UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000019479
Receipt number R000022457
Scientific Title Japan Acute Myocardial Infarction Registry
Date of disclosure of the study information 2015/11/01
Last modified on 2016/02/18 09:38:59

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Basic information

Public title

Japan Acute Myocardial Infarction Registry

Acronym

JAMIR prospective study

Scientific Title

Japan Acute Myocardial Infarction Registry

Scientific Title:Acronym

JAMIR prospective study

Region

Japan


Condition

Condition

Acute myocardial infarction

Classification by specialty

Cardiology

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To evaluate ischemic event as well as bleeding event in patients with acute myocardial infarction and to investigate relationship between events and type of anti platelet therapy

Basic objectives2

Others

Basic objectives -Others

Ischemic event,Bleeding event

Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Ischemic event (cardiovascular death + nonfatal myocardial infarction + nonfatal cerebral infarction). Bleeding event (TIMI hemorrhage and BARC type 3+5)

Key secondary outcomes

Ischemic event (cardiovascular death + nonfatal myocardial infarction+ nonfatal cerebral infarction) + Bleeding event (TIMI hemorrhage) complex endpoint, nonfatal myocardial infarction, nonfatal cerebral infarction, cardiovascular death, overall death, stent thrombosis. Bleeding event( TIMI hemorrhage+ small bleeding, BARC type 2+3+5) ,Re-hospitalization by heart failure


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


Not applicable

Age-upper limit


Not applicable

Gender

Male and Female

Key inclusion criteria

Patients diagnosed as acute myocardial infarction by universal definition or MONICA criteria

(Universal definition)
Patients who satisfies one of the followings as well as find out rising myocardial deviation enzyme (Myocardial TOROPONIN is desirable.)
- The symptom of the ischemia
- New ST-T change or newly emerged left leg block
- Emerging an abnormal Q-wave in an electro cardiogram
- Confirmed either viable myocardium deviation or emerging new wall motion abnormality within the electro cardiogram.
- Confirmed thrombosis image within the coronary artery, either angiography or necropsy examination

(MONICA criteria)
More than 2 times of rise of the normal upper limit of the Creatinine kinase MB.
Or one of followings are satisfied while more than 2 times of rise of normal upper limit of Creatinine phosphokinase observed.
- The symptom of the myocardial ischemia
- Emerging an abnormal Q-wave in an electrocardiogram
- Either Rise of descent found among ST part within an electro-cardiogram

Key exclusion criteria

(1)Patients who developed acute myocardial infarction as a complication by PCI
(2)Patients who developed acute myocardial infarction after GABG as a perioperative complication
(3) Patients with delay of greater than or equal to 24 hours between onset of myocardial infarction and hospital admission
(4) Patients with prehospital cardiopulmonary arrest who are in state of continuous cardiopulmonary arrest on admission

Target sample size

3000


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Satoshi Yasuda

Organization

National Cerebral and Cardiovascular Center

Division name

Department of Cardiovascular Medicine

Zip code


Address

5-7-1 Fujishirodai,Suita,Osaka

TEL

06-6833-5012

Email

yasuda.satoshi.hp@ncvc.go.jp


Public contact

Name of contact person

1st name
Middle name
Last name Tadakazu Inoue

Organization

Quintiles Transnational Japan K.K.

Division name

Outcome Group Medical Affairs & Clinical Science

Zip code


Address

4-10-18 Takanawa,Minato,Tokyo

TEL

06-4807-9800

Homepage URL


Email

Tadakazu.Inoue@quintiles.com


Sponsor or person

Institute

Japan Cardiovascular Research Foundation

Institute

Department

Personal name



Funding Source

Organization

Daiichi Sankyo Company, Limited

Organization

Division

Category of Funding Organization

Other

Nationality of Funding Organization

Japan


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

2015 Year 11 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

Enrolling by invitation

Date of protocol fixation

2015 Year 10 Month 12 Day

Date of IRB


Anticipated trial start date

2015 Year 11 Month 01 Day

Last follow-up date


Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information

・Observational study
・Multi-center prospective study
・All patients that meet the eligibility criteria in the site from contract date to May 31 2017


Management information

Registered date

2015 Year 10 Month 23 Day

Last modified on

2016 Year 02 Month 18 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000022457


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name