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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000002117
Receipt No. R000002579
Scientific Title Prognostic value of CD144 positive endothelium-derived-microparticles (CD144-EMP) in patients with heart failure
Date of disclosure of the study information 2009/07/30
Last modified on 2009/06/24

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Basic information
Public title Prognostic value of CD144 positive endothelium-derived-microparticles (CD144-EMP) in patients with
heart failure
Acronym Prognostic value of endothelial microparticles in patients with
heart failure
Scientific Title Prognostic value of CD144 positive endothelium-derived-microparticles (CD144-EMP) in patients with
heart failure
Scientific Title:Acronym Prognostic value of endothelial microparticles in patients with
heart failure
Region
Japan

Condition
Condition Japanese patinets with heart failure
Classification by specialty
Cardiology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Heart failure (HF) is associated with endothelial dysfunction. Endothelium-derived-microparticles (EMP) are a novel quantitative plasma marker of endothelial dysfunction. We investigated whether plasma EMP levels can predict future HF events in patients with HF.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Heart failure events (re-hospitalization for HF, valvular operation, or cardiovascular death).
Key secondary outcomes none

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
85 years-old >
Gender Male and Female
Key inclusion criteria Stage B or more at classification assessed by ACC/AHA guideline
Key exclusion criteria The exclusion criteria for the study were severe valvular heart disease requiring surgical intervention within one month, active infection, malignant disease, and acute coronary syndrome.
Target sample size 300

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 Kumamoto, Kumamoto, Japan
TEL
Email

Public contact
Name of contact person
1st name
Middle name
Last name
Organization Graduate School of Medical Sciences, Kumamoto University
Division name Department of Cardiovascular Medicine
Zip code
Address
TEL 096-373-5175
Homepage URL
Email

Sponsor
Institute Kumamoto University Hospital
Institute
Department

Funding Source
Organization Self funding
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 07 Month 30 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
2003 Year 05 Month 01 Day
Date of IRB
Anticipated trial start date
2003 Year 05 Month 01 Day
Last follow-up date
2009 Year 04 Month 01 Day
Date of closure to data entry
2009 Year 06 Month 01 Day
Date trial data considered complete
2009 Year 06 Month 01 Day
Date analysis concluded
2009 Year 06 Month 01 Day

Other
Other related information We followed up study patients on outpatients clinic every month. In patients on other hospital, we phoned calls to the patients or their families.

Management information
Registered date
2009 Year 06 Month 24 Day
Last modified on
2009 Year 06 Month 24 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002579

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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