UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000012049 |
|---|---|
| Receipt number | R000014086 |
| Scientific Title | Analysis of immune system and inflammatory molecules in cardiac disease. |
| Date of disclosure of the study information | 2013/11/01 |
| Last modified on | 2016/08/27 12:36:10 |
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Basic information
Public title
Analysis of immune system and inflammatory molecules in cardiac disease.
Acronym
Cardiac disease and immune system
Scientific Title
Analysis of immune system and inflammatory molecules in cardiac disease.
Scientific Title:Acronym
Cardiac disease and immune system
Region
| Japan |
Condition
Condition
Cardiac disease (acute coronary syndrome, angina pectoris, valvular disease, heart failure, arrhythmia, and so on)
Classification by specialty
| Cardiology | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Our aim is to calarify the mechanism and prognosis of cardiac disasese, by evaluating the expression and function of immune cells (monocyte, dendritic cells or Tcells), inflammatory molecules, and gut microbiota.
Basic objectives2
Others
Basic objectives -Others
Comparison of caridiac disease patients and healthy volunteers.
Trial characteristics_1
Others
Trial characteristics_2
Others
Developmental phase
Not applicable
Assessment
Primary outcomes
The discrepancy of immune system, inflammatory molecules, and gut microbiota between cardiac disease patients and healthy volunteers.
Key secondary outcomes
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
| 40 | years-old | <= |
Age-upper limit
| 70 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Healthy volunteers and patients with cardiac disease who agree to this study.
Key exclusion criteria
Patients who do not agree to this study and those who are not appropriate for this study.
Target sample size
250
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Kennichi Hirata |
Organization
Kobe University School of medicine
Division name
Department of cardiology
Zip code
Address
7-5-2 Kusunoki-cho Chuo-ku Kobe City
TEL
078-382-5846
hiratak@med.kobe-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Tomoya Yamashita |
Organization
Kobe University Hospital
Division name
Department of cardiology
Zip code
Address
7-5-2 Kusunoki-cho Chuo-ku Kobe City
TEL
078-382-5846
Homepage URL
tomoya@med.kobe-u.ac.jp
Sponsor or person
Institute
Department of cardiology Kobe University School of medicine
Institute
Department
Personal name
Funding Source
Organization
No
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
| 2013 | Year | 11 | Month | 01 | Day |
Related information
URL releasing protocol
Publication of results
Partially published
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
We reported 3 papers about inflammation and cardiovascular diseases
1) Regulatory/Effector T-cell ratio is reduced in coronary artery disease. (Circ J. 2014 Nov 25;78(12):2935-41)
2) Circulating intermediate CD14++CD16+monocytes are increased in patients with atrial fibrillation and reflect the functional remodelling of the left atrium.(Suzuki A et al Europace.2016.in press)
3) Analysis of gut microbiota in coronary artery disease patients: a possible link between gut microbiota and coronary artery disease. (Takuo E et al. Journal of Athersclerosis and Thrombosis 2016 in press)
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
Open public recruiting
Date of protocol fixation
| 2012 | Year | 10 | Month | 15 | Day |
Date of IRB
Anticipated trial start date
| 2012 | Year | 11 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
We are now gathering peripheral blood and stool of cardiac disease patients and healthy volunteers
Management information
Registered date
| 2013 | Year | 10 | Month | 16 | Day |
Last modified on
| 2016 | Year | 08 | Month | 27 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000014086
| Research Plan | |
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| Registered date | File name |
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| Registered date | File name |
| Research case data | |
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