UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000054330 |
|---|---|
| Receipt number | R000062064 |
| Scientific Title | Research on nano- and microplastics contained in thrombi of cardiogenic cerebral embolism. |
| Date of disclosure of the study information | 2024/05/07 |
| Last modified on | 2025/08/13 15:33:56 |
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Basic information
Public title
Research on nano- and microplastics contained in thrombi of cardiogenic cerebral embolism.
Acronym
Research on nano- and microplastics contained in thrombi of cardiogenic cerebral embolism.
Scientific Title
Research on nano- and microplastics contained in thrombi of cardiogenic cerebral embolism.
Scientific Title:Acronym
Research on nano- and microplastics contained in thrombi of cardiogenic cerebral embolism.
Region
| Japan |
Condition
Condition
cerebral infarction
Classification by specialty
| Medicine in general | Neurology | Neurosurgery |
| Laboratory medicine | Emergency medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To identify the presence of nano- and microplastics within embolised thrombi in patients with cardiogenic cerebral embolism.
Basic objectives2
Others
Basic objectives -Others
Chemical analysis of nano- and microplastics within embolised thrombi in patients with cardiogenic cerebral embolism.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Presence of plastic within the thrombus
Key secondary outcomes
Presence of other foreign materials within the thrombus (e.g. vinyl chloride)
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
Inclusion criteria.
Patients who meet the following criteria
1) Patients who have undergone mechanical thrombectomy due to cardiogenic cerebral embolism and the thrombus has been retrieved
2) Patients who have given consent to participate in the study (in person or by a substitute).
Key exclusion criteria
Exclusion Criteria.
Patients judged by two physicians to be unfit to participate in the study
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Yuya |
| Middle name | |
| Last name | Kobayashi |
Organization
Ina Central Hospital
Division name
Neurology
Zip code
3968555
Address
Koshirokubo 1313-1, Ina
TEL
0265-72-3121
juriruri@inahp.jp
Public contact
Name of contact person
| 1st name | Yuya |
| Middle name | |
| Last name | Kobayashi |
Organization
Ina Central Hospital
Division name
Neurology
Zip code
3968555
Address
Koshirokubo 1313-1, Ina
TEL
0265723121
Homepage URL
juriruri@inahp.jp
Sponsor or person
Institute
Ina Central Hospital
Institute
Department
Personal name
Funding Source
Organization
Ina Central Hospital
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Ina Central Hospital
Address
1313-1, Koshirokubo, Ina
Tel
0265723121
info@inahp.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
| 2024 | Year | 05 | Month | 07 | 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
Suspended
Date of protocol fixation
| 2024 | Year | 05 | Month | 07 | Day |
Date of IRB
| 2024 | Year | 05 | Month | 07 | Day |
Anticipated trial start date
| 2024 | Year | 05 | Month | 07 | Day |
Last follow-up date
| 2025 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
None.
Management information
Registered date
| 2024 | Year | 05 | Month | 07 | Day |
Last modified on
| 2025 | Year | 08 | Month | 13 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000062064
