UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Retrospective Multicenter Registry of Coronary Artery Stenting for Acute Myocardial Infarction in Shiga Prefecture
Title of the study (Brief title)	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	Teruki Takeda
Organization	Koto Memorial Hospital
Division name	Department of cardiology
Address	Hiramatsu-cho2-1, Higashioumi city, Shiga, Japan
TEL	0749-45-5000
Email	ttakeda18@mac.com

Public contact
Name of contact person	Akihiro Nishizawa
Organization	Koto Memorial Hospital
Division name	General affairs
Address	Hiramatsu-cho2-1, Higashioumi city, Shiga, Japan
TEL	0749-45-5000
Homepage URL
Email	subaru@koto-hp.jp

Sponsor
Institute	Shiga Catheter Intervention Conference
Institute
Department

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)

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

Progress
Recruitment status	Preinitiation
Date of protocol fixation	2018 Year 06 Month 02 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000036482