UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | C000000021 |
|---|---|
| Receipt number | R000000041 |
| Scientific Title | Nagoya Acute Myocardial Infarction Study |
| Date of disclosure of the study information | 2006/07/01 |
| Last modified on | 2008/01/05 12:17:59 |
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Basic information
Public title
Nagoya Acute Myocardial Infarction Study
Acronym
NAMIS
Scientific Title
Nagoya Acute Myocardial Infarction Study
Scientific Title:Acronym
NAMIS
Region
| Japan |
Condition
Condition
acute myocardial infarction
Classification by specialty
| Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
observasional study about the prognosis of acute myocardial infarction in Japanese subject
Basic objectives2
Others
Basic objectives -Others
observasional study
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Occurrence of death,and stroke, acute coronary syndrome and acute heart failure requiring emergency admission
Key secondary outcomes
Revasculization for the culprit lesion
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
Patients who induced acute myocardial infarction (AMI) and undertook coronary angioplasty within 24 hours after the onset were included.
AMI was defined as fulfilling at least two items described below:
1. Maximum creatine kinese level (max CK) exceeded more than twice as much as the normal high limit.
2. Serial change of electrocariography was observed.
3. Typical symptoms such as chest pain continued for more than 30 minutes.
Key exclusion criteria
Exclusion criteria are defined as following:
1. In case patients were diagnosed AMI after 24 hours its onset
2. In case max CK did not exceed twice as much as the normal high limit
3. In case informed consent was not performed
4. In case coronary angioplasty was not performed
5. Iatrogencally induced AMI
Target sample size
1000
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Toyoaki Murohara |
Organization
Nagoya University Graduate School of Medicine, Nagoya, Japan
Division name
Department of Cardiology
Zip code
Address
65 Tsurumai-cho, Showa-ku, Nagoya, Aichi 466-8550 Japan.
TEL
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name |
Organization
Nagoya University Graduate School of Medicine, Nagoya, Japan
Division name
Department of Cardiology
Zip code
Address
Tsurumai-cho 65, Showa-ku, Nagoya
TEL
052-744-0388
Homepage URL
namis758@med.nagoya-u.ac.jp
Sponsor or person
Institute
Japan Heart Foundation
Institute
Department
Personal name
Funding Source
Organization
Japan Heart Foundation
Organization
Division
Category of Funding Organization
Non profit foundation
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
| 2006 | Year | 07 | 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
Date of protocol fixation
| 2004 | Year | 01 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2004 | Year | 01 | Month | 01 | Day |
Last follow-up date
| 2013 | Year | 01 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
In the present study, efficacy of statins in the prevention of post-AMI cardiovascular events has been examined in Japanse.
Management information
Registered date
| 2005 | Year | 07 | Month | 05 | Day |
Last modified on
| 2008 | Year | 01 | Month | 05 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000041
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
