UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000031941 |
|---|---|
| Receipt number | R000036482 |
| Scientific Title | Retrospective Multicenter Registry of Coronary Artery Stenting for Acute Myocardial Infarction in Shiga Prefecture |
| Date of disclosure of the study information | 2018/03/31 |
| Last modified on | 2018/09/27 23:18:48 |
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Basic information
Public title
Retrospective Multicenter Registry of Coronary Artery Stenting for Acute Myocardial Infarction in Shiga Prefecture
Acronym
Shiga AMI registry
Scientific Title
Retrospective Multicenter Registry of Coronary Artery Stenting for Acute Myocardial Infarction in Shiga Prefecture
Scientific Title:Acronym
Shiga AMI registry
Region
| Japan |
Condition
Condition
Acute Myocardial Infarction
Classification by specialty
| Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Patients with acute myocardial infarction who underwent coronary artery stenting are registered retrospectively in multiple centers in Shiga prefecture, and their clinical results are examined.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Primary endpoint of this study is the composite endpoints of cardiovascular death, myocardial infarction, stroke (ischemic and hemorrhagic), stent thrombosis, and severe bleeding (BARC type2,3,5) at 60-month. The relationship between the primary endpoint and the duration of dual antiplatelet therapy will also be examined.
Key secondary outcomes
1. Composite endpoints of cardiovascular death, myocardial infarction, stroke, definite stent thrombosis, and severe bleeding at 12-month.
2. Mortality rate at discharge, 12-month, and 60-month.
3. Relationship between bleeding / thrombotic score (DAPT score, PRECISE DAPT score, PARIS score) and bleeding / thrombotic event.
4. Relationship between ischemic time (from onset to reperfusion) and the rate of death, cardiovascular death, and heart failure hospitalization at discharge, 12-month and 60-month.
5. Relationship between the presence of residual coronary artery lesion and the rate of death, cardiovascular death, and heart failure hospitalization at discharge, 12-month and 60-month.
6. Relationship between diabetes / dyslipidemia management after discharge and the rate of death, myocardial infarction, stroke, severe bleeding (BARC type2,3,5), and heart failure hospitalization at 60-month.
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
Patient diagnosed as acute myocardial infarction at the participating centers and received coronary artery stenting from January, 2010 to December, 2012.
Key exclusion criteria
1) Acute myocardial infarction where a condition other than coronary artery disease contributes to an ischemic imbalance (ex. coronary artery spasm, embolization, ischemia due to tachycardia, bradycardia, anemia, respiratory failure, and hypotension).
2) Acute myocardial infarction related to PCI and CABG.
3) Acute myocardial infarction resulting in death when biomarkers are unavailable.
Target sample size
500
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Teruki Takeda |
Organization
Koto Memorial Hospital
Division name
Department of cardiology
Zip code
Address
Hiramatsu-cho2-1, Higashioumi city, Shiga, Japan
TEL
0749-45-5000
ttakeda18@mac.com
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Akihiro Nishizawa |
Organization
Koto Memorial Hospital
Division name
General affairs
Zip code
Address
Hiramatsu-cho2-1, Higashioumi city, Shiga, Japan
TEL
0749-45-5000
Homepage URL
subaru@koto-hp.jp
Sponsor or person
Institute
Shiga Catheter Intervention Conference
Institute
Department
Personal name
Funding Source
Organization
Self funding
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
Address
Tel
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
| 2018 | Year | 03 | 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
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
Preinitiation
Date of protocol fixation
| 2018 | Year | 06 | Month | 02 | Day |
Date of IRB
Anticipated trial start date
| 2018 | Year | 06 | Month | 02 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
We conduct observational studies and report major outcomes.
Management information
Registered date
| 2018 | Year | 03 | Month | 28 | Day |
Last modified on
| 2018 | Year | 09 | Month | 27 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036482
