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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000041810
Receipt No. R000047010
Scientific Title The effects of smoking traditional tobacco and novel tobacco on endothelial function
Date of disclosure of the study information 2020/09/16
Last modified on 2020/09/16

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Basic information
Public title The effects of smoking traditional tobacco and novel tobacco vapor on vascular function
Acronym Traditional tobacco, novel tobacco vapor and vascular function
Scientific Title The effects of smoking traditional tobacco and novel tobacco on endothelial function
Scientific Title:Acronym Traditional tobacco, novel tobacco vapor and endothelial function
Region
Japan

Condition
Condition Smokers (more or equal 10 traditional tobacco per day), age 20-79.
Classification by specialty
Medicine in general Cardiology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To determine the effects of smoking traditional tobacco and novel tobacco vapor on endothelial function.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Endothelial function(FMD)
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Cross-over
Randomization Randomized
Randomization unit Individual
Blinding Open -but assessor(s) are blinded
Control Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Prevention
Type of intervention
Behavior,custom
Interventions/Control_1 Traditional tobacco
Interventions/Control_2 Nobel tobacco vapor
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
80 years-old >
Gender Male
Key inclusion criteria Smokers (more or equal 10 traditional tobacco), age20-79.
Key exclusion criteria Subjects who can not quit smoking for one day.
Target sample size 70

Research contact person
Name of lead principal investigator
1st name Higashi
Middle name
Last name Yukihito
Organization Hiroshima University Hospital
Division name Division of Regeneration and medicine
Zip code 734-8551
Address 1-2-3 Kasumi, Minami-ku, Hiroshima
TEL +81822575831
Email yhigashi@hiroshima-u.ac.jp

Public contact
Name of contact person
1st name Higashi
Middle name
Last name Yukihito
Organization Hiroshima University Hospital
Division name Cardiology
Zip code 734-8551
Address 1-2-3 Kasumi, Minami-ku, Hiroshima
TEL +81822575831
Homepage URL
Email ts5216yt@gmail.com

Sponsor
Institute Division of Regeneration and medicine
Institute
Department

Funding Source
Organization contributions
Smoking Research Fundation
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 Hiroshima University hospital IRB
Address 1-2-3 Kasumi, Minami-ku, Hiroshima
Tel 082-257-5596
Email hugcp@hiroshima-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

Other administrative information
Date of disclosure of the study information
2020 Year 09 Month 16 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
2020 Year 08 Month 26 Day
Date of IRB
2020 Year 09 Month 14 Day
Anticipated trial start date
2020 Year 09 Month 16 Day
Last follow-up date
2021 Year 08 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2020 Year 09 Month 16 Day
Last modified on
2020 Year 09 Month 16 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000047010

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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