UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000027048 |
|---|---|
| Receipt number | 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 | 2021/12/16 10:47:44 |
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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 | Koji |
| Middle name | |
| Last name | Hasegawa |
Organization
National Hospital Organization Kyoto Medical Center
Division name
Division of Translational Research
Zip code
612-8555
Address
1-1 Mukaihaya-cho, Fukakusa, Fushimi-ku, Kyoto, Japan
TEL
075-641-9161
koj@kuhp.kyoto-u.ac.jp
Public contact
Name of contact person
| 1st name | Koji |
| Middle name | |
| Last name | Hasegawa |
Organization
National Hospital Organization Kyoto Medical Center
Division name
Division of Translational Research
Zip code
612-8555
Address
1-1 Mukaihaya-cho, Fukakusa, Fushimi-ku, Kyoto, Japan
TEL
075-641-9161
Homepage URL
koj@kuhp.kyoto-u.ac.jp
Sponsor or person
Institute
National Hospital Organization Kyoto Medical Center
Institute
Department
Personal name
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
National Hospital Organization Kyoto Medical Center
Address
1-1 Mukaihaya-cho, Fukakusa, Fushimi-ku, Kyoto, Japan
Tel
0756419161
ayasoda@kuhp.kyoto-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
| 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
| 2021 | Year | 12 | Month | 16 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028923
