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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000027048
Receipt No. R000028923
Scientific Title Research on long-term change of cardiovascular markers that determine prognosis after smoking cessation
Date of disclosure of the study information 2017/04/18
Last modified on 2017/10/18

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Basic information
Public title Research on long-term change of cardiovascular markers that determine prognosis after smoking cessation
Acronym Prognostic cardiovascular markers after smoking cessation
Scientific Title Research on long-term change of cardiovascular markers that determine prognosis after smoking cessation
Scientific Title:Acronym Prognostic cardiovascular markers after smoking cessation
Region
Japan

Condition
Condition nicotine dependency
Classification by specialty
Medicine in general Cardiology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 The purpose of this study is to investigate the long-term changes in cardiovascular risk markers including blood fluidity, oxidized low-density-lipoprotein (LDL) (alpha1-Antitrypsin LDL (AT-LDL)) level, and SDS score, an indicator of depression, after smoking cessation and to determine the relationship between these factors and post-cessation weight gain and cardiovascular events.
Basic objectives2 Others
Basic objectives -Others Change and relationship
Trial characteristics_1 Exploratory
Trial characteristics_2 Others
Developmental phase Not applicable

Assessment
Primary outcomes Blood fluidity, serum oxidized LDL AT-LDL level, SDS score
Key secondary outcomes Serum amyloid A low-density lipoprotein (SAA-LDL), Monocyte Chemotactic Protein-1 (MCP-1), LOX index, Leptin, Adiponectin, Cystatin C etc

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 who currently smoke* and visit smoking cessation clinic for treatment
* Definition of current smokers: "Patients who have consumed more than 100 cigarettes or who smoke more than 6 months and who have consumed cigarettes in the past month, everyday or sometimes "
Key exclusion criteria with active cancer
without written informed consent
etc
Target sample size 1000

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Koji Hasegawa
Organization National Hospital Organization Kyoto Medical Center
Division name Division of Translational Research
Zip code
Address 1-1 Mukaihaya-cho, Fukakusa, Fushimi-ku, Kyoto, Japan
TEL 075-641-9161
Email koj@kuhp.kyoto-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Koji Hasegawa
Organization National Hospital Organization Kyoto Medical Center
Division name Division of Translational Research
Zip code
Address 1-1 Mukaihaya-cho, Fukakusa, Fushimi-ku, Kyoto, Japan
TEL 075-641-9161
Homepage URL
Email koj@kuhp.kyoto-u.ac.jp

Sponsor
Institute National Hospital Organization Kyoto Medical Center
Institute
Department

Funding Source
Organization National Hospital Organization
Organization
Division
Category of Funding Organization Other
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
2017 Year 04 Month 18 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 Enrolling by invitation
Date of protocol fixation
2007 Year 02 Month 19 Day
Date of IRB
Anticipated trial start date
2007 Year 04 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information nothing particularly

Management information
Registered date
2017 Year 04 Month 18 Day
Last modified on
2017 Year 10 Month 18 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028923

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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