UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000025493
Receipt number R000029338
Scientific Title Multicenter study of clinical characteristics and prognosis in subjects with acute myocardial infarction
Date of disclosure of the study information 2017/01/01
Last modified on 2023/01/24 20:29:52

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Basic information

Public title

Multicenter study of clinical characteristics and prognosis in subjects with acute myocardial infarction

Acronym

Multicenter study in subjects with acute myocardial infarction

Scientific Title

Multicenter study of clinical characteristics and prognosis in subjects with acute myocardial infarction

Scientific Title:Acronym

Multicenter study in subjects with acute myocardial infarction

Region

Japan


Condition

Condition

acute myocardial infarction

Classification by specialty

Cardiology

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To examine clinical characteristics, treatment, and prognosis in subjects with acute myocardial infarction.

Basic objectives2

Others

Basic objectives -Others

And to clarify clinical problem in the real practice.

Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Major adverse cardiovascular event, including all-cause death, re-infarction, target lesion revascularization, cerebrovascular disease (infarction or transient ischemic attack), stent thrombosis.

Key secondary outcomes

Prevalence of frailty, and its change during study period
Nutrition status and its change during study period
hemorrhagic complication
Malignant tumor


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

20 years-old <=

Age-upper limit

100 years-old >=

Gender

Male and Female

Key inclusion criteria

Subjects admitted by acute myocardial infaction
1. Age>=20 years
2. Subjects admited during acute phase
3. Any gender
4. Subjects with written informed consent

Key exclusion criteria

Subjects who are considered inadequate

Target sample size

1300


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Mitsutoshi Oguri

Organization

Kasugai Municipal Hospital

Division name

Department of Cardiology

Zip code


Address

1-1-1 Takaki-cho, Kasugai 486-8510, Japan

TEL

0568-57-0057

Email

oguricap0909@gmail.com


Public contact

Name of contact person

1st name
Middle name
Last name Mitsutoshi Oguri

Organization

Kasugai Municipal Hospital

Division name

Department of Cardiology

Zip code


Address

1-1-1 Takaki-cho, Kasugai 486-8510, Japan

TEL

0568-57-0057

Homepage URL


Email

oguricap0909@gmail.com


Sponsor or person

Institute

Department of Cardiology, Kasugai Municipal Hospital

Institute

Department

Personal name



Funding Source

Organization

Department of Cardiology, Kasugai Municipal Hospital

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

海南病院(愛知県) 循環器内科
名古屋医療センター(愛知県) 循環器科


Other administrative information

Date of disclosure of the study information

2017 Year 01 Month 01 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

Completed

Date of protocol fixation

2016 Year 10 Month 20 Day

Date of IRB

2016 Year 10 Month 20 Day

Anticipated trial start date

2017 Year 01 Month 01 Day

Last follow-up date

2021 Year 12 Month 31 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information

Enroll period: 1 Jan. 2017 - 31 Dec. 2019
Stuy period: 1 Jan. 2017 - 31 Dec. 2021


Management information

Registered date

2017 Year 01 Month 01 Day

Last modified on

2023 Year 01 Month 24 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029338


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name