UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000001022 |
|---|---|
| Receipt number | 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 10:13:12 |
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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
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
kohno.ta@gmail.com
Sponsor or person
Institute
Keio University School of Medicine, Department of Medicine, Division of Cardiology
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000001232
