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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000018747
Receipt No. R000021689
Scientific Title Japan Atherosclerosis Society Cohort Study
Date of disclosure of the study information 2015/09/01
Last modified on 2019/03/14

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Basic information
Public title Japan Atherosclerosis Society Cohort Study
Acronym JAS COHORT STUDY
Scientific Title Japan Atherosclerosis Society Cohort Study
Scientific Title:Acronym JAS COHORT STUDY
Region
Japan

Condition
Condition Dyslipidemia
Classification by specialty
Medicine in general Cardiology Endocrinology and Metabolism
Nephrology Neurology Geriatrics
Neurosurgery
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Survey of dyslipidemia treatment agents and the achievement of the lipid management target level, and the evaluation of the relationship between cardiovascular events, dyslipidemia treatment agents, and the achievement of the lipid management target level of management category in the Japan Atherosclerosis Society (JAS) Guidelines for the Diagnosis and Prevention of Atherosclerotic Cardiovascular Diseases in Japan-2012 Version
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes 1.Survey of Dyslipidemia treatment agents and the achievement of the Lipid Management Target Level of management category in the JAS Guidelines for the Diagnosis and Prevention of Atherosclerotic Cardiovascular Diseases in Japan-2012 Version
2.Relationships among cardiovascular events, dyslipidemia treatment agents, and the achievement of the Lipid Management Target Level of management category in the JAS Guidelines for the Diagnosis and Prevention of Atherosclerotic Cardiovascular Diseases in Japan-2012 Version
Key secondary outcomes Non-fatal myocardial infarction and unstable angina
Non-fatal stroke
Coronary intervention
Atrial fibrillation
Death of cardiovascular cause
Death of non-cardiovascular cause

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
40 years-old <=
Age-upper limit
74 years-old >=
Gender Male and Female
Key inclusion criteria Participants diagnosed as dyslipidemia by the JAS Guidelines for the Diagnosis and Prevention of Atherosclerotic Cardiovascular Diseases in Japan-2012 Version and followed and treated at out-patient clinic including diet therapy
1.Aged 40-74 years
2.Either gender
3.No history of cardiovascular disease
Key exclusion criteria 1.Participants with familiar hypercholesterolemia, familial type III hyperlipidemia, and primary hyperchylomicronemia
2.Past history of stroke
3.Participants who are pregnant or lactating or intend to become pregnant
4.Participants with liver cirrhosis
5.Participants who were diagnosed as hyperthyroidism or hypothyroidism or stable at least 3 months by the treatment before entry
6.Participants who have experienced major surgery within the last 30 days
7.Participants who are currently receiving with oral retinoid agent for acne or psoriasis, systemic corticosteroids, or cyclosporine
8.Participants treated with anti-obesity drugs within the last 3 months
9.Participants who participated in the clinical trial or have been administed any investigational drug within the past 3 months, or the medical equipment
10.Participants who have received or a plan for a bariatric surgery for weight loss (gastric bypass, etc.)
11.Participants who are found to be HIV seropositive
12.Participants who have cancer, except for receiving the appropriate treatment for the localized basal cell skin cancer or mucosa in cervical cancer, or a history of cancer within the past 5 years
13.Participants with geographic elements or social element to limit the participation during the study period (including a transfer), or it is to be expected
14.Participants who are inadequate to enroll the study determined by the research doctor
Target sample size 1500

Research contact person
Name of lead principal investigator
1st name Seiji
Middle name
Last name Umemoto
Organization Japan Atherosclerosis Society
Division name JAS Cohort Study Steering Committee
Zip code 113-0033
Address 28-8, Hongo 3-chome, Bunkyo-ku, Tokyo
TEL 03-5802-7711
Email jascohort@j-athero.or.jp

Public contact
Name of contact person
1st name Seiji
Middle name
Last name Umemoto
Organization Japan Atherosclerosis Society
Division name JAS Cohort Study Steering Committee
Zip code 113-0033
Address 28-8, Hongo 3-chome, Bunkyo-ku, Tokyo
TEL 03-5802-7711
Homepage URL http://www.j-athero.org/other/jas_cohort_study.html
Email jascohort@j-athero.or.jp

Sponsor
Institute JAS Cohort Study Steering Committee
Institute
Department

Funding Source
Organization Japan Atherosclerosis Society
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 Japan Atherosclerosis Society Ethics Committee
Address c/o Nichinai-Kaikan B1 3-28-8 Hongo, Bunkyo-ku,Tokyo 113-0033, Japan
Tel 03-5802-7711
Email jas@j-athero.or.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
2015 Year 09 Month 01 Day

Related information
URL releasing protocol http://www.j-athero.org/
Publication of results Unpublished

Result
URL related to results and publications http://www.j-athero.org/
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 No longer recruiting
Date of protocol fixation
2015 Year 07 Month 06 Day
Date of IRB
Anticipated trial start date
2015 Year 10 Month 01 Day
Last follow-up date
2023 Year 06 Month 30 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information In this cohort study, we will recruit the participants diagnosed with dyslipidemia during the visit to the period of one year from July 6, 2015 at the research participant out-patient institutions, who meet all of the inclusion criteria, and do not fall in any of the exclusion criteria, and observe the development of atherosclerotic disease after the acquisition of the baseline characteristics (age, sex, body weight, hight, sitting blood pressure, weist circumference, lipid profile, glucose, HbA1c, liver function, creatinine, uric acid, ankle brachial index, concomitant drugs, anti-lipidemic drugs and nutritional guidance) of the participants every six months for at least five years.

Management information
Registered date
2015 Year 08 Month 21 Day
Last modified on
2019 Year 03 Month 14 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000021689

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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