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Name:
UMIN ID:

Recruitment status
Unique ID issued by UMIN UMIN000001932
Receipt No. R000002354
Scientific Title Gene expression profiling of peripheral blood mononuclear cells in patients with cardiovascular disease
Date of disclosure of the study information 2009/06/01
Last modified on 2009/05/01

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Basic information
Public title Gene expression profiling of peripheral blood mononuclear cells in patients with cardiovascular disease
Acronym Gene expression profiling of peripheral blood mononuclear cells in patients with cardiovascular disease
Scientific Title Gene expression profiling of peripheral blood mononuclear cells in patients with cardiovascular disease
Scientific Title:Acronym Gene expression profiling of peripheral blood mononuclear cells in patients with cardiovascular disease
Region
Japan

Condition
Condition Cardiovascular disease
Classification by specialty
Cardiology
Classification by malignancy Others
Genomic information YES

Objectives
Narrative objectives1 To investigate the gene expression profiling of systemic organs in patients with cardiovascular disease
Basic objectives2 Others
Basic objectives -Others Prognosis
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Adverse cardiac events: cardiac death, non-fatal myocardial infarction, heart failure, sustained ventricular tachycardia
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

Not applicable
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria Patients suffered from Ischemic heart disease, Cardiomyopathy, Severe arrhythmia, Atherosclerotic disease
Key exclusion criteria Renal dysfunction requiring hemodialysis
Target sample size 100

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Shuichi Kaneko
Organization Kanazawa University Graduate School of Medical Science
Division name Department of Disease Control and Homeostasis
Zip code
Address 13-1Takara-machi, Kanazawa, Ishikawa
TEL
Email

Public contact
Name of contact person
1st name
Middle name
Last name Masayuki Takamura
Organization Kanazawa University Graduate School of Medical Science
Division name Department of Disease Control and Homeostasis
Zip code
Address 13-1Takara-machi, Kanazawa, Ishikawa
TEL
Homepage URL
Email

Sponsor
Institute Kanazawa University Graduate School of Medical Science
Institute
Department

Funding Source
Organization Kanazawa University Graduate School of Medical Science
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
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 06 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
Date of protocol fixation
2008 Year 04 Month 01 Day
Date of IRB
Anticipated trial start date
2009 Year 04 Month 01 Day
Last follow-up date
2012 Year 03 Month 01 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information Prospective study after registration and collecting peripheral blood sample

Management information
Registered date
2009 Year 05 Month 01 Day
Last modified on
2009 Year 05 Month 01 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002354

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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