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Name:
UMIN ID:

Recruitment status Terminated
Unique ID issued by UMIN UMIN000001022
Receipt No. R000001232
Scientific Title A clinical study to evaluate the role of proinflammatory cytokines in acute myocardial infarction
Date of disclosure of the study information 2012/03/01
Last modified on 2017/12/18

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Basic information
Public title A clinical study to evaluate the role of proinflammatory cytokines in acute myocardial infarction
Acronym A clinical study on the inflammation in acute myocardial infarction
Scientific Title A clinical study to evaluate the role of proinflammatory cytokines in acute myocardial infarction
Scientific Title:Acronym A clinical study on the inflammation in 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 the role of proinflammatory cytokines in the pathogenesis of left ventricular remodeling after acute myocardial infarction
Basic objectives2 Others
Basic objectives -Others to examine the clinical significance of the elevation of serum proinflammatory cytokine level
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes in hospital and out of hospital clinical complications (pump failure, cardiac rupture, VT/VF, cardiac death)
Key secondary outcomes left ventricular remodeling (echocardiography and left ventriculography)
biomarker (white blood cell counts, CK, CRP, BNP, proinflammatory cytokines)

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 patients with first ST-elevation acute myocardial infarction, in whom time elapsed from onset to admission was within 24 hours
Key exclusion criteria infectious disease, collagen disease, malignancy, advanced liver disease, and renal failure
Target sample size 150

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Takashi Kohno
Organization Keio University School of Medicine, Department of Medicine
Division name Division of Cardiology
Zip code
Address 35 Shinanomachi, Shinjuku-ku, Tokyo
TEL 033531211
Email kohno.ta@gmail.com

Public contact
Name of contact person
1st name
Middle name
Last name Takashi Kohno
Organization Keio University School of Medicine, Department of Medicine
Division name Division of Cardiology
Zip code
Address 35 Shinanomachi Shinjuku-ku
TEL 03-5363-3793
Homepage URL
Email kohno.ta@gmail.com

Sponsor
Institute Keio University School of Medicine, Department of Medicine, Division of Cardiology
Institute
Department

Funding Source
Organization Office of research administration at Shinanomachi, Keio University
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

Other administrative information
Date of disclosure of the study information
2012 Year 03 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 Terminated
Date of protocol fixation
2008 Year 02 Month 09 Day
Date of IRB
Anticipated trial start date
2008 Year 02 Month 09 Day
Last follow-up date
2011 Year 12 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information prospective cohort study

Management information
Registered date
2008 Year 02 Month 09 Day
Last modified on
2017 Year 12 Month 18 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000001232

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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