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

Email

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


Email

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

Email

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


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name