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Name:
UMIN ID:

Recruitment status
Unique ID issued by UMIN UMIN000001683
Receipt No. R000001131
Scientific Title Atherosclerosis Etiology Trial in Ehime
Date of disclosure of the study information 2009/02/03
Last modified on 2009/02/02

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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

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit
Blinding Double blind -all involved are blinded
Control Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
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
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
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
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
Middle name
Last name Hideki Okayama
Organization Ehime University Graduate school of Medicine
Division name Integrated Medicine and Infomatics,
Zip code
Address Sitsukawa, Toon city, Ehime, Japan
TEL 089-955-9350
Email

Public contact
Name of contact person
1st name
Middle name
Last name Yasunori Takata
Organization Ehimeuniversity, graduate school of medicine
Division name Department of molecular and genetic medicine
Zip code
Address Sitsukawa, Toon city, Ehime, Japan
TEL 089-955-9728
Homepage URL
Email ytakata@m.ehime-u.ac.jp

Sponsor
Institute Ehime University Graduate school of Medicine, Integrated Medicine and Infomatics
Institute
Department

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
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
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
2009 Year 02 Month 02 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000001131

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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