UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000001683 |
|---|---|
| Receipt number | R000001131 |
| Scientific Title | Atherosclerosis Etiology Trial in Ehime |
| Date of disclosure of the study information | 2009/02/03 |
| Last modified on | 2020/03/04 18:21:06 |
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Basic information
Public title
Atherosclerosis Etiology Trial in Ehime
Acronym
ATHLETE
Scientific Title
Atherosclerosis Etiology Trial in Ehime
Scientific Title:Acronym
ATHLETE
Region
| Japan |
Condition
Condition
Ischemic Heart Disease
Classification by specialty
| Cardiology | Endocrinology and Metabolism |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To identify the pathophysiology of atherosclerosis, we plan to analyze gene expression in monocyte isolated from patient with ischemic heart disease. We also plan to compare the difference of 1) gene expression, 2) serum cytokine level and 3) adipokine level before and after treatment of angiotensin receptor blocker, statin, PPAR ligands.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Gene expression analysis(DNA array QRT-PCR) of total RNA from human monocyte.
Measurement of serum adipokines and cytokines.
Key secondary outcomes
Imaging examination and physiological test including IVUS and UCG
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
4
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Telmisartan
six month
80mg
once a day
Interventions/Control_2
Amlodipine
six month
5mg
once a day
Interventions/Control_3
Pioglitazone
six month
15mg
once a day
Interventions/Control_4
EPA
six month
1800mg
twice a day
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
| 60 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Inpatient with acute myocardial infarction or angina pectoris who needs treatment of catheter intervention. And treatment of hypertension.
Key exclusion criteria
past history of allergy to ARB or CCB or pioglitazone
pregnancy
liver dysfunction
cancer, collagen disease, infection
renal dysfunction (serum Cr>2mg/dl)
The patient whom Doctor decide insufficient to the study
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | Yasunori |
| Middle name | |
| Last name | Takata |
Organization
Ehime University Graduate school of Medicine
Division name
Department of Diabetes and Molecular Genetics
Zip code
7910295
Address
Sitsukawa, Toon city, Ehime, Japan
TEL
089-955-9728
ytakata@m.ehime-u.ac.jp
Public contact
Name of contact person
| 1st name | Yasunori |
| Middle name | |
| Last name | Takata |
Organization
Ehime university graduate school of medicine
Division name
Department of Diabetes and Molecular Genetics
Zip code
7910295
Address
Sitsukawa, Toon city, Ehime, Japan
TEL
089-955-9728
Homepage URL
ytakata@m.ehime-u.ac.jp
Sponsor or person
Institute
Ehime University Graduate school of Medicine, Department of Diabetes and Molecular Genetics
Institute
Department
Personal name
Funding Source
Organization
Japan Heart Foundation
Organization
Division
Category of Funding Organization
Non profit foundation
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Institutional Review Board, Ehime University Hospital
Address
Sitsukawa, Toon city, Ehime, Japan
Tel
089-960-5914
souyaku-post@m.ehime-u.ac.jp
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
| 2009 | Year | 02 | Month | 03 | 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
| 2006 | Year | 09 | Month | 29 | Day |
Date of IRB
Anticipated trial start date
| 2006 | Year | 10 | Month | 01 | Day |
Last follow-up date
| 2009 | Year | 09 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2009 | Year | 02 | Month | 02 | Day |
Last modified on
| 2020 | Year | 03 | Month | 04 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000001131
