UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000055449 |
|---|---|
| Receipt number | R000063359 |
| Scientific Title | Differences in the pathogenesis of acute coronary syndrome based on aspiration thrombus findings, and examination of background factors and prognosis |
| Date of disclosure of the study information | 2024/09/06 |
| Last modified on | 2025/10/05 16:11:59 |
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Basic information
Public title
Differences in the pathogenesis of acute coronary syndrome based on aspiration thrombus findings, and examination of background factors and prognosis
Acronym
Differences in the pathogenesis of acute coronary syndrome
Scientific Title
Differences in the pathogenesis of acute coronary syndrome based on aspiration thrombus findings, and examination of background factors and prognosis
Scientific Title:Acronym
Differences in the pathogenesis of acute coronary syndrome
Region
| Japan |
Condition
Condition
acute coronary syndromes
Classification by specialty
| Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
By examining the causes of acute coronary syndromes (rupture of arterial atherosclerosis, erosion and calcification of arteriosclerosis) and their background, we will clarify the onset mode, clinical course, and prognosis of each disease state.
Basic objectives2
Others
Basic objectives -Others
By examining the causes of acute coronary syndromes (rupture of arterial atherosclerosis, erosion and calcification of arteriosclerosis) and their background, we will clarify the onset mode, clinical course, and prognosis of each disease state.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Coronary artery restenosis after 6-12 months, presence or absence of new lesions, presence or absence of acute coronary syndrome recurrence up to 5 years after initial hospitalization, presence or absence of heart failure hospitalization, and death as an outcome.
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
| 16 | years-old | <= |
Age-upper limit
| 90 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Patients who was admitted to our department with acute coronary syndrome, underwent coronary artery intervention, and underwent thrombus aspiration.
Key exclusion criteria
Patients who underwent thrombus aspiration due to acute coronary syndrome, but the aspiration specimen was not submitted to pathology
Target sample size
300
Research contact person
Name of lead principal investigator
| 1st name | Koji |
| Middle name | |
| Last name | Maemura |
Organization
Nagasaki University Graduate School of Biomedical Sciences
Division name
Department of Cardiovascular Medicine
Zip code
852-8501
Address
1-7-1 Sakamoto, Nagasaki, Japan
TEL
0958197288
maemura@nagasaki-u.ac.jp
Public contact
Name of contact person
| 1st name | Hiroaki |
| Middle name | |
| Last name | Kawano |
Organization
Nagasaki University Graduate School of Biomedical Sciences, Nagasaki, Japan
Division name
Department of Cardiovascular Medicine
Zip code
852-8501
Address
1-7-1 Sakamoto, Nagasaki, Japan
TEL
0958197288
Homepage URL
hkawano@nagasaki-u.ac.jp
Sponsor or person
Institute
Nagasaki University Graduate School of Biomedical Sciences, Nagasaki, Japan
Institute
Department
Personal name
Funding Source
Organization
none
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
Nagasaki University Hospital Clinical Research Ethics Committee
Address
1-7-1 Sakamoto, Nagasaki, Japan
Tel
0958197726
tokuteings@umin.ac.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 | 09 | Month | 06 | 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
| 2015 | Year | 04 | Month | 01 | Day |
Date of IRB
| 2024 | Year | 09 | Month | 05 | Day |
Anticipated trial start date
| 2024 | Year | 09 | Month | 06 | Day |
Last follow-up date
| 2030 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Background, laboratory data
Management information
Registered date
| 2024 | Year | 09 | Month | 06 | Day |
Last modified on
| 2025 | Year | 10 | Month | 05 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000063359
