UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000002117 |
|---|---|
| Receipt number | 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 12:37:03 |
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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
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
Sponsor or person
Institute
Kumamoto University Hospital
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002579
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
