UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000040524 |
|---|---|
| Receipt number | R000046260 |
| Scientific Title | Influence on cardiovascular biomarker of the heating-type cigarette |
| Date of disclosure of the study information | 2021/05/26 |
| Last modified on | 2021/05/27 13:38:46 |
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Basic information
Public title
Influence on cardiovascular biomarker of the heating-type cigarette
Acronym
Influence on cardiovascular biomarker of the heating-type cigarette
Scientific Title
Influence on cardiovascular biomarker of the heating-type cigarette
Scientific Title:Acronym
Influence on cardiovascular biomarker of the heating-type cigarette
Region
| Japan |
Condition
Condition
smoker
Classification by specialty
| Not applicable |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To compare the influence on cardiovascular biomarker with the heating-type cigarette and the paper covering cigarette
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
AT-LDL, SAA-LDL
HS-CRP, IK-6
LOX-index
adiponectin
Key secondary outcomes
HbA1c, LDL-C, HDL-C, nonHDL-C
BMI, abdominal circumference
SDS score
Concentration of nicotine, NNK, and NNN in urine
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Behavior,custom | Other |
Interventions/Control_1
Smoking cessation from heating type cigarettes
for 50-60 weeks
Interventions/Control_2
Smoking cessation from paper covering cigarettes
for 50-60 weeks
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
| 35 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1) A smoker: a covering with paper cigarette, a heating-type cigarette or the covering with paper/heating type cigarette every day during the past one week
2) Patients with non-smoking foreign first medical examination in hope of smoking cessation (being 1 year or more after the first medical examination in the treatment in the thing having a non-smoking history of treatment in the last time)
3) The patient that it was obtained the written person's consent
Key exclusion criteria
1) A patient example judged that registration from a state to the final examination is unfavorable from head to foot: Shock state, congestive heart failure decompensated for a serious infectious disease during affection, the immediate nature period of cerebral infarction, myocardial infarction, last years of cancer
2) During the pregnancy, it is a patient with during the nursing or the intention to become pregnant all over the study time
3) The patient who was judged to be inappropriate by other chief physicians
Target sample size
240
Research contact person
Name of lead principal investigator
| 1st name | Tatsuya |
| Middle name | |
| Last name | Morimoto |
Organization
Kyoto Medical Center
Division name
Division of Translational Research, Clinical Research Institute,
Zip code
6128555
Address
1-1, Mukobatacho, Fukakusa, Fushimi-ku, Kyoto, Kyoto
TEL
075-641-9161
morimoto@u-shizuoka-ken.ac.jp
Public contact
Name of contact person
| 1st name | Koji |
| Middle name | |
| Last name | Hasegawa |
Organization
Kyoto Medical Center
Division name
Division of Translational Research, Clinical Research Institute,
Zip code
612-8555
Address
1-1, Mukobatacho, Fukakusa, Fushimi-ku, Kyoto, Kyoto
TEL
075-641-9161
Homepage URL
koj@kuhp.kyoto-u.ac.jp
Sponsor or person
Institute
NHO Kyoto Medical Center
Institute
Department
Personal name
Funding Source
Organization
Self funding
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
Ethical Review Board of Central Clinical Research
Address
2-5-21, Higashigaoka, Meguro-ku, Tokyo
Tel
03-5712-5050
700-kenkyu@mail.hosp.go.jp
Secondary IDs
Secondary IDs
NO
Study ID_1
H31-NHO(HB)-02
Org. issuing International ID_1
Ethical Review Board of Central Clinical Research
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
京都医療センター
埼玉病院
千葉医療センター
村山医療センター
奈良医療センター
栃木医療センター
金沢医療センター
岡山医療センター
近畿中央呼吸器センター
福岡病院
呉医療センター
あわら病院
Other administrative information
Date of disclosure of the study information
| 2021 | Year | 05 | Month | 26 | 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
| 2019 | Year | 08 | Month | 21 | Day |
Date of IRB
| 2019 | Year | 11 | Month | 08 | Day |
Anticipated trial start date
| 2019 | Year | 11 | Month | 08 | Day |
Last follow-up date
| 2022 | Year | 06 | Month | 01 | 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 | 05 | Month | 26 | Day |
Last modified on
| 2021 | Year | 05 | Month | 27 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000046260
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