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

Email

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


Email

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


Email



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


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name