UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000041615 |
|---|---|
| Receipt number | R000047503 |
| Scientific Title | Pathological and biological assessment of arterial thrombus retrieved from infarct-related artery in patients with or without atrial fibrillation |
| Date of disclosure of the study information | 2020/08/31 |
| Last modified on | 2023/03/06 11:04:47 |
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Basic information
Public title
Pathological and biological assessment of arterial thrombus retrieved from infarct-related artery in patients with or without atrial fibrillation
Acronym
Macrophage in thrombus study
Scientific Title
Pathological and biological assessment of arterial thrombus retrieved from infarct-related artery in patients with or without atrial fibrillation
Scientific Title:Acronym
Macrophage in thrombus study
Region
| Japan |
Condition
Condition
Stroke and acute myocardial infarction
Classification by specialty
| Cardiology | Neurosurgery |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To assess the difference in pathology of thrombus retrieved from infarct-related artery between atrial fibrillation and non-atrial fibrillation
Basic objectives2
Others
Basic objectives -Others
To assess the difference in pathology or biological markers of thrombus retrieved from infarct-related artery between atrial fibrillation and non-atrial fibrillation
Trial characteristics_1
Exploratory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
Distribution of M1, M2 macrophage in thrombus
Key secondary outcomes
classification of thrombus defined as follows; fresh, lytic, organized,
markers in thrombus,
biomarkers in serum
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
stroke within 6 hours from symptom onset,
acute myocardial infarction within 12 hours from symptom onset,
successfully retrieved thrombus from infarct-related artery
Key exclusion criteria
hepatic disease, renal failure(eGFR<30), active malignancy, collagen disease, contraindication of emergent catheter treatment, not suitable for the inclusion judged by operator.
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Tomomi |
| Middle name | |
| Last name | Koizumi |
Organization
National Hospital Organization Mito Medical Center
Division name
Division of Cardiovascular Medicine
Zip code
311-3193
Address
280 Sakuranosato Ibarakimachi, Higashi-Ibarakigun, Ibaraki, Japan
TEL
+81292407711
tkoizumioffice@gmail.com
Public contact
Name of contact person
| 1st name | Tomomi |
| Middle name | |
| Last name | Koizumi |
Organization
National Hospital Organization Mito Medical Center
Division name
Division of Cardiovascular Medicine
Zip code
311-3193
Address
280 Sakuranosato Ibarakimachi
TEL
+81292407711
Homepage URL
tkoizumioffice@gmail.com
Sponsor or person
Institute
National Hospital Organization Mito Medical Center
Institute
Department
Personal name
Funding Source
Organization
National Hospital Organization Mito Medical Center
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
National Hospital Organization Mito Medical Center
Address
280 Sakuranosato Ibarakimachi
Tel
+81292407711
tkoizumioffice@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
国立病院機構水戸医療センター（茨城県）
Other administrative information
Date of disclosure of the study information
| 2020 | Year | 08 | Month | 31 | 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
93
Results
Distribution of CD163 positive macrophage in thrombus from IRA in patients with atrial fibrillation is larger than that in patients with sinus rhythm.
Results date posted
| 2022 | Year | 03 | Month | 15 | Day |
Results Delayed
| Delay expected |
Results Delay Reason
Pathological analyses have been almost finished and overall analysis has been started.
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
none
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
No longer recruiting
Date of protocol fixation
| 2019 | Year | 05 | Month | 31 | Day |
Date of IRB
| 2019 | Year | 05 | Month | 15 | Day |
Anticipated trial start date
| 2019 | Year | 06 | Month | 01 | Day |
Last follow-up date
| 2020 | Year | 12 | Month | 30 | Day |
Date of closure to data entry
| 2021 | Year | 02 | Month | 28 | Day |
Date trial data considered complete
| 2021 | Year | 03 | Month | 31 | Day |
Date analysis concluded
| 2021 | Year | 03 | Month | 31 | Day |
Other
Other related information
Once pathological samples are collected, the samples are stained. When other stains are needed, the samples are stained again.
Management information
Registered date
| 2020 | Year | 08 | Month | 31 | Day |
Last modified on
| 2023 | Year | 03 | Month | 06 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000047503
| Research Plan | |
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| Registered date | File name |
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| Registered date | File name |
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