UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000016482 |
|---|---|
| Receipt number | R000019142 |
| Scientific Title | Clinical Significance of Helicobacter Pylori Infection and Interleukin-1 Polymorphism with Acute Myocardial Infarction |
| Date of disclosure of the study information | 2015/02/09 |
| Last modified on | 2015/04/03 16:34:24 |
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Basic information
Public title
Clinical Significance of Helicobacter Pylori Infection and Interleukin-1 Polymorphism with Acute Myocardial Infarction
Acronym
Clinical Significance of Helicobacter Pylori Infection and Interleukin-1 Polymorphism with Acute Myocardial Infarction
Scientific Title
Clinical Significance of Helicobacter Pylori Infection and Interleukin-1 Polymorphism with Acute Myocardial Infarction
Scientific Title:Acronym
Clinical Significance of Helicobacter Pylori Infection and Interleukin-1 Polymorphism with Acute Myocardial Infarction
Region
| Japan |
Condition
Condition
Acute myocardial infarction
Classification by specialty
| Cardiology |
Classification by malignancy
Others
Genomic information
YES
Objectives
Narrative objectives1
To evaluate the effect of Helicobacter pylori infection and interleukin-1 polymorphisms on acute myocardial
infarction
Basic objectives2
Others
Basic objectives -Others
Assessment of pathophysiology
Trial characteristics_1
Exploratory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
The prevalence of Helicobacter pylori infection and interleukin-1 polymorphisms in patients with acute myocardial infarction
Key secondary outcomes
Inflammation
Peripheral endothelial function
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
We registered patients who were admitted to Kumamoto University Hospital for acute myocardial infarction and who did not have atherosclerotic diseases
Key exclusion criteria
1. end-stage renal disease on hemodialysis
2. severe liver dysfunction
3. malignant disease with severe prognosis
4. other inflammatory disease
5. severe sickness
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Hisao Ogawa |
Organization
Graduate School of Medical Sciences, Kumamoto University
Division name
Department of Cardiovascular Medicine
Zip code
Address
1-1-1, Honjo, Chuo-ku, Kumamoto City
TEL
096-373-5175
cvmhisho@kumamoto-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Seiji Hokimoto |
Organization
Graduate School of Medical Sciences, Kumamoto University
Division name
Department of Cardiovascular Medicine
Zip code
Address
1-1-1, Honjo, Chuo-ku, Kumamoto City
TEL
096-373-5175
Homepage URL
shokimot@kumamoto-u.ac.jp
Sponsor or person
Institute
Department of Cardiovascular Medicine, Graduate School of Medical Sciences, Kumamoto University
Institute
Department
Personal name
Funding Source
Organization
The Ministry of Education, Science, and Culture in Japan
Organization
Division
Category of Funding Organization
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
| 2015 | Year | 02 | Month | 09 | 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
| 2009 | Year | 01 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2009 | Year | 01 | Month | 08 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
We examined infections of Helicobacter pylori by analyzing Helicobacter pylori IgG antibody and genetic
polymorphisms of interleukin-1 in patients who admitted to our hospital for acute myocardial infarction and who
did not have coronary heart disease.
Management information
Registered date
| 2015 | Year | 02 | Month | 09 | Day |
Last modified on
| 2015 | Year | 04 | Month | 03 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019142
