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 | 2024/04/11 09:57:19 |
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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
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
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
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
Completed
Date of protocol fixation
| 2015 | Year | 10 | Month | 12 | Day |
Date of IRB
| 2015 | Year | 06 | Month | 19 | Day |
Anticipated trial start date
| 2015 | Year | 11 | Month | 01 | Day |
Last follow-up date
| 2018 | Year | 05 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
| 2024 | Year | 02 | Month | 28 | Day |
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
| 2024 | Year | 04 | Month | 11 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000022457
