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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000021533
Receipt No. R000024829
Scientific Title Role of oxidized LDL generation and activation of neutrophils in atherosclerotic lesion formation.
Date of disclosure of the study information 2016/04/01
Last modified on 2020/03/21

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Basic information
Public title Role of oxidized LDL generation and activation of neutrophils in atherosclerotic lesion formation.
Acronym oxLDL and PMN activation
Scientific Title Role of oxidized LDL generation and activation of neutrophils in atherosclerotic lesion formation.
Scientific Title:Acronym oxLDL and PMN activation
Region
Japan

Condition
Condition Not applicable
Classification by specialty
Not applicable
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 This study is to clarify participation of oxidized LDL in activation of human neutrophils.
Basic objectives2 Others
Basic objectives -Others Exploring a factor involved in atherogenesis.
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Activation of neutrophils.
Formation of NETs (neutrophil extracellular traps).
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
20 years-old <=
Age-upper limit
84 years-old >=
Gender Male and Female
Key inclusion criteria Healthy volunteers based on informed consent.
Key exclusion criteria Any healthy volunteers who were drawn blood samples within one month will be excluded.
Target sample size 25

Research contact person
Name of lead principal investigator
1st name Hiroyuki
Middle name
Last name Itabe
Organization Showa University
Division name Division of Biological Chemistry, Department of Pharmaceutical Sciences, School of Pharmacy
Zip code 142-8555
Address 1-5-8 Hatanodai, Shinagawa-ku, Tokyo 142-8555
TEL 03-3784-8217
Email h-itabe@pharm.showa-u.ac.jp

Public contact
Name of contact person
1st name Takashi
Middle name
Last name Obama
Organization Showa University
Division name Division of Biological Chemistry, Department of Pharmaceutical Sciences, School of Pharmacy
Zip code 142-8555
Address 1-5-8 Hatanodai, Shinagawa-ku, Tokyo 142-8555
TEL 03-3784-8218
Homepage URL
Email obama@pharm.showa-u.ac.jp

Sponsor
Institute Showa University
Institute
Department

Funding Source
Organization Government offices
Organization
Division
Category of Funding Organization Japanese Governmental office
Nationality of Funding Organization Japan

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization Showa University Research Administration Center
Address 1-5-8 Hatanodai, Shinagawa-ku, Tokyo
Tel 0337848217
Email surac1@ofc.showa-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 昭和大学薬学部(東京都)

Other administrative information
Date of disclosure of the study information
2016 Year 04 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 Open public recruiting
Date of protocol fixation
2016 Year 03 Month 03 Day
Date of IRB
2018 Year 07 Month 20 Day
Anticipated trial start date
2016 Year 03 Month 25 Day
Last follow-up date
2022 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information The possible role of neutrophils in atherogenesis has not been clarified.

Management information
Registered date
2016 Year 03 Month 18 Day
Last modified on
2020 Year 03 Month 21 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000024829

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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