provided written consent
Key exclusion criteria
1. Those whose thrombus could not be retrieved
2. Those who are otherwise deemed inappropriate by the principal investigator or investigator
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | Kiyoshi |
| Middle name | |
| Last name | Kazekawa |
Organization
Fukuoka Neurosurgical Hospital
Division name
Department of neurosurgery
Zip code
811-1313
Address
5-3-15, Osa, Minami-ku, Fukuoka-shi, Fukuoka-ken, Japan
TEL
+81-92-558-0081
takashigreengreen@gmail.com
Public contact
Name of contact person
| 1st name | Takashi |
| Middle name | |
| Last name | Fujii |
Organization
Fukuoka Neurosurgical Hospital
Division name
Department of Neurosurgery
Zip code
811-1313
Address
5-3-15, Osa, Minami-ku, Fukuoka-shi, Fukuoka-ken, Japan
TEL
+81-92-558-0081
Homepage URL
takashigreengreen@gmail.com
Sponsor or person
Institute
Fukuoka Neurosurgical Hospital
Institute
Department
Personal name
Funding Source
Organization
Fukuoka Neurosurgical Hospital
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Tokai university IRB comittee
Address
143, Shimokasuya, Isehara0shi, Kanagawa-ken, Japan
Tel
+81463-93-1121
tokairinri5050@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
| 2025 | Year | 12 | Month | 19 | 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
Open public recruiting
Date of protocol fixation
| 2025 | Year | 08 | Month | 15 | Day |
Date of IRB
| 2025 | Year | 08 | Month | 12 | Day |
Anticipated trial start date
| 2025 | Year | 08 | Month | 15 | Day |
Last follow-up date
| 2029 | Year | 07 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
not paticular
Management information
Registered date
| 2025 | Year | 12 | Month | 18 | Day |
Last modified on
| 2025 | Year | 12 | Month | 18 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000068465
