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UMIN ID:

Recruitment status
Unique ID issued by UMIN C000000021
Receipt No. R000000041
Scientific Title Nagoya Acute Myocardial Infarction Study
Date of disclosure of the study information 2006/07/01
Last modified on 2008/01/05

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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
Email

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
Email namis758@med.nagoya-u.ac.jp

Sponsor
Institute Japan Heart Foundation
Institute
Department

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
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
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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000041

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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